Robotic-assisted Rehabilitation of the Extremities

Number: 0778

Table Of Contents

Policy

Scope of Policy

This Clinical Policy Bulletin addresses robotic-assisted rehabilitation of the extremities.

1. Experimental, Investigational, or Unproven

   1. Aetna considers robotic-assisted rehabilitation of the upper limb and lower limb experimental, investigational, or unproven for the following indications (not an all-inclusive list) because of insufficient evidence of its effectiveness:

      1. Humeral fracture
      2. Incomplete spinal cord injury
      3. Neuromuscular diseases (e.g., cerebral palsy, multiple sclerosis, and Parkinson disease)
      4. Stroke
      5. Traumatic brain injury.

   2. The following robotic-assisted rehabilitation interventions and devices are considered experimental, investigational, or unproven because their effectiveness has not been established (not an all-inclusive list):

      1. Intrepid Dynamic Exoskeletal Orthosis (IDEO), the Myomo e100 robotic arm brace, and the Myomo MyoPro myoelectric limb orthosis for medical purposes. The Myomo MyoPro myoelectric limb orthosis are considered exercise equipment by the FDA. Note: Aetna considers the Myomo MyoPro myoelectric limb orthosis (and similar devices) as exercise equipment. Most Aetna benefit plans exclude coverage of exercise equipment;
      2. IpsiHand;
      3. Kinova JACO assistive robot;
      4. Motus Hand and Foot devices;
      5. Obi robotic-assisted feeding device;
      6. Powered hip orthoses for persons with spinal cord injury;
      7. Trexo home robotic-assisted gait trainer;
      8. Walkbot robotic-assisted gait trainer.

2. Related Policies

   • CPB 0505 - Ambulatory Assist Devices: Walkers, Canes, and Crutches
   • CPB 0665 - Constraint-Induced Therapy

Background

According to the American Heart Association, stroke is a major cause of long-term disability in the United States.  Over 50 % of patients with upper limb paresis resulting from stroke face long-term impaired arm function and ensuing disability in daily life (Verbunt et al, 2008).  Reducing the degree of permanent disability is the goal of post-stroke neurorehabilitation programs.  Therapy that incorporates active assistance of motor tasks is a common technique in upper extremity rehabilitation after stroke.  It has been proposed that this type of therapy may be facilitated by robotic devices.  Exoskeletal or "wearable" robots are intended to provide therapeutic exercise or to function as powered orthoses to help compensate for chronic weakness. 

Myoelectric orthotic devices are intended for use in persons with upper limb deficiencies. According to the manufacturers of these devices, they enable individuals who have been afflicted by a stroke or other neuromuscular conditions to self-initiate movement of a partially paralyzed arm using their own muscle signals. They explain that, when the user tries to bend the affected limb, sensors in the brace detect the muscle signal, which activates the motor to move the arm in the desired direction. Examples of this brace include, but may not be limited to, the MyoPro myoelectric limb orthosis and the Myomo e100.

In a randomized controlled pilot study, Kahn and associates (2006a) investigated the effects of robotically administered active-assistive exercise compared to free reaching voluntary exercise in improving arm movement ability after chronic stroke.  A total of 19 individuals at least 1 year post-stroke were randomized into 1 of 2 groups.  One group performed 24 sessions of active-assistive reaching exercise with a simple robotic device, while a 2nd group performed a task-matched amount of un-assisted reaching.  The main outcome measures were range and speed of supported arm movement, range, straightness and smoothness of un-supported reaching, and the Rancho Los Amigos Functional Test of Upper Extremity Function.  There were significant improvements with training for range of motion (ROM) and velocity of supported reaching, straightness of un-supported reaching, and functional movement ability.  These improvements were not significantly different between the 2 groups.  The group that performed un-assisted reaching exercise improved the smoothness of their reaching movements more than the robot-assisted group.  The authors concluded that improvements with both forms of exercise confirmed that repeated, task-related voluntary activation of the damaged motor system is a key stimulus to motor recovery following stroke and that robotically assisting in reaching improved arm movement ability, although it did not provide any detectable, additional value beyond the movement practice that occurred concurrently with it.  The authors stated that the inability to detect any additional value of robot-assisted reaching may have been due to the limited sample size of the study and the specific diagnoses of the participants, or the inclusion of only individuals with chronic stroke.

The Myomo e100 robotic arm brace (Myomo, Inc., Boston, MA) is an electromechanically powered elbow brace that received 510(k) marketing clearance in April 2007.  It is intended to facilitate arm movement and maintain or increase ROM of the arm for stroke patients undergoing rehabilitation.  The device contains a computerized system that detects changes in the patient's resting muscle potential through electromyographic (EMG) sensors placed on the skin.  The computerized system translates these electrical signals into the desired motion and then responds in real time with a power boost from the device's motorized elbow brace to assist the desired motion.  The device would be included as part of prescribed physical therapy to enable stroke patients to exercise that would otherwise be unable to independently do so.  The amount of assistance provided by the Myomo e100 can vary as the patient fatigues or gains strength.  The objective of the EMG-triggered action is to engage and reinforce both neurological and motor pathways to help the patient relearn how to move affected muscles.  The Myomo e100 can be configured for either the left or right arm, and to detect electrical activity from either the biceps or triceps.  Unlike some earlier robotic therapy devices that were stationary, the Myomo e100 is a wearable device.  It is designed to act as an aid for exercise training and may be developed for use as an actively powered orthosis to assist with difficult motions.

Stein et al (2007) reported the results of the Myomo e100 device on 6 stroke patients with severe chronic hemiparesis.  Each patient used the device for a total of 18 hours of exercise therapy (2 to 3 hours per week) for a period of 6 weeks.  The average age of the patients was 53 years, and the average time since their stroke was 3.67 years.  A 7th patient did not have sufficient EMG signals to control the device.  Patients performed exercises including a defined set of functional tasks (moving blocks or turning light switches on or off) with the robotic brace.  They were able to control the motorized brace to assist in these motions.  Assessment by both the Fugl-Meyer scale and the modified Ashworth scale (a measure of muscle spasticity) showed improvement in upper extremity motor function.  The authors concluded that the EMG-controlled powered elbow orthoses show promise as a new modality for assisted exercise training after stroke.  They stated that further studies are needed to confirm these preliminary results.

Chang et al (2007) analyzed the results of a training program (40 mins/session, 3 sessions/week for 8 weeks) consisting of 10 mins of conventional rehabilitation and 30 mins of robot-aided, bilateral force-induced, isokinetic arm movement training to improve paretic upper-limb motor function.  The post-test and retention test in arm motor function significantly improved in terms of grip (p = 0.009), push (p = 0.001), and pull (p = 0.001) strengths, and Fugl-Meyer Assessment upper-limb scale (p < 0.001).  Reaching kinematics significantly improved in terms of movement time (p = 0.015), peak velocity (p = 0.035), percentage of time to peak velocity (p = 0.004), and normalized jerk score (p = 0.008).  Improvement in reaching ability was not sustained in the retention test.  The authors concluded that these preliminary results showed that conventional rehabilitation combined with robot-aided, bilateral force-induced, isokinetic arm training might enhance the recovery of strength and motor control ability in the paretic upper limb of patients with chronic stroke.

A Cochrane systematic review (Mehrholz et al, 2008) evaluated the evidence of the effectiveness of electromechanical and robot-assisted training for improving arm function after stroke.  Randomized controlled trials comparing electromechanical and robot-assisted arm training for recovery of arm function with other rehabilitation interventions or no treatment for patients after stroke were selected for review.  Eleven trials (328 participants) met the inclusion criteria.  The authors reported that electromechanical and robot-assisted arm training did not improve ADLs but arm motor function and arm motor strength improved.  These results must be interpreted with caution, however, because there were variations between the trials in the duration, amount of training and type of treatment, and in the patient characteristics.  The authors concluded, "It is, therefore, not clear if such devices should be applied in routine rehabilitation, or when and how often they should be used."  A Cochrane systematic evidence review also found that there is insufficient evidence for the use of robotic-assisted gait training after spinal cord injury (SCI) (Mehrholz et al, 2008).  Two review authors independently selected trials for inclusion, assessed trial quality and extracted the data.  The primary outcomes were the speed of walking and walking capacity at follow-up.  A total of 4 randomized controlled trials (RCTs) involving 222 patients were included in this review.  Overall, the results were inconclusive.  There was no statistically significant effect of locomotor training on walking function after SCI comparing body-weight supported treadmill training with or without functional electrical stimulation or robotic-assisted locomotor training.  The authors concluded that there is insufficient evidence from RCTs to conclude that any one locomotor training strategy improves walking function more than another for people with SCI.  Research in the form of large RCTs is needed to address specific questions about the type of locomotor training which might be most effective in improving walking function of people with SCI.

In a RCT, Hornby et al (2008) examined the effects of robotic-assisted versus therapist-assisted locomotor training (LT).  Both groups received 12 LT sessions for 30 mins at similar speeds, with guided symmetrical locomotor assistance using a robotic orthosis versus manual facilitation from a single therapist using an assist-as-needed paradigm.  Outcome measures included gait speed and symmetry, and clinical measures of activity and participation.  Greater improvements in speed and single limb stance time on the impaired leg were observed in subjects who received therapist-assisted LT, with larger speed improvements in those with less severe gait deficits.  Perceived rating of the effects of physical limitations on quality of life improved only in subjects with severe gait deficits who received therapist-assisted LT.  The authors concluded that therapist-assisted LT facilitates greater improvements in walking ability in ambulatory stroke survivors as compared to a similar dosage of robotic-assisted LT.

In a multi-center, randomized clinical trial, Hilder and colleagues (2009) compared the effectiveness of robotic-assisted gait training with the Lokomat to conventional gait training in individuals with subacute stroke.  A total of 63 participants less than 6 months post-stroke with an initial walking speed between 0.1 to 0.6 m/s completed the study.  All participants received 24 1-hr sessions of either Lokomat or conventional gait training.  Outcome measures were evaluated prior to training, after 12 and 24 sessions, and at a 3-month follow-up examination.  Self-selected overground walking speed and distance walked in 6 mins were the primary outcome measures, whereas secondary outcome measures included balance, mobility and function, cadence and symmetry, level of disability, and quality of life measures.  Participants who received conventional gait training experienced significantly greater gains in walking speed (p = 0.002) and distance (p = 0.03) than those trained on the Lokomat.  These differences were maintained at the 3-month follow-up evaluation.  Secondary measures were not different between the 2 groups, although a 2-fold greater improvement in cadence was observed in the conventional versus Lokomat group.  The authors concluded that for subacute stroke patients with moderate-to-severe gait impairments, the diversity of conventional gait training interventions appears to be more effective than robotic-assisted gait training for facilitating returns in walking ability.

In a randomized clinical trial, Lewek et al (2009) determined whether LT with physical assistance as needed was superior to guided, symmetrical, robotic-assisted LT for improving kinematic coordination during walking post-stroke.  A total of 19 people with chronic stroke (greater than 6 months' duration) participating in a RCT comparing therapist-assisted versus robotic-assisted LT were recruited.  Prior to and following 4 weeks of LT, gait analysis was performed at each participant's self-selected speed during overground walking.  Kinematic coordination was defined as the consistency of intra-limb hip and knee angular trajectories over repeated gait cycles and was compared before and after treatment for each group.  Locomotor training with therapist assistance resulted in significant improvements in the consistency of intra-limb movements of the impaired limb.  Providing consistent kinematic assistance during robotic-assisted LT did not result in improvements in intra-limb consistency.  Only minimal changes in discrete kinematics were observed in either group.  The authors concluded that coordination of intra-limb kinematics appears to improve in response to LT with therapist assistance as needed.  Fixed assistance, as provided by this form of robotic guidance during LT, however, did not alter intra-limb coordination.

In a preliminary study, Kutner et al (2010) examined changes in patient-reported, health-related quality of life associated with robotic-assisted therapy combined with reduced therapist-supervised training in patients with subacute stroke.  A total of 17 individuals who were 3 to 9 months post-stroke participated in this study.  Sixty hours of therapist-supervised repetitive task practice (RTP) was compared with 30 hours of RTP combined with 30 hours of robotic-assisted therapy.  Participants completed the Stroke Impact Scale (SIS) at baseline, immediately post-intervention, and 2 months post-intervention.  Change in SIS score domains was assessed in a mixed model analysis.  The combined therapy group had a greater increase in rating of mood from pre-intervention to post-intervention, and the RTP-only group had a greater increase in rating of social participation from pre-intervention to follow-up.  Both groups had statistically significant improvement in activities of daily living and instrumental activities of daily living scores from pre-intervention to post-intervention.  Both groups reported significant improvement in hand function post-intervention and at follow-up, and the magnitude of these changes suggested clinical significance.  The combined therapy group had significant improvements in stroke recovery rating post-intervention and at follow-up, which appeared clinically significant; this also was true for stroke recovery rating from pre-intervention to follow-up in the RTP-only group.   The major limitation of this study was that outcome of 30 hours of RTP in the absence of robotic-assisted therapy remain unknown.  The authors concluded that robotic-assisted therapy may be an effective alternative or adjunct to the delivery of intensive task practice interventions to enhance hand function recovery in patients with stroke.  These prelininary findings need to be validated by further investigation.

In a case-series study, Meyer-Heim and colleagues (2009) measured functional gait improvements of robotic-assisted locomotion training in children with cerebral palsy (CP).  A total of 22 children (mean age of 8.6 years, range of 4.6 to 11.7) with CP and a gross motor function classification system level II to IV were enrolled in this study.  Subjects received 3 to 5 sessions of 45 to 60 mins/week during a 3- to 5-week period of driven gait orthosis training.  Main outcome measures included 10-meter walk test (10MWT), 6-min walk test (6MinWT), gross motor function measure (GMFM-66) dimension D (standing) and dimension E (walking), and functional ambulation categories (FAC).  The mean (SD) maximum gait speed (0.78 (0.57) to 0.91 (0.61) m/s; p < 0.01) as well as the mean (SD) dimension D of the GMFM-66 (40.3 % (31.3 %) to 46.6 % (28.7 %); p < 0.05) improved significantly after the intervention period.  The mean (SD) 6MinWT (176.3 (141.8) to 199.5 (157.7) m), the mean FAC (2.6 (1.7) to 3.0 (1.6)) and the mean (SD) dimension E of the GMFM-66 (29.5 % (30.3 %) to 31.6 % (29.2 %)) also showed an increase, but did not reach a statistically significant level.  These authors concluded that these findings suggested that children with CP benefit from robotic-assisted gait training in improving functional gait parameters.  These findings need to be validated by well-deisgned studies.

In a RCT, Druzbicki et al (2013) evaluated gait in children with spastic diplegic CP (n = 52) rehabilitated with the use of Lokomat active orthosis.  Temporo-spatial parameters of gait and selected kinematic parameters were assessed.  Childrem from the study group used active orthosis in addition to following a program of individual exercises.  Children in the control group participated only in individual exercises.  The difference between the initial and control examinations was statistically insignificant.  After the program was finished, there was a slight improvement in walking speed in both groups.  Improvement in the mean walking speed was not significantly different between the groups (p = 0.5905).  Range of motion decreased slightly in both groups, and the difference between mean amounts of change was not significant (p = 0.8676).  There was significant improvement in maximal range of flexion in the hip joint (p = 0.0065) in the study.  It was shown that with a decrease in the mean value of adduction in hip joint, the mean walking speed increased (r = -0.53, p = 0.0011).  The authors concluded that this study had several limitations, thus, these results should be regarded as preliminary.  Moreover, they stated that further research consistent with the above indications is needed to investigate the impact of this new treatment option in patients with CP.

Swinnen et al (2010) evaluated the quality of current evidence as to the effectiveness of RAGT in patients with SCI, focusing on walking ability and performance.  A search was conducted in MEDLINE, Web of Knowledge, Cochrane Library, Physiotherapy Evidence Database (PEDro) and Digital Academic Repositories (DAREnet) (1990 to 2009).  Key words included "spinal cord injury", "(robot-assisted) gait rehabilitation" and "driven gait orthosis".  Articles were included when complete and incomplete adult spinal cord injured patients participated in RAGT intervention studies.  The methodological quality was rated independently by 2 researchers using "van Tulder criteria list" and "evaluation of quality of an intervention study".  Descriptive analyses were performed using the Population Intervention Comparison Outcome (PICO) method.  Two RCTs (mean quality score: 11.5/19) and 4 pre-experimental trials (mean quality score: 24.25 (standard deviation; SD 0.28/48) involving 43 patients with incomplete, acute or chronic lesions between C3 and L1 were analysed.  Five studies used the Lokomat and 1 used the LokoHelp.  Although some improvements were reported related to body functions and activities, there is insufficient evidence to draw firm conclusions, due to small samples sizes, methodological flaws and heterogeneity of training procedures.  The authors concluded that there is currently no evidence that RAGT improves walking function more than other locomotor training strategies.  They stated that well-designed RCTs are needed.

The Veterans Health Administration and the Department of Defense's clinical practice guideline for the management of stroke rehabilitation (2010) stated that "[t]here is no sufficient evidence supporting use of robotic devices during gait training in patients post stroke" (regarding gait training strategies for lower extremities).

Schwartz et al (2011) evaluated the effect of an additive RAGT using the Lokomat system on the neurological and functional outcomes of patients with subacute SCI.  A total of 28 subacute SCI patients were treated by RAGT, 2 to 3 times a week, 30 to 45 mins every treatment, concomitantly with regular physiotherapy.  As control, for each patient, these investigators matched a comparable patient treated in the same department in previous years, according to age, severity of injury, level of injury and cause.  The main outcomes were: the AIS (American Spinal Injury Association impairment scale) the spinal cord independence measurement (SCIM) score, the walking index for SCI II (WISCI II) and functional ambulation category scale (FAC).  At the end of rehabilitation, both groups showed a significant improvement in both the FAC score and the WISCI score (p < 0.01) without differences between the groups.  Functional abilities, according to the SCIM score, were also improved, with a significant interaction effect; the RAGT patients improve by 30 +/- 20 points, which was significantly greater gain as compared with the controls, 21 +/- 14 points (p = 0.05).  This improvement was mainly due to the change in the SCIM motor subscales.  The authors concluded that RAGT is an important additional treatment to improve the functional outcome of subacute SCI patients.  They stated that larger, controlled studies are still needed to determine the optimal timing and protocol design for the maximal efficacy of RAGT in SCI patients.

In an open-label pilot study, Stein et al (2011) tested a new robotic device for hand rehabilitation in stroke survivors.  A total of 12 individuals with chronic moderate hemiparesis after stroke were enrolled in this study.  Participants underwent a 6-week training program using a hand robotic device.  They received a total of 18 hours of robotic therapy.  Improvements were found in multiple measures of motor performance, including the Upper Extremity Fugl-Meyer test, the Motor Activity Log, the Manual Ability Measure-36, and the Jebsen Hand Function Test.  All subjects tolerated the treatment well and no complications were observed.  The authors concluded that robotic therapy for hand paresis after stroke is safe and feasible, and further studies of efficacy are justified by these preliminary results.

Norouzi-Gheidari et al (2012) systematically reviewed and analyzed the literature to find RCTs that employed robotic devices in upper-limb rehabilitation of people with stroke.  Out of 574 studies, 12 matching the selection criteria were found.  The Fugl-Meyer, Functional Independence Measure, Motor Power Scale, and Motor Status Scale outcome measures from the selected RCTs were pooled together, and the corresponding effect sizes were estimated.  These researchers found that when the duration/intensity of conventional therapy (CT) was matched with that of the robot-assisted therapy (RT), no difference exists between the intensive CT and RT groups in terms of motor recovery, ADL, strength, and motor control.  However, depending on the stage of recovery, extra sessions of RT in addition to regular CT are more beneficial than regular CT alone in motor recovery of the hemiparetic shoulder and elbow of patients with stroke; gains are similar to those that have been observed in intensive CT.

In a Cochrane review, Mehrholz et al (2012) evaluated the effectiveness of electromechanical and robot-assisted arm training for improving generic ADL, arm function, and arm muscle strength in patients after stroke.  These investigators also assessed the acceptability and safety of the therapy.  They searched the Cochrane Stroke Group's Trials Register (last searched July 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 7), MEDLINE (1950 to July 2011), EMBASE (1980 to July 2011), CINAHL (1982 to July 2011), AMED (1985 to July 2011), SPORTDiscus (1949 to July 2011), PEDro (searched August 2011), COMPENDEX (1972 to July 2011), and INSPEC (1969 to July 2011).  They also hand-searched relevant conference proceedings, searched trials and research registers, checked reference lists, and contacted trialists, experts and researchers in the field, as well as manufacturers of commercial devices.  Randomized controlled trials comparing electromechanical and robot-assisted arm training for recovery of arm function with other rehabilitation or placebo interventions, or no treatment, for patients after stroke were selected for analysis.  Two review authors independently selected trials for inclusion, assessed trial quality, and extracted data.  They contacted trialists for additional information.  They analysed the results as standardized mean differences (SMDs) for continuous variables and risk differences (RDs) for dichotomous variables.  These researchers included 19 trials (involving 666 participants) in this updated review.  Electromechanical and robot-assisted arm training did improve activities of daily living (SMD 0.43, 95 % confidence interval (CI): 0.11 to 0.75, p = 0.009, I(2) = 67 %) as well as arm function (SMD 0.45, 9 5% CI: 0.20 to 0.69, p = 0.0004, I(2) = 45 %), but arm muscle strength did not improve (SMD 0.48, 95 % CI: -0.06 to 1.03, p = 0.08, I(2) = 79 %).  Electromechanical and robot-assisted arm training did not increase the risk of patients to drop-out (RD 0.00, 95 % CI: -0.04 to 0.04, p = 0.82, I(2) = 0.0 %), and adverse events were rare.  The authors concluded that patients who receive electromechanical and robot-assisted arm training after stroke are more likely to improve their generic ADL.  Paretic arm function may also improve, but not arm muscle strength.  However, the authors stated that results must be interpreted with caution because there were variations between the trials in the duration and amount of training, type of treatment, and in the patient characteristics.

Hussain et al (2011) stated that the rehabilitation engineering community is working towards the development of robotic devices that can assist during gait training of patients suffering from neurologic injuries such as stroke and SCI.  The field of robot-assisted treadmill training has rapidly evolved during the last decade.  The robotic devices can provide repetitive, systematic and prolonged gait training sessions.  These researchers presented a review of the treadmill-based robotic gait training devices.  An overview of design configurations and actuation methods used for these devices was provided.  Training strategies designed to actively involve the patient in robot-assisted treadmill training were studied.  These training strategies assist the patient according to the level of disability and type of neurologic injury.  The authors stated that although the effectiveness of these training strategies is not clinically proven, adaptive strategies may result in substantial improvements.

Alcobendas-Maestro et al (2012) compared a walking re-education program using Lokomat with conventional over-ground training among individuals with incomplete SCI of both traumatic and non-traumatic etiology.  A total of 80 participants from 3 to 6 months after onset admitted to 1 site for rehabilitation were included in a single-blind RCT of 2 parallel groups, with blind evaluation by independent observers.  Patients received 40 walking re-education sessions of equal time using a Lokomat program with over-ground practice or over-ground mobility therapy alone.  Primary measurements of outcome were walking speed and the WISCI II; secondary outcomes were the 6-min walk test, locomotor section of the functional independence measure, lower extremity motor score (LEMS), Ashworth Scale, and visual analog scale for pain.  No significant differences were found at entry between treatment groups.  Walking speed for Lokomat (0.4 m/s [0.6 to 0.2]) and over-ground therapy (0.3 m/s [0.5 to 0.2]) groups did not differ.  The WISCI II for the Lokomat group (16 [8.5 to 19]) was better than for over-ground therapy (9 [8 to 16]).  The 6-min walk test and LEMS displayed significant differences in favor of Lokomat therapy but were not corrected for multiple comparisons.  The authors concluded that robotic-assisted training was equivalent to conventional walk training in patients with a variety of non-progressive spinal cord pathologies for walking speed, but the need for orthotics and assistive devices was reduced, perhaps because of greater leg strength in the robotic group.

Morawietz and Moffat (2013) provided an overview of, and evaluated the current evidence on, locomotor training approaches for gait rehabilitation in individuals with incomplete SCI to identify the most effective therapies.  The following electronic databases were searched systematically from first date of publication until May 2013: Allied and Complementary Medicine Database, Cumulative Index to Nursing and Allied Health Literature, Cochrane Database of Systematic Reviews, Medline, Physiotherapy Evidence Database, and PubMed.  References of relevant clinical trials and systematic reviews were also hand-searched.  Only RCTs evaluating locomotor therapies after incomplete SCI in an adult population were included.  Full-text versions of all relevant articles were selected and evaluated by both authors.  Eligible studies were identified, and methodological quality was assessed with the Physiotherapy Evidence Database scale.  Articles scoring less than 4 points on the scale were excluded.  Sample population, interventions, outcome measures, and findings were evaluated with regard to walking capacity, velocity, duration, and quality of gait.  Data were analyzed by systematic comparison of findings.  A total of 8 articles were included in this review; 5 compared body-weight-supported treadmill training (BWSTT) or robotic-assisted BWSTT with conventional gait training in acute/subacute subjects (less than or equal to 1 year post-injury).  The remaining studies each compared 3 or 4 different locomotor interventions in chronic participants (greater than1y post-injury).  Sample sizes were small, and study designs differed considerably impeding comparison.  Only minor differences in outcomes measures were found between groups.  Gait parameters improved slightly more after BWSTT and robotic gait training for acute participants.  For chronic participants, improvements were greater after BWSTT with functional electrical stimulation (FES) and over-ground training with FES/body-weight support compared with BWSTT with manual assistance, robotic gait training, or conventional physiotherapy.  The authors concluded that evidence on the effectiveness of locomotor therapy is limited.  All approaches show some potential for improvement of ambulatory function without superiority of 1 approach over another.  They stated that more research on this topic is required.

Dobkin and Duncan (2012) stated that body weight-supported treadmill training (BWSTT) and robotic-assisted step training (RAST) have not, so far, led to better outcomes than a comparable dose of progressive over-ground training (OGT) for disabled persons with stroke, SCI, multiple sclerosis (MS), Parkinson's disease (PD), or CP.  The conceptual bases for these promising rehabilitation interventions had once seemed quite plausible, but the results of well-designed, RCTs have been disappointing.  The authors re-assessed the under-pinning concepts for BWSTT and RAST, which were derived from mammalian studies of treadmill-induced hind-limb stepping associated with central pattern generation after low thoracic spinal cord transection, as well as human studies of the triple-crown icons of task-oriented locomotor training, massed practice, and activity-induced neuroplasticity.  The authors retrospectively considered where theory and practice may have fallen short in the pilot studies that aimed to produce thoroughbred interventions.  Based on these shortcomings, the authors moved forward with recommendations for the future development of workhorse interventions for walking.  The authors concluded that in the absence of evidence for physical therapists to employ these strategies, however, BWSTT and RAST should not be provided routinely to disabled, vulnerable persons in place of OGT outside of a scientifically conducted efficacy trial.

Vaney et al (2012) examined if RAGT (Lokomat) is superior to over-ground walking training in terms of quality of life, activity level, and gait in patients with MS.  A total of 67 patients with MS with the Expanded Disability Status Scale (EDSS) 3.0 to 6.5 were randomized to walking or RAGT, in addition to multi-modal rehabilitation.  Primary outcomes were walking speed, activity level (estimated metabolic equivalent, metabolic equivalents [METs], using an accelerometer), and quality of life (Well-Being visual analog scale (VAS) and EQ-5D European VAS.  In all, 49 patients finished the interventions.  Mean age was 56 years (range of 36 to 74 years), mean EDSS was 5.8 (3.0 to 6.5), and the preferred walking speed at baseline was 0.56 m/s (0.06 to 1.43 m/s).  Before rehabilitation, participants spent on average 68 min/day at an MET greater than or equal to 3.  The walking group improved gait speed non-significantly more than the RAGT; the upper bound of the CI did not exclude a clinically relevant benefit (defined as a difference of 0.05 m/s) in favor of the walking group; the lower bound of the CI did exclude a clinically important benefit in favor of the Lokomat.  Quality of life improved in both groups, with a non-significant between-group difference in favor of the walking group. Both groups had reduced their activity by 8 weeks after the rehabilitation.  The authors concluded that it is unlikely that RAGT is better than over-ground walking training in patients with an EDSS between 3.0 and 6.5.

In a RCT, Picelli et al (2012) examined if a rehabilitation program of RAGT is more effective than conventional physiotherapy to improve walking in patients with PD.  A total of 41 patients with PD were randomly assigned to 45-min treatment sessions (12 in all), 3 days a week, for 4 consecutive weeks of either robotic stepper training (RST; n = 21) using the Gait Trainer or physiotherapy (PT; n = 20) with active joint mobilization and a modest amount of conventional gait training.  Participants were evaluated before, immediately after, and 1 month after treatment.  Primary outcomes were 10-m walking speed and distance walked in 6 mins.  Baseline measures revealed no statistical differences between groups, but the PT group walked 0.12 m/s slower; 5 patients withdrew.  A statistically significant improvement was found in favor of the RST group (walking speed 1.22 ± 0.19 m/s [p = 0.035]; distance 366.06 ± 78.54 m [p < 0.001]) compared with the PT group (0.98 ± 0.32 m/s; 280.11 ± 106.61 m).  The RAGT mean speed increased by 0.13 m/s, which is probably not clinically important.  Improvements were maintained 1 month later.  The authors concluded that RAGT may improve aspects of walking ability in patients with PD.  Moreover, they stated that future trials should compare robotic assistive training with treadmill or equal amounts of over-ground walking practice.

Yang and colleagues (2014) evaluated the plantar pressure distribution during the robotic-assisted walking, guided through normal symmetrical hip and knee physiological kinematic trajectories, with unassisted walking in post-stroke hemiplegic patients.  A total of 15 hemiplegic stroke patients (who were able to walk a minimum of 10 meters independently but with asymmetric gait patterns) were enrolled in this study.  All the patients performed both the robotic-assisted walking (Lokomat) and the unassisted walking on the treadmill with the same body support in random order.  The contact area, contact pressure, trajectory length of center of pressure (COP), temporal data on both limbs and asymmetric index of both limbs were obtained during both walking conditions, using the F-Scan in-shoe pressure measurement system.  The contact areas of mid-foot and total foot on the affected side were significantly increased in robotic-assisted walking as compared to unassisted walking (p < 0.01).  The contact pressures of mid-foot and total foot on affected limbs were also significantly increased in robotic-assisted walking (p < 0.05).  The antero-posterior and medio-lateral trajectory length of COP were not significantly different between the 2 walking conditions, but their trajectory variability of COP was significantly improved (p < 0.05).  The asymmetric index of area, stance time, and swing time during robotic-assisted walking were statistically improved as compared with unassisted walking (p < 0.05).  The authors concluded that the robotic-assisted walking may be helpful in improving the gait stability and symmetry, but not the physiologic ankle rocker function.

In a randomized controlled trial, Gandolfi and associates (2014) compared the effectiveness of end-effector RAGT and sensory integration balance training (SIBT) in improving walking and balance performance in patients with MS.  A total of 22 patients with MS (EDSS: 1.5 to 6.5) were randomly assigned to 2 groups.  The RAGT group (n = 12) underwent end-effector system training; the SIBT group (n = 10) underwent specific balance exercises.  Each patient received 12 50-min treatment sessions (2 days/week).  A blinded rater evaluated patients before and after treatment as well as 1 month post-treatment.  Primary outcomes were walking speed and Berg Balance Scale.  Secondary outcomes were the Activities-specific Balance Confidence Scale, Sensory Organization Balance Test, Stabilometric Assessment, Fatigue Severity Scale, cadence, step-length, single and double support time, Multiple Sclerosis Quality of Life-54.  Between groups comparisons showed no significant differences on primary and secondary outcome measures over time.  Within group comparisons showed significant improvements in both groups on the Berg Balance Scale (p = 0.001).  Changes approaching significance were found on gait speed (p = 0.07) only in the RAGT group.  Significant changes in balance task-related domains during standing and walking conditions were found in the SIBT group.  The authors concluded that balance disorders in patients with MS may be ameliorated by RAGT and by SIBT.

In a randomized controlled trial, Picelli and colleagues (2015) compared RAGT versus balance training for reducing postural instability in patients with PD.  The secondary aim was to compare their effects on the level of confidence during activities of daily living requiring balance, functional mobility and severity of disease.  A total of 66 patients with PD at Hoehn and Yahr Stage 3 were enrolled in this study.  After balanced randomization, all patients received 12, 45-min treatment sessions, 3 days a week, for 4 consecutive weeks.  A group underwent RAGT with progressive gait speed increasing and body-weight support decreasing.  The other group underwent balance training aimed at improving postural reactions (self and externally induced destabilization, coordination, loco-motor dexterity exercises).  Patients were evaluated before, after and 1 month post-treatment.  Main outcome measure was Berg Balance Scale; secondary outcomes included Activities-Specific Balance Confidence Scale; Timed Up and Go Test; Unified Parkinson's Disease Rating Scale.  No significant differences were found between the groups for the Berg Balance Scale either immediately after intervention (mean score in the RAGT group 51.58 ± 3.94; mean score in the balance training group 51.15 ± 3.46), or 1-month follow-up (mean score in the robotic training group 51.03 ± 4.63; mean score in the balance training group 50.97 ± 4.28).  Similar results were found for all the secondary outcome measures.  The authors concluded that these findings indicated that RAGT is not superior to balance training for improving postural instability in patients with mild-to-moderate PD.

Rodger and colleagues (2020) noted that loss of arm function is common following stroke; and robot-assisted training may improve arm outcomes.  In an observer-blind, multi-center,  RCT with embedded health economic and process evaluations, these researchers examined the clinical effectiveness and cost-effectiveness of robot-assisted training, compared with an EULT program and with usual care.  The trial was set in 4 NHS trial centers.  Subjects were patients with moderate or severe upper limb functional limitation, between 1 week and 5 years following the 1st stroke.  Robot-assisted training using the Massachusetts Institute of Technology-Manus robotic gym system (InMotion commercial version, Interactive Motion Technologies, Inc., Watertown, MA), an EULT program comprising repetitive functional task practice, and usual care.  The primary outcome was upper limb functional recovery “success” (assessed using the Action Research Arm Test) at 3 months.  Secondary outcomes at 3 and 6 months were the Action Research Arm Test results, upper limb impairment (measured using the Fugl-Meyer Assessment), ADL (measured using the Barthel Activities of Daily Living Index), quality of life (QOL; measured using the Stroke Impact Scale), resource use costs and quality-adjusted life-years (QALYs).  A total of 770 subjects were randomized (robot-assisted training, n = 257; EULT, n = 259; usual care, n = 254).  Upper limb functional recovery “success” was achieved in the robot-assisted training [103/232 (44 %)], EULT [118/234 (50 %)] and usual care groups [85/203 (42 %)].  These differences were not statistically significant; the adjusted ORs were as follows: robot-assisted training versus usual care, 1.2 (98.33 % CI: 0.7 to 2.0); EULT versus usual care, 1.5 (98.33 % CI: 0.9 to 2.5); and robot-assisted training versus EULT, 0.8 (98.33 % CI: 0.5 to 1.3).  The robot-assisted training group had less upper limb impairment (as measured by the Fugl-Meyer Assessment motor subscale) than the usual care group at 3 and 6 months.  The EULT group had less upper limb impairment (as measured by the Fugl-Meyer Assessment motor subscale), better mobility (as measured by the Stroke Impact Scale mobility domain) and better performance in ADL (as measured by the Stroke Impact Scale activities of daily living domain) than the usual care group, at 3 months.  The robot-assisted training group performed less well in ADL (as measured by the Stroke Impact Scale ADL domain) than the EULT group at 3 months.  No other differences were clinically important and statistically significant.  Subjects found the robot-assisted training and the EULT group programs acceptable.  Neither intervention, as provided in this trial, was cost-effective at current National Institute for Health and Care Excellence willingness-to-pay thresholds for a QALY.  The authors concluded that robot-assisted training did not improve upper limb function compared with usual care.  Although robot-assisted training improved upper limb impairment, this did not translate into improvements in other outcomes; EULT resulted in potentially important improvements on upper limb impairment, in performance of ADL, and in mobility.  Neither intervention was cost-effective.  Moreover, these researchers stated that further research is needed to find ways to translate the improvements in upper limb impairment observed with robot-assisted training into improvements in upper limb function and ADL.  Innovations to make rehabilitation programs more cost-effective are needed.

The authors stated that the drawbacks of this study were pragmatic inclusion criteria led to the recruitment of some subjects with little prospect of recovery.  The attrition rate was higher in the usual care group than in the robot-assisted training or EULT groups, and differential attrition was a potential source of bias.  They stated that obtaining accurate information regarding the usual care that subjects were receiving was a challenge.

Fernandez-Garcia and associates (2021) examined if robot-assisted training is cost-effective compared with an EULT program or usual care.  This trial was carried out in 4 National Health Service (NHS) centers in the UK: Queen's Hospital, Barking, Havering and Redbridge University Hospitals NHS Trust; Northwick Park Hospital, London Northwest Healthcare NHS Trust; Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde; and North Tyneside General Hospital, Northumbria Healthcare NHS Foundation Trust.  A total of 770 subjects aged 18 years or older with moderate or severe upper limb functional limitation from first-ever stroke were included in this study; they were randomized to 1 of 3 programs provided over a 12-week period: robot-assisted training plus usual care; the EULT program plus usual care or usual care.  Main economic outcome measures included mean healthcare resource use; costs to the NHS and personal social services in 2018 pounds; utility scores based on EQ-5D-5L responses and QALYs.  Cost-effectiveness reported as incremental cost per QALY and cost-effectiveness acceptability curves.  At 6 months, on average usual care was the least costly option (£3,785) followed by EULT (£4,451) with robot-assisted training being the most-costly option (£5,387).  The MD in total costs between the usual care and robot-assisted training groups (£1,601) was statistically significant (p < 0.001).  Mean QALYs were highest for the EULT group (0.23) but no evidence of a difference (p = 0.995) was observed between the robot-assisted training (0.21) and usual care groups (0.21).  The incremental cost per QALY at 6 months for subjects randomized to EULT compared with usual care was £74,100.  Cost-effectiveness acceptability curves showed that robot-assisted training was unlikely to be cost-effective and that EULT had a 19 % chance of being cost-effective at the £20,000 willingness to pay (WTP) threshold.  Usual care was most likely to be cost-effective at all the WTP values considered in the analysis.  The authors concluded that the cost-effectiveness analysis suggested that neither robot-assisted training nor EULT, as delivered in this trial, was likely to be cost-effective at any of the cost per QALY thresholds considered.

Reis and co-workers (2021) stated that robot-assisted therapy and non-invasive brain stimulation (NIBS) are promising strategies for stroke rehabilitation.  In a systematic review and meta-analysis, these researchers examined the evidence of NIBS as an add-on intervention to robotic therapy to improve outcomes of upper-limb motor impairment or activity in individuals with stroke.  This study was carried out according to the PRISMA protocol.  A total of 7 databases and gray literature were systematically searched by 2 reviewers, and 1,176 registers were accessed; 8 randomized clinical trials with upper-limb body structure/function or activity limitation outcome measures were included.  Subgroup analyses were carried out according to phase post-stroke, device characteristics (i.e., arm support, joints involved, unimanual or bimanual training), NIBS paradigm, timing of stimulation, and number of sessions.  The Grade-Pro Software was used to assess quality of the evidence.  A non-significant homogeneous summary effect size was found both for body structure function domain (MD = 0.15; 95 % CI: -3.10 to 3.40; p = 0.93; I2 = 0 %) and activity limitation domain (standard MD [SMD] = 0.03; 95%  CI: -0.28 to 0.33; p = 0.87; I2 = 0 %).  The authors concluded that according to this systematic review and meta-analysis, there are not enough data regarding the benefits of NIBS as an add-on intervention to robot-assisted therapy on upper-limb motor function or activity in individuals with stroke.

Morone et al (2021) noted that upper limb motor impairment is one of the most frequent stroke consequences.  Robot therapy may represent an option for upper limb stroke rehabilitation; however, there are still gaps between research evidence and their use in clinical practice.  In a systematic review, these researchers examined the quality, scope, and consistency of guidelines clinical practice recommendations for upper limb robotic rehabilitation in stroke populations.  They searched for guideline recommendations on stroke published between January 1, 2010 and January 1, 2020.  Only the most recent guidelines for writing group were selected.  Electronic databases (n = 4), guideline repertories and professional rehabilitation networks (n = 12) were searched.  These investigators systematically reviewed and evaluated guidelines containing recommendation statements about upper limb robotic rehabilitation for adults with stroke.  A total of 4 independent reviewers used the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument, and textual syntheses were used to appraise and compare recommendations.  From 1,324 papers that were screened, 8 eligible guidelines were identified from 6 different regions/countries.  Half of the included guidelines focused on stroke management, the other half on stroke rehabilitation.  Rehabilitation aided by robotic devices is generally recommended to improve upper limb motor function and strength.  The exact characteristics of patients who could benefit from this treatment as well as the correct timing to use it are unknown.  The authors concluded that despite the increasing evidence of robotics effectiveness on upper limb strength and motor function, guidelines need to be improved, especially in the fields of applicability and in particular should clarify the selected patient subgroup that could benefit from robotic devices as well as the optimal time window and dose of this therapeutic approach.  These investigators stated that future research should focus on the robotic treatment measures among a general specific guidance on assessment of the upper limb measures.

Baniqued et al (2021) stated that hand rehabilitation is important in helping stroke survivors regain ADL.  Recent studies have suggested that the use of electroencephalography (EEG)-based brain-computer interfaces (BCI) can promote this process.  These investigators reported the 1st systematic examination of the literature on the use of BCI-robot systems for the rehabilitation of fine motor skills associated with hand movement and profiled these systems from a technical and clinical perspective.  These investigators carried out searches for articles (January 2010 to October 2019) using Ovid Medline, Embase, PEDro, PsycINFO, IEEE Xplore and Cochrane Library databases.  The selection criteria included BCI-hand robotic systems for rehabilitation at different stages of development involving tests on healthy subjects or individuals who have had a stroke.  Data fields included those related to study design, participant characteristics, technical specifications of the system, and clinical outcome measures.  A total of 30 studies were identified as eligible for qualitative review and among these, 11 studies involved testing a BCI-hand robot on chronic and subacute stroke patients.  Statistically significant improvements in motor assessment scores relative to controls were observed for 3 BCI-hand robot interventions.  The degree of robot control for the majority of studies was limited to triggering the device to perform grasping or pinching movements using motor imagery.  Most employed a combination of kinesthetic and visual response via the robotic device and display screen, respectively, to match feedback to motor imagery.  The authors concluded that 19 out of 30 studies on BCI-robotic systems for hand rehabilitation reported systems at prototype or pre-clinical stages of development.  These researchers identified large heterogeneity in reporting and emphasized the need to develop a standard protocol for evaluating technical and clinical outcomes so that the necessary evidence based on efficiency and efficacy can be developed.

Robotic-Assisted Rehabilitation for Traumatic Brain Injury

Meyer-Heim et al (2007) stated that intensive, task-specific training enabled by a driven gait orthosis (DGO) may be a cost-effective means of improving walking performance in children.  A pediatric DGO has recently been developed.  This study was the first pediatric trial aimed to determine the feasibility of robotic-assisted treadmill training in children with central gait impairment (n = 26; 11 females, 15 males; mean age of 10 years 1 month [SD 4 years]; range of 5 years 2 months to 19 years 5 months).  Diagnoses of the study group included cerebral palsy (n = 19; Gross Motor Function Classification System Levels I-IV), traumatic brain injury (TBI, n = 1), Guillain-Barre syndrome (n = 2), incomplete paraplegia (n = 2), and hemorrhagic shock (n = 1), and encephalopathy (n = 1); 16 children were in-patients and 10 were outpatients.  Twenty-four of the 26 patients completed the training which consisted of a mean of 19 sessions (SD 2.2; range of 13 to 21) in the in-patient group and 12 sessions (SD 1.0; range of 10 to 13) in the outpatient group.  Gait speed and 6MinWT increased significantly (p < 0.01).  Functional Ambulation Categories and Standing dimension (in-patient group p < 0.01; outpatient group p < 0.05) of the Gross Motor Function Measure improved significantly.  The authors concluded that DGO training was successfully integrated into the rehabilitation program and findings suggested an improvement of locomotor performance.  Thee preliminary findings need to be validated by well-designed studies.

Sacco and colleagues (2011) stated that it has been demonstrated that automated locomotor training can improve walking capabilities in SCI subjects but its effectiveness on brain damaged patients has not been well-established.  A possible explanation of the discordant results on the effectiveness of robotic training in patients with cerebral lesions could be that these patients, besides stimulation of physiological motor patterns through passive leg movements, also need to train the cognitive aspects of motor control.  Indeed, another way to stimulate cerebral motor areas in paretic patients is to use the cognitive function of motor imagery.  A promising possibility is thus to combine sensorimotor training with the use of motor imagery.  These researchers evaluated changes in brain activations after a combined sensorimotor and cognitive training for gait rehabilitation.  The protocol consisted of the integrated use of a robotic gait orthosis prototype with locomotor imagery tasks.  Assessment was conducted on 2 patients with chronic TBI and major gait impairments, using functional magnetic resonance imaging.  Psychiatric functional scales were used to assess clinical outcomes.  Results showed greater activation post-training in the sensorimotor and supplementary motor cortices, as well as enhanced functional connectivity within the motor network.  Improvements in balance and, to a lesser extent, in gait outcomes were also found.  The authors concluded that concluded that "Our robotic and cognitive gait rehabilitation (RCGR) protocol appears to be a useful tool for gait rehabilitation in TBI patients, whose primary impact is on balance impairment.  It may enhance both the subcortical motor automatisms and the cortical processes of motor learning.  Systematic studies involving a greater number of participants and follow-up assessments are necessary in order to confirm our suggestions".

In a review on "Efficacy of rehabilitation robotics for walking training in neurological disorders", Tefertiller et al (2011) stated that "The evidence in TBI and PD [Parkinson’s disease] is insufficient to suggest the use of locomotor training with robotic assistance is of benefit in these populations".

In a randomized, prospective study, Esquenazi et al (2013) compared the effects of robotic-assisted treadmill training (RATT) and manually assisted treadmill training (MATT) in participants with TBI and determined the potential impact on the symmetry of temporal walking parameters, 6MinWT, and the mobility domain of the Stroke Impact Scale, version 3.0 (SIS).  A total of 16 participants with TBI and a baseline over ground walking self-selected velocity (SSV) of greater than or equal to 0.2 m/s to 0.6 m/s were randomly assigned to either the RATT or MATT group.  Participant received gait training for 45 minutes, 3 times a week with either RATT or MATT for a total of 18 training sessions.  Primary outcome measures were over-ground walking SSV, maximal velocity.  Secondary outcome measures were spatio-temporal symmetry, 6MinWT, and SIS.  Between-group differences were not statistically significant for any measure.  However, from pre-training to post-training, the average SSV increased by 49.8 % for the RATT group (p = 0.01) and by 31 % for MATT group (p = 0.06).  The average maximal velocity increased by 14.9 % for the RATT group (p = 0.06) and by 30.8 % for the MATT group (p = 0.01).  Less staffing and effort was needed for RATT in this study.  Step-length asymmetry ratio improved during SSV by 33.1 % for the RATT group (p = 0.01) and by 9.1 % for the MATT group (p = 0.73).  The distance walked increased by 11.7 % for the robotic group (p = 0.21) and by 19.3 % for manual group (p = 0.03).  A statistically significant improvement in the mobility domain of the SIS was found for both groups (p ≤ 0.03).  The authors concluded that the results of this study demonstrated greater improvement in symmetry of gait (step length) for RATT and no significant differences between RATT and MATT with regard to improvement in gait velocity, endurance, and SIS.  They stated that the findings of this study provided evidence that participants with a chronic TBI can experience improvements in gait parameters with gait training with either MATT or RATT.

1. the experimental group, which received combined HEP and HMP for 3 hours/day × 5 days × 8 weeks, or
2. the control group, which received HEP only at an identical dosage. 

Weekly communication between the supervising therapist and participant promoted compliance and progression of the HEP and HMP prescription.  The Action Research Arm Test and Wolf Motor Function Test along with the Fugl-Meyer Assessment (UE) were primary and secondary outcome measures, respectively, undertaken before and after the interventions.  Both groups demonstrated improvement across all UE outcomes.  The authors concluded that robotic + HEP and HEP only were both effectively delivered remotely.  There was no difference between groups in change in motor function over time.  They stated that additional research is needed to determine the appropriate dosage of HMP and HEP.

In a prospective, open, blinded end-point, randomized, multi-center exploratory clinical trial, Takahashi et al (2016) assessed the effectiveness of robotic therapy as an adjuvant to standard therapy during post-stroke rehabilitation. A total of 60 individuals with mild-to-moderate hemiplegia 4 to 8 weeks post-stroke were randomized to receive standard therapy plus 40 minutes of either robotic or self-guided therapy for 6 weeks (7 days/week); UE impairment before and after intervention was measured using the Fugl-Meyer assessment, Wolf Motor Function Test, and Motor Activity Log.  Robotic therapy significantly improved Fugl-Meyer assessment flexor synergy (2.1 ± 2.7 versus -0.1 ± 2.4; p < 0.01) and proximal UE (4.8 ± 5.0 versus 1.9 ± 5.5; p < 0.05) compared with self-guided therapy.  No significant changes in Wolf Motor Function Test or Motor Activity Log were observed.  Robotic therapy also significantly improved Fugl-Meyer assessment proximal UE among low-functioning patients (baseline Fugl-Meyer assessment score of less than 30) and among patients with Wolf Motor Function Test greater than or equal to 120 at baseline compared with self-guided therapy (p < 0.05 for both).  The authors concluded that robotic therapy as an adjuvant to standard rehabilitation may improve UE recovery in moderately impaired post-stroke patients.  However, they stated that results of this exploratory study should be interpreted with caution.

In a RCT, Taveggia et al (2016) evaluated the effectiveness of robotic-assisted motion and activity in additional to Physical and Rehabilitation Medicine (PRM), of the upper limb in post-stroke inpatients. A total of 54 patients (57 % female, mean ± SD age of 71 ± 12 years), with upper limb function deficit post-stroke were included in this study.  The experimental group received a passive mobilization of the upper limb through the robotic device ARMEO Spring and the control group received PRM for 6 consecutive weeks (5 days/week) in addition to traditional PRM.  These investigators evaluated the impact on functional recovery (Functional Independence Measure-FIM scale), strength (ARM Motricity Index [MI]), spasticity (Modified Ashworth Scale [MAS]) and pain (Numeric Rating Pain Scale [NRPS]).  All patients were evaluated by a blinded observer using the outcomes tests at enrollment (T0), after the treatment (T1) and at follow-up 6 weeks later (T2).  Both control and experimental groups evidenced an improvement of the outcomes after the treatment (MI, MAS and NRPS with p < 0.05).  The experimental group showed further improvements after the follow-up (all outcomes with p < 0.01).  The authors concluded that in the treatment of pain, disability and spasticity in upper limb post-stroke, robot-assisted mobilization associated to PRM is as effective as traditional rehabilitation.  The main drawbacks of this study were its relatively small sample size and short-term follow-up.  These findings need to be validated by further research.

Pirondini et al (2016) noted that exoskeletons for lower and upper extremities have been introduced in neuro-rehabilitation because they can guide the patient's limb following its anatomy, covering many degrees of freedom and most of its natural workspace, and allowing the control of the articular joints. These researchers evaluated the possible use of a novel exoskeleton, the Arm Light Exoskeleton (ALEx), for robot-aided neuro-rehabilitation and examined the effects of some rehabilitative strategies adopted in robot-assisted training.  They studied movement execution and muscle activities of 16 upper limb muscles in 6 healthy subjects, focusing on end-effector and joint kinematics, muscle synergies, and spinal maps.  The subjects performed three dimensional (3D) point-to-point reaching movements, without and with the exoskeleton in different assistive modalities and control strategies.  The results showed that ALEx supported the upper limb in all modalities and control strategies: it reduced the muscular activity of the shoulder's abductors and it increased the activity of the elbow flexors.  The different assistive modalities favored kinematics and muscle coordination similar to natural movements, but the muscle activity during the movements assisted by the exoskeleton was reduced with respect to the movements actively performed by the subjects.  Moreover, natural trajectories recorded from the movements actively performed by the subjects seemed to promote an activity of muscles and spinal circuitries more similar to the natural one.  The authors concluded that the preliminary analysis on healthy subjects supported the use of ALEx for post-stroke upper limb robotic-assisted rehabilitation, and it provided clues on the effects of different rehabilitative strategies on movement and muscle coordination.

Morone and associates (2016) noted that patients affected by mild stroke benefit more from physiological over-ground walking training than walking-like training performed in place using specific devices.  These researchers evaluated the effects of over-ground robotic walking training performed with the servo-assistive robotic rollator (i-Walker) on walking, balance, gait stability and falls in a community setting in patients with mild subacute stroke.  A total of 44 patients were randomly assigned to 2 different groups that received the same therapy in 2 daily 40-min sessions 5 days a week for 4 weeks; 20 sessions of standard therapy were performed by both groups.  In the other 20 sessions the subjects enrolled in the i-Walker-Group (iWG) performed with the i-Walker and the Control-Group patients (CG) performed the same amount of conventional walking oriented therapy.  Clinical and instrumented gait assessments were made pre- and post-treatment.  The follow-up observation consisted of recording the number of fallers in the community setting after 6 months.  Treatment effectiveness was higher in the iWG group in terms of balance improvement (Tinetti: 68.4 ± 27.6 % versus 48.1 ± 33.9 %, p = 0.033) and 10-meter and 6-min timed walking tests (significant interaction between group and time: F(1,40) = 14.252, p = 0.001; and F(1,40) = 7.883, p = 0.008, respectively).  When measured, latero-lateral upper body accelerations were reduced in iWG (F = 4.727, p = 0.036), suggesting increased gait stability, which was supported by a reduced number of falls at home.  The authors concluded that a robotic servo-assisted i-Walker improved walking performance and balance in patients affected by mild/moderate stroke, leading to increased gait stability and reduced falls in the community.

The authors stated that 2 main limitations were that the study was registered only after the end of data collection and that the follow-up assessment was limited to records concerning falls and no clinical or instrumental tool was used to assess balance and walking capabilities.  Further, the number of falls was self-reported by patients; therefore, it was conceivable that subjects under-reported the incidence of falls.  Another drawback was that it was unclear whether the improvements obtained using the i-Walker could also have been achieved by the control group if their training had been performed in more variable contexts.  In any case, this would have been very difficult to obtain because it would have involved greater effort on the part of the physiotherapist (or the intervention of more than 1 therapist) and could have led to safety problems related to patients’ falling (or fear of falling).  The authors stated that future research should evaluate the effect of the i-Walker in a larger sample and should include a follow-up group; it would be useful to explore the usefulness of the i-Walker as an assistive device for use in the home.

Lehman and colleagues (2017) stated that RAGT affords an opportunity to increase walking practice with mechanical assistance from robotic devices, rather than therapists, where the child may not be able to generate a sufficient or correct motion with enough repetitions to promote improvement.  However the devices are expensive and clinicians and families need to understand if the approach is worthwhile for their children, and how it may be best delivered.  These researchers appraised the existing evidence for the effectiveness of RAGT for pediatric gait disorders, including modes of delivery and potential benefit.  A total of 6 databases were searched from 1980 to October 2016, using relevant search terms.  Any clinical trial that evaluated a clinical aspect of RAGT for children/adolescents with altered gait was selected for inclusion.  Data were extracted following the PRISMA approach.  A total of 17 trials were identified, assessed for level of evidence and risk of bias, and appropriate data extracted for reporting; 3 RCTs were identified, with the remainder of lower level design.  Most individual trials reported some positive benefits for RAGT with children with CP, on activity parameters such as standing ability, walking speed and distance.  However a meta-analysis of the 2 eligible RCTs did not confirm this finding (p = 0.72).  Training schedules were highly variable in duration and frequency and adverse events (AEs) were either not reported or were minimal.  There was a paucity of evidence for diagnoses other than CP.  The authors concluded that there is weak and inconsistent evidence regarding the use of RAGT for children with gait disorders.  If clinicians (and their clients) choose to use RAGT, they should monitor individual progress closely with appropriate outcome measures including monitoring of AEs.  They stated that further research is needed using higher level trial design, increased numbers, in specific populations and with relevant outcome measures to both confirm effectiveness and clarify training schedules.

Dierick and co-workers (2017) compared gait and posture outcome measures between ambulatory hemorrhagic patients and ischemic patients, who received a similar 4 weeks' intervention blending a conventional bottom-up physiotherapy approach and an exoskeleton top-down RAGT approach with Lokomat.  A total of 40 adult hemiparetic stroke inpatient subjects were recruited: 20 hemorrhagic and 20 ischemic, matched by age, gender, side of hemisphere lesion, stroke severity, and locomotor impairments.  Functional Ambulation Category, Postural Assessment Scale for Stroke, Tinetti Performance Oriented Mobility Assessment, 6- Minute Walk Test (6MWT), Timed Up and Go and 10-Meter Walk Test were performed before and after a 4-week long intervention.  Functional gains were calculated for all tests.  Hemorrhagic and ischemic subjects showed significant improvements in Functional Ambulation Category (p < 0.001 and p = 0.008, respectively), Postural Assessment Scale for Stroke (p < 0.001 and p = 0.003), 6MWT (p = 0.003 and p = 0.015) and 10-Meter Walk Test (p = 0.001 and p = 0.024).  Ischemic patients also showed significant improvements in Timed Up and Go.  Significantly greater mean Functional Ambulation Category and Tinetti Performance Oriented Mobility Assessment gains were observed for hemorrhagic compared to ischemic, with large (dz = 0.81) and medium (dz = 0.66) effect sizes, respectively.  The authors concluded that overall, both groups exhibited quasi similar functional improvements and benefits from the same type, length and frequency of blended conventional physiotherapy and RAGT protocol.  They stated that the use of intensive treatment plans blending top-down physiotherapy and bottom-up robotic approaches is promising for post-stroke rehabilitation.

Borboni and colleagues (2017) examined if passive robotic-assisted hand motion, in addition to standard rehabilitation, would reduce hand pain, edema, or spasticity in all patients following acute stroke, in patients with and without hand paralysis.  A total of 35 participants, aged 45 to 80 years, with functional impairments of their upper extremities after a stroke were recruited for the study from September 2013 to October 2013.  One group consisted of 16 patients (mean age ± SD of 68 ± 9 years) with full paralysis and the other groups included 14 patients (mean age ± SD of 67 ± 8 years) with partial paralysis.  Patients in the both groups used the Gloreha device for passive mobilization of the hand twice-daily for 2 consecutive weeks.  The primary outcome measure was hand edema; secondary outcome measures included pain intensity and spasticity.  All outcome measures were collected at baseline and immediately after the intervention (2 weeks).  Analysis of variance revealed that the partial paralysis group experienced a significantly greater reduction of edema at the wrist (p = 0.005) and pain (p = 0.04) when compared with the full paralysis group.  Other outcomes were similar for the groups.  The authors concluded that the findings of this study suggested that the partial paralysis group experienced a significantly greater reduction of edema at the wrist and pain when compared with the full paralysis group; however, the reduction in pain did not meet the threshold of a minimal clinically important difference.

In a systematic review, Mehrholz and associates (2017) compared the effectiveness of BWSTT and RAGT with over-ground gait training and other forms of physiotherapy in individuals with traumatic SCI.  These researchers performed an extensive search for RCTs involving people with traumatic SCI that compared either BWSTT or RAGT with over-ground gait training and other forms of physiotherapy.  The 2 outcomes of interest were walking speed (m s-1) and walking distance (m).  BWSTT and RAGT were analyzed separately, and data were pooled across trials to derive mean between-group differences using a random-effects model.  A total of 13 RCTs involving 586 people were identified; 10 trials involving 462 participants compared BWSTT to over-ground gait training and other forms of physiotherapy, but only 9 trials provided useable data.  The pooled mean (95 % CI) between-group differences for walking speed and walking distance were -0.03 m s-1 (-0.10 to 0.04) and -7 m (-45 to 31), respectively, favoring over-ground gait training; 5 trials involving 344 participants compared RAGT to over-ground gait training and other forms of physiotherapy, but only 3 provided useable data.  The pooled mean (95 % CI) between-group differences for walking speed and walking distance were -0.04 m s-1 (95 % CI: -0.21 to 0.13) and -6 m (95 % CI: -86 to 74), respectively, favoring over-ground gait training.  The authors concluded that BWSTT and RAGT did not increase walking speed more than over-ground gait training and other forms of physiotherapy did, but their effects on walking distance were unclear.

Cheung and colleagues (2017) examined the effects of robotic-assisted training on the recovery of people with SCI; RCTs or quasi-RCTs involving people with SCI that compared robotic-assisted upper limbs or lower limbs training to a control of other treatment approach or no treatment were selected for analysis.  These investigators included studies involving people with complete or incomplete SCI.  They searched in Medline, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Central Register of Controlled Trials (Cochrane Library) and Excerpta Medica dataBASE (Embase) to August, 2016.  Bibliography of relevant articles on the effect of BWSTT on SCI subjects were screened to avoid missing relevant articles from the search of databases.  All kinds of objective assessments concerning physical ability, mobility and/or functional ability were included.  Assessments could be clinical tests (namely 6MWT and Functional Independence Measure) or laboratory test (i.e., gait analysis).  Subjective outcome measures were excluded from the present review.  A total of 11 RCT studies involving 443 subjects were included in the study.  Meta-analysis was performed on the included studies.  Walking independence (3.73 with 95 % CI: -4.92 to -2.53; p < 0.00001; I2 = 38 %) and endurance (53.32 m with 95 % CI: - 73.15 to -33.48; p < 0.00001; I2 = 0 %) were found to have better improvement in robotic-assisted training groups.  Lower limb robotic-assisted training was also found to be as effective as other types of body weight supported training.  There is a lack of upper limb robotic-assisted training studies, so a meta-analysis was not possible to be performed.  The authors concluded that robotic-assisted training is an adjunct therapy for physical and functional recovery for patients with SCI.  Moreover, they stated that future high-quality studies are needed to investigate the effects of robotic-assisted training on functional and cardiopulmonary recovery of SCI patients.

Intrepid Dynamic Exoskeletal Orthosis (IDEO)

The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a customized energy storing ankle-foot orthosis (AFO) developed by the U.S. Army for individuals who have suffered massive tissue, nerve and bone damage to supposedly return capabilities to the injured ankle.  It is designed to support and protect an extensive array of lower extremity limb injuries.  The device supposedly supplies energy storage and return capabilities that an injured ankle is no longer able to provide.  Purportedly, the individual can return to a high level of activity, such as running. The IDEO device is molded out of lightweight black carbon that includes a foot plate and a strut that runs up the back of the calf to a cuff that is situated just below the knee. Reportedly, when force is applied to the foot plate, the strut bends. As the individual steps down, it bends the foot plate, transferring energy forward.
The IDEO is intended to return functionality to patients who have undergone ankle fusion procedures and to enable some patients with nerve and muscle loss to forgo ankle fusion or tendon transfer.  The IDEO is modular throughout the rehabilitation period to adapt to a patient’s changes in strength and motion.  Once the patient has progressed to an adequate level of recovery, the initial modular IDEO is replaced with a lighter, more dynamic definitive IDEO system.  Currently, there is insufficient evidence to support the clinical value of this device.

The PRIORITI-MTF Study-Testing Patient Response to the IDEO trial is currently recruiting participants.  The primary objective is to examine if a new type of custom designed brace (IDEO) along with a physical therapy program (Return to Run) improves physical function.  (Last updated November 10, 2014).
The Influence of Heel Wedge Properties on Roll-over of the Intrepid Dynamic Exoskeletal Orthosis (IDEO) is not yet open for participant recruitment.  The primary objective is to determine how heel wedge properties may contribute to the smoothness of roll-over during gait.  Insight into the effects of heel wedge properties on roll-over will help optimize the design of the IDEO-heel wedge-shoe "system" and may produce guidelines for the customization of these features.  (Last verified July 2015).

Velez-Guerrero and colleagues (2021) noted that processing and control systems based on artificial intelligence (AI) have progressively improved mobile robotic exoskeletons used in upper-limb motor rehabilitation.  In a systematic review, these investigators presented the advances and trends of those technologies.  They carried out a literature search in Scopus, IEEE Xplore, Web of Science, and PubMed using the PRISMA methodology with 3 main inclusion criteria: motor or neuromotor rehabilitation for upper limbs, mobile robotic exoskeletons, and AI.  The period under investigation spanned from 2016 to 2020, resulting in 30 articles that met the criteria.  The literature showed the use of artificial neural networks (40 %), adaptive algorithms (20 %), and other mixed AI techniques (40 %).  Furthermore, it was found that in only 16 % of the articles, developments focused on neuromotor rehabilitation.  The main trend in the research is the development of wearable robotic exoskeletons (53 %) and the fusion of data collected from multiple sensors that enriched the training of intelligent algorithms.  These researchers stated that there is a latent need to develop more reliable systems via clinical validation and improvement of technical characteristics, such as weight/dimensions of devices, in order to have positive impacts on the rehabilitation process and improve the interactions among patients, teams of health professionals, and technology.  The authors concluded that the current status of upper limb rehabilitation systems based on portable robotic exoskeletons shows that some relevant gaps should be filled in, where intelligent control and information processing systems can play key roles.  Furthermore, with the improvement of materials and the incorporation of better mechanical designs, the capabilities of exoskeletons can be largely improved.

Multiple Sclerosis

Gandolfi et al (2023) noted that UL-RAT might improve UL recovery in people with MS (PwMS) with moderate-to-severe disability.  In the few existing studies, the training effects have been related to the type of intervention, if intensive, repetitive, or task-oriented training might promote neuroplasticity and recovery.  Notably, most of these devices operate within a serious game context providing different feedback.  Since feedback is a key component of motor control; thus, entailing in motor and cognitive rehabilitation, clinicians cannot desist from considering the potential contribution of feedback in the UL-RAT effects.  In a systematic review, these investigators reported the rehabilitation protocols used in the UL-RAT in PwMS to provide state-of-the-art on the role of feedback in UL-RAT.  PubMed, the Cochrane Library, and the Physiotherapy Evidence Database databases were systematically searched from inception to March 2022.  After a literature search, the classification systems for feedback and the serious game were employed.  The authors concluded that there is a need for sharing standard definitions and components of feedback and serious game in technologically assisted UL rehabilitation.  These researchers stated that improving these aspects might further improve the effectiveness of such training in the management of PwMS.  Moreover, they noted that a greater effort should be made to the knowledge of the neuroplasticity mechanism underlying different feedback modalities.

Powered Hip Orthoses in Persons with Spinal Cord Injury

Arazpour and colleagues (2014) stated that gait training has been shown to improve the walking performance of spinal cord-injured (SCI) patients. The use of powered hip orthoses (PHO) during gait training is one approach which could potentially improve rehabilitative outcomes for such subjects. These researchers evaluated the influence of a PHO on the kinematics and temporal-spatial parameters of walking by SCI patients. The PHO used for the gait training of the volunteer SCI patients was custom made and fitted according to patient’s lower limb length, and the ankle foot orthosis portions of the orthosis were made after casting the lower extremities. The structure of orthosis and its efficacy when worn by one SCI patient has been described in a previously publication (Arazpour, et al., 2012). A total of 4 SCI patients participated in this study.  Gait evaluation was performed at baseline and at 10 weeks following intervention with the use of a PHO and gait re-training.  Walking speed, step length, vertical and horizontal compensatory motions and hip joint kinematics were analyzed prior to and following the training regime.  Significant increases in walking speed and step length were demonstrated by the SCI patients when walking with the PHO following orthotic gait training.  Sagittal plane hip range of motion also increased, but not significantly.  However, vertical and horizontal compensatory motions decreased significantly.  The authors concluded that positive effects on the kinematics and temporal-spatial parameters of gait by SCI subjects were demonstrated following a period of gait training with a PHO.  Moreover, they stated that further studies are needed to confirm their long-term effects on the rehabilitation of SCI subjects.

Arazpour and associates (2015) noted that powered orthoses are a new generation of assistive devices for people with SCI, which are designed to induce motion to paralyzed lower limb joints using external power via electric motors or pneumatic or hydraulic actuators. Powered gait orthoses provide activated movement of lower limb joints to limit the forces applied through the upper limb joints and trunk muscles during ambulation due to the need to use an external walking aid, while simultaneously improving the kinetics and kinematics of walking in subjects with SCI. These investigators reviewed the walking efficacy of powered orthoses when used by people with paraplegia.  A literature search was performed in ISI Web of Knowledge, PubMed, Google Scholar, ScienceDirect, and Scopus databases.  Efficacy was demonstrated in producing activated motion of lower limb joints.  Powered gait orthoses have a beneficial effect on the kinetics, kinematics, and temporal-spatial parameters of gait, but their effect on muscle activity in individuals with SCI is still unclear.  The authors concluded that further research is needed regarding the design and construction of powered gait orthoses using significant power application to the ankle joints and their effect on lower limb muscle activity and gait patterns in subjects with SCI.

Ahmadi Bani and co-workers (2015) stated that the most simple and common approach in providing standing and walking by subjects with SCI is the use of mechanical orthoses. These include traditional orthoses, medial linkage orthoses (MLOs) and reciprocating gait orthoses (RGOs). Independence, energy expenditure, gait parameters, system reliability and cosmesis are important factors in orthotic design.  These researchers compared the evidence of existing mechanical orthoses to that of other types regarding these factors.  The preferred reporting items for systematic reviews and meta-analyses (PRISMA) method was used by an experience researcher based on selected keywords and their composition and an electronic search was performed in well-known databases.  A total of 20 articles were selected for final evaluation.  Many were case studies, and also had limited and heterogeneous sample sizes with different instruments used for evaluation.  The results of the analysis demonstrated that independence and cosmesis were improved when using MLOs, but gait parameters, energy expenditure and stability were all improved when using RGOs.  The authors concluded that those mechanical orthoses which have reciprocal motion and congruency between the anatomical and orthotic joints have been shown to provide positive effects on patient lifestyles.  However, they stated that further improvement is needed to more effectively meet the needs of SCI patients.

Arazpour et al (2016) noted that orthoses for various joints sections are considered to greatly influence the gait function and energy expenditure in SCI patients. These investigators determined the influence of orthoses characteristics and options on the improvement of walking in patients with SCI.  They performed a search using the Population Intervention Comparison Outcome (PICO) method, based on selected keywords; studies were identified electronically in the Science Direct, Google Scholar, Scopus, Web of Knowledge and PubMed databases.  The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) method was used to report the results.  Assessment of the quality of all articles was performed based on the Physiotherapy Evidence Database (PEDro scale).  A total of 12 studies evaluated the effects of different hip joint options on walking parameters and energy expenditure; 5 studies investigated the role of knee joint options on gait parameters and compensatory trunk motion.  Only 5 studies analyzed modified ankle joints on gait parameters in SCI patients; 9 studies analyzed gait parameters in SCI patients as powered orthoses and exoskeleton.  These studies had a low level of evidence according to the PEDro score (2/10).

Spinal Cord Injuries

Singh and associates (2018) provided an overview of the feasibility and outcomes of robotic-assisted upper extremity training for individuals with cervical SCI, and to identify gaps in current research and articulate future research directions.  A systematic search was conducted using Medline, Embase, PsycINFO, CCTR, CDSR, CINAHL and PubMed on June 7, 2017.  Search terms included 3 themes: robotics; SCI; and upper extremity. Studies using robots for upper extremity rehabilitation among individuals with cervical SCI were included. Identified articles were independently reviewed by two researchers and compared to pre-specified criteria.  Disagreements regarding article inclusion were resolved through discussion.  The modified Downs and Black checklist was used to assess article quality.  Participant characteristics, study and intervention details, training outcomes, robot features, study limitations and recommendations for future studies were abstracted from included articles.  A total of 12 articles (1 randomized clinical trial, 6 case series, 5 case studies) met the inclusion criteria; 5 robots were exoskeletons and 3 were end-effectors.  Sample sizes ranged from 1 to 17 subjects.  Articles had variable quality, with quality scores ranging from 8 to 20.  Studies had a low internal validity primarily from lack of blinding or a control group.  Individuals with mild-moderate impairments showed the greatest improvements on body structure/function and performance-level measures.  This review was limited by the small number of articles, low-sample sizes and the diversity of devices and their associated training protocols, and outcome measures.  The authors concluded that preliminary evidence suggested that robot-assisted interventions are safe, feasible and can reduce active assistance provided by therapists.  Moreover, they stated that future research in robotics rehabilitation with individuals with SCI is needed to determine the optimal device and training protocol as well as effectiveness.

Hayes and colleagues (2018) systematically reviewed the literature and identify if over-ground or treadmill based RAGT use in SCI individuals elicited differences in temporal-spatial characteristics and functional outcome measures.  A systematic search of the literature investigating over-ground and treadmill RAGT in SCIs was undertaken excluding case-studies and case-series.  Studies were included if the primary outcomes were temporal-spatial gait parameters.  Study inclusion and methodological quality were assessed and determined independently by 2 reviewers.  Methodological quality was assessed using a validated scoring system for randomized and non-randomized trials.  A total of 12 studies met all inclusion criteria.  Participant numbers ranged from 5 to 130 with injury levels from C2 to T12, American Spinal Injuries Association A-D; 3 studies used over-ground RAGT systems and the remaining 9 focused on treadmill based RAGT systems.  Primary outcome measures were walking speed and walking distance.  The use of treadmill or over-ground based RAGT did not result in an increase in walking speed beyond that of conventional gait training and no studies reviewed enabled a large enough improvement to facilitate community ambulation.  The authors concluded that the use of RAGT in SCI individuals has the potential to benefit upright locomotion of SCI individuals.  Moreover, they stated that its use should not replace other therapies but be incorporated into a multi-modality rehabilitation approach.

Yozbatiran and Francisco (2019) noted that tetraplegia resulting from cervical injury is the most frequent neurologic category following SCI and causes substantial disability.  The residual strength of partially paralyzed muscles is an important determinant of independence and function in tetraplegia.  Small improvements in UE function can make a clinically significant difference in daily activities.  Major advances in rehabilitation technologies over the past 20 years have allowed testing of robotic devices in rehabilitation of motor impairments.  The authors provided an overview of robotic-assisted training research for improving arm and hand functions following cervical SCI.  They concluded that robot-assisted rehabilitation of the UE following cervical SCI is safe and feasible; but lacks sufficient evidence of clinical effectiveness.

Tarnacka et al (2023) stated that the improvement of walking ability is a primary objective for patients with SCI; and RAGT is an innovative method for its improvement.  In a single-blinded, this single-center study, these researchers examined the influence of RAGT versus dynamic parapodium training (DPT) in improving gait motor functions in SCI patients.  This trial enrolled 105 (39 and 64 with complete and incomplete SCI, respectively) patients.  The investigated subjects received gait training with RAGT (experimental S1-group) and DPT (control S0-group), with 6 training sessions/week over 7 weeks.  The American Spinal Cord Injury Association Impairment Scale Motor Score (MS), Spinal Cord Independence Measure, version-III (SCIM-III), Walking Index for Spinal Cord Injury, version-II (WISCI-II), and Barthel Index (BI) were assessed in each patient before and after sessions.  Patients with incomplete SCI assigned to the S1 rehabilitation group achieved more significant improvement in MS [2.58 (SE 1.21, p < 0.05)] and WISCI-II [3.07 (SE 1.02, p < 0.01])] scores in comparison with patients assigned to the S0 group.  Despite the described improvement in the MS motor score, no progression between grades of AIS (A to B to C to D) was observed.  A non-significant improvement between the groups for SCIM-III and BI was found.  The authors concluded that RAGT significantly improved gait functional parameters in SCI patients in comparison with conventional gait training with DPT.  RAGT is a valid therapeutic option in SCI patients in the subacute phase.  DPT should not be recommended for patients with incomplete SCI (AIS-C); in those patients, RAGT rehabilitation programs should be taken into consideration.  Moreover, these researchers stated that the observed progress in robotic-assisted neurorehabilitation is a promising gait therapy method; thus, there is a need for further research and the development of more individualized and integrated assistive technologies for functional locomotion in patients with SCI.

These investigators noted that in previous studies, the reported RAGT limitations mostly concerned the occurrence physiological gait movements, such as the abnormal sensory stimuli created by a strap used to fix the patient’s lower limbs to the robot; the decrease in muscle activities that produce stability and propulsive force; passively induced movements; the occurrence of sagittal plane lower limb movements; the lack of movements of the trunk and pelvis; or the absence of an effective weight shift .  The other study conducted by Bae et al (2021) aimed to analyze the effects of RAGT on foot pressure to determine an effective training protocol for patients with incomplete SCI.  The authors found that during robotic therapy, lower peak foot pressure and shorter stance phase duration were observed, and they concluded that this fact could limit gait pattern improvement in SCI patients undergoing robotic therapy.  However, it must be emphasized that these were preliminary studies carried out on a very small number of patients (n = 4) with low thoracic and high lumbar lesions.  In a parapodium device, patient may have active muscles, such as the erector spine, gluteus medius, biceps femoris, etc.; the patient is also able to activate proprioception.  However, parapodium has also limitations, such as the great effort required by the patient and the therapy being very monotonous for the patient, which could markedly reduce the motivation to exercise.  It is for this reason that this rehabilitation equipment is often not used, despite being purchased by the patient.  This study included patients from different parts of the authors’ country; however, it was performed in a single centre.  These researchers stated that a deeper analysis of this problem may require multi-center or international studies.  Furthermore, all participants wanted to be assigned to the RAGT group; hence, they often withdrew from continuing the study when assigned to a group without RAGT, leading to the smaller sample size of the control group.  The inclusion of these parameters may influence the findings of this study.

Stroke

Gandolfi and colleagues (2018) noted that bilateral arm training (BAT) has shown promise in expediting progress toward upper limb recovery in chronic stroke patients, but its neural correlates are poorly understood.  In a pilot study, these researchers evaluated changes in upper limb function and electroencephalographic (EEG) power after a robot-assisted BAT in chronic stroke patients.  In a within-subject design, 7 right-handed chronic stroke patients with upper limb paresis received 21 sessions (3 days/week) of the robot-assisted BAT.  The outcomes were changes in score on the upper limb section of the Fugl-Meyer assessment (FM), Motricity Index (MI), and Modified Ashworth Scale (MAS) evaluated at the baseline (T0), post-training (T1), and 1-month follow-up (T2).  Event-related desynchronization/synchronization were calculated in the upper alpha and the beta frequency ranges.  Significant improvement in all outcomes was measured over the course of the study.  Changes in FM were significant at T2, and in MAS at T1 and T2.  After training, desynchronization on the ipsilesional sensorimotor areas increased during passive and active movement, as compared with T0.  The authors concluded that a repetitive robotic-assisted BAT program may improve upper limb motor function and reduce spasticity in the chronically impaired paretic arm.  Effects on spasticity were associated with EEG changes over the ipsilesional sensorimotor network.  These researchers speculated that the reduction in spasticity may have facilitated EEG changes over the ipsilesional sensorimotor network.  They stated that the utility of a bilateral repetitive robot-assisted program as an adjuvant to physical therapy needs further consideration.

The authors stated that the main drawback of the present study was its small sample size (n = 7).  Moreover, the lack of homogeneity between brain lesion size and location would have precluded statistically significant results.  The event-related desynchronization (ERD; i.e., power band decrease)/event-related synchronization (ERS; i.e., power band increase) maps of the patients shown were different among themselves, and each map was also different with the control group in different ways.  The current results varied across patients and precluded to conclude.  According to these preliminary results, future studies would enroll larger sample size, and patients would be stratified according to lesion features.  It would allow discussing EEG power changes after specific robot-assisted upper limb training (i.e., active, passive, unilateral, and bilateral).  Other drawbacks were the lack of follow-up beyond 1 month and the lack of a control group receiving conventional therapy.  Moreover, control group should be age-matched, in order to compare it to a group of subjects affected by stroke.  However, since the peak frequency of the mu wave increased with age until maturation into adulthood, when it reached its final and stable frequency of 8 to 13 Hz, the age of the subjects should not significantly affect the EEG desynchronization process during movement.

Cho and associates (2018) evaluated the effects of RAGT on gait-related function in patients with acute/subacute stroke.  These researchers conducted a systematic review of RCTs published between May 2012 and April 2016.  This search included 334 articles (Cochrane, 51 articles; Embase, 175 articles; PubMed, 108 articles).  Based on the inclusion and exclusion criteria, 7 studies were selected for this review.  These investigators performed a quality evaluation using the PEDro scale.  In this review, 3 studies used an exoskeletal robot, and 4 studies used an end-effector robot as interventions.  As a result, RAGT was found to be effective in improving walking ability in subacute stroke patients.  Significant improvements in gait speed, functional ambulatory category, and Rivermead mobility index were found with RAGT compared with conventional physical therapy (p < 0.05).  The authors concluded that aggressive weight support and gait training at an early stage using a robotic device are helpful, and robotic intervention should be applied according to the patient's functional level and onset time of stroke.

The authors stated that the main drawback of this review was that it included a small number of studies (and subjects).  They stated that future review studies should include a qualitative analysis of the frequency and intensity of interventions, including more studies on subacute stroke patients.  In addition they stated that further studies are needed to demonstrate the effectiveness of RAGT according to the functional level of stroke patients in not only the subacute phase but also the chronic phase.

Dehem and associates (2018) stated that the impact of transcranial direct current stimulation (tDCS) is controversial in the neurorehabilitation literature.  It has been suggested that tDCS should be combined with other therapy to improve their efficacy.  In a randomized, controlled, double-blind, cross-over study, these researchers examined the effectiveness of a single-session of upper limb robotic-assisted therapy (RAT) combined with real or sham-tDCS in chronic stroke patients.  A total of 21 hemiparetic chronic stroke patients were included in this trial.  Participants underwent 2 sessions 7 days apart in a randomized order: 20-min of real dual-tDCS associated with RAT (REAL+RAT); and 20-min of sham dual-tDCS associated with RAT (SHAM+RAT).  Patient dexterity (Box and Block and Purdue Pegboard tests) and upper limb kinematics were evaluated before and just after each intervention.  The assistance provided by the robot during the intervention was also recorded.  Gross manual dexterity (1.8 ± 0.7 blocks, p = 0.008) and straightness of movement (0.01 ± 0.03, p < 0.05) improved slightly after REAL+RAT compared with before the intervention.  There was no improvement after SHAM+RAT.  The post-hoc analyses did not indicate any difference between interventions: REAL+RAT and SHAM+RAT (p > 0.05).  The assistance provided by the robot was similar during both interventions (p > 0.05).  The authors concluded that the results showed a slight improvement in hand dexterity and arm movement following the REAL+RAT tDCS intervention.  They noted that the observed effect after a single-session was small and not clinically relevant; repetitive sessions could increase the benefits of this combined approach.

Rodgers and colleagues (2019) noted that loss of arm function is a common problem following stroke.  Robot-assisted training might improve arm function and ADL. In a multi-center RCT, these researchers compared the effectiveness of robot-assisted training using the MIT-Manus robotic gym with an enhanced upper limb therapy (EULT) program based on repetitive functional task practice and with usual care.  This trial was carried out at 4 UK centers.  Stroke patients aged at least 18 years with moderate or severe upper limb functional limitation, between 1 week and 5 years after their 1st stroke, were randomly assigned (1:1:1) to receive robot-assisted training, EULT, or usual care.  Robot-assisted training and EULT were provided for 45 mins, thricely-weekly for 12 weeks.  Randomization was internet-based using permuted block sequences.  Treatment allocation was masked from outcome assessors but not from participants or therapists.  The primary outcome was upper limb function success (defined using the Action Research Arm Test [ARAT]) at 3 months.  Analyses were performed on an intention-to-treat (ITT) basis.  Between April 14, 2014, and April 30, 2018, a total of 770 participants were enrolled and randomly assigned to either robot-assisted training (n = 257), EULT (n = 259), or usual care (n = 254).  The primary outcome of ARAT success was achieved by 103 (44 %) of 232 patients in the robot-assisted training group, 118 (50 %) of 234 in the EULT group, and 85 (42 %) of 203 in the usual care group.  Compared with usual care, robot-assisted training (adjusted OR [aOR] 1.17 [98.3 % CI: 0.70 to 1.96]) and EULT (aOR 1.51 [0.90 to 2.51]) did not improve upper limb function; the effects of robot-assisted training did not differ from EULT (aOR 0.78 [0.48 to 1.27]).  More participants in the robot-assisted training group (39 [15 %] of 257) and EULT group (33 [13 %] of 259) had serious AEs than in the usual care group (20 [8 %] of 254), but none was attributable to the intervention.  The authors concluded that robot-assisted training and EULT did not improve upper limb function following stroke compared with usual care for patients with moderate or severe upper limb functional limitation.  These researchers stated that these findings did not support the use of robot-assisted training as provided in this trial in routine clinical practice.

In a meta-analysis, Zhang et al (2022) examined the effect of RAT on UL motor control and activity function in post-stroke patients compared with that of non-robotic therapy.  These investigators searched PubMed, Embase, Cochrane Library, Google Scholar and Scopus; RCTs published from 2010 to present comparing the effect of RAT and control treatment on UL function of post-stroke patients aged 18 years or older were included.  Researchers extracted all relevant data from the included studies, assessed the heterogeneity with inconsistency statistics (I2 statistics), examined the risk of bias of individual studies and carried out data analysis.  A total of 46 studies were included.  Meta-analysis showed that the outcome of the Fugl-Meyer Upper Extremity assessment (FM-UE) (SMD = 0.20, p = 0.001) and activity function post-intervention was significantly higher (SMD = 0.32, p < 0.001) in the RAT group than in the control group.  Differences in outcomes of the FM-UE and activity function between the RAT group and control group were observed at the end of treatment and were not found at the follow-up.  Furthermore, the outcomes of the FM-UE (SMD = 0.15, p = 0.005) and activity function (SMD = 0.32, p = 0.002) were significantly different between the RAT and control groups only with a total training time of more than 15 hours.  Moreover, the differences in outcomes of FM-UE and activity post-intervention were not significant when the arm robots were applied to patients with severe impairments (FM-UE: SMD = 0.14, p = 0.08; activity: SMD = 0.21, p = 0.06) or when patients were provided with patient-passive training (FM-UE: SMD = - 0.09, p = 0.85; activity: SMD = 0.70, p = 0.16).  The authors concluded that RAT has the significant immediate benefits for motor control and activity function of hemiparetic UL in patients following stroke compared with controls; however, there is no evidence to support its long-term additional benefits.  These researchers stated that the superiority of RAT in improving motor control and activity function is limited by the amount of training time and the patients' active participation.  Moreover, these researchers stated that considering the application of arm robot, the number of repetitions, the frequency and the duration of robot-assisted training may also influence the effectiveness of RAT, future study should stratify the patients according to those factors to further determine the optimal application and parameters of RAT.

The authors stated that this meta-analysis had several drawbacks.  First, the use of arm robot such as arm robot alone or RAT combined with controls may affect the differences in outcomes of motor control and activity between intervention and control group; however, these researchers have not further discussed this factor. Second, these investigators only examined the effect of total training time on effectiveness of RAT; however, other parameters such as the number of repetitions, frequency and duration of RAT also influence its effect.  Third, the small sample size in follow-up group may result in these findings being under-powered.

Mazzucchelli et al (2022) noted that the recovery of walking following stroke is a key objective for recovering autonomy.  In the last years robotic systems employed for RAGT were developed.  However, literature and clinical practice did not offer standardized RAGT protocol or pattern of evaluation scales.  In a systematic review, these investigators examined the available evidence on the use of RAGT in post-stroke, following the CICERONE Consensus indications.  The literature search was carried out on PubMed, Cochrane Library and PEDro, including studies with the following criteria: adult post-stroke survivors with gait disability in acute/subacute/chronic phase; RAGT as intervention;  any comparators; outcome regarding impairment, activity, and participation; both primary studies and reviews.  A total of 61 studies were selected.  Data on characteristics of patients, level of disability, robotic devices used, RAGT protocols, outcome measures, and level of evidence were extracted.  The authors concluded that it is possible to identify robotic devices that are more suitable for specific phase disease and level of disability; however, these researchers identified significant variability in dose and protocols; RAGT as an add-on treatment appeared to be prevalent.  Moreover, these investigators stated that further studies are needed to examine the outcomes achieved as a function of RAGT doses delivered.

Pournajaf et al (2023) noted that the effectiveness of UL-RAT on functional improvement following stroke remains unclear; however, recently published RCTs have supported its potential benefits in enhancing the ADL, arm and hand function, as well as muscle strength.  Task-specific and high-intensity exercises are key points in facilitating motor re-learning in neurorehabilitation since RAT can provide an assisted-as-needed approach.  This study aims to examine the clinical effects of an exoskeleton robotic system for UL rehabilitation compared with conventional therapy (CT) in individuals with subacute stroke.  As a secondary aim, these investigators seek to identify patients' characteristics, which can predict better recovery following UL-RAT and detects whether it could elicit greater brain stimulation.  A total of 84 subacute stroke patients will be recruited from 7 Italian rehabilitation centers over 3 years.  Subjects will be randomly allocated to either CT (control group, CG) or CT plus UL-RT via an ArmeoPower exoskeleton (experimental group, EG).  A sample stratification based on distance since onset, DSO (DSO of less than or equal to 30; DSO of greater than 30), and Fugl-Meyer Assessment (FM)-UL (FM-UL ≤ 22; 22 < FM-UL ≤ 44) will be considered for the randomization. The outcomes will be recorded at baseline (T0), after 25 + 3 sessions of intervention (T1), and at 6 months post-stroke (T2). The motor functioning assessed by the FM-UL (0-66) will be considered the primary outcome.  The clinical assessments will be set based on the International Classification of Function, Disability and Health (ICF).  A patient satisfaction questionnaire will be evaluated in the EG at T1.  A subgroup of subjects will be examined at T0 and T1 via EEG.  Their brain electrical activity will be recorded during rest conditions with their eyes closed and open (5 mins each).  The authors concluded that the findings of this RCT might shed some light onto the real effectiveness of UL-RAT in patients with stroke, as compared with conventional treatments.  Since it will examine the neurophysiological basis underpinning functional recovery using a combined surface EMG (sEMG)-EEG approach, the results could be useful in justifying a wider use of exoskeletons in clinical practice.

The authors stated that this protocol has 2 main limitations.  First, spontaneous recovery will be the main determinant for the trajectories of the obtained recovery; thus, it will be difficult to separate the observed time-dependent changes over time, discriminating how much they are due to biological processes or the rehabilitation interventions and environments.  To overcome this specific issue, a stratification for time since stroke has been planned.  Second, the neurophysiological and kinematic assessment will be carried out in a subgroup of patients, preventing these researchers from drawing definite conclusions on the differences among treatments on the brain dynamics and quality of arm movements.

Bressi et al (2023) stated that robotic therapy allows to propose sessions of controlled and identical exercises, customizing settings, and characteristics on the individual patient.  The effectiveness of RAT is still under study and the use of robots in clinical practice is still limited.  Moreover, the possibility of treatment at home allows to reduce the economic costs and time to be borne by the patient and the caregiver and is a valid tool during periods of pandemic such as COVID.  In a pilot study, these researchers examined if a robotic home-based treatment rehabilitation using the iCONE robotic device would have effects on a stroke population, despite the chronic condition of patients involved and the absence of a therapist next to the patient while performing the exercises.  All patients underwent an initial (T0) and final (T1) assessment with the iCONE robotic device and clinical scales.  After T0 evaluation, the robot was delivered to the patient's home for 10 days of at-home treatment (5 days/week for 2 weeks).  Comparison between T0 and T1 evaluations showed some significant improvements in robot-evaluated indices such as Independence and Size for the Circle Drawing exercise and Movement Duration for Point-to-Point exercise, but also in the MAS of the elbow.  From the analysis of the acceptability questionnaire, a general appreciation of the robot emerged: patients spontaneously asked for the addition of further sessions and to continue therapy.  Tele-rehabilitation of patients suffering from a chronic stroke is an area that is still little explored.  From their experience, this was one of the first studies to perform a tele-rehabilitation with these characteristics.  The use of robots could become a method to reduce the rehabilitation health costs, to ensure continuity of care, and to arrive in more distant places or where the availability of resources is limited.   The authors concluded that from the data obtained, this rehabilitation appeared to be promising for this population.  Moreover, promoting the recovery of the UL, iCONE can improve patient's QOL. It would be interesting to carry out RCT studies to compare a conventional treatment in structure with a robotic telematics treatment.  Moreover, these researchers stated that these findings were promising for this type of rehabilitation, so it would be interesting to continue the study on a larger sample, providing a longer therapy time and inserting a control group.  The study presented was a pilot study, without control group, so the results obtained should be considered as preliminary data and should be confirmed with better structured studies, such as RCTs.  They stated that it would also be useful to re-examine the patient to follow-up, to see if the results obtained are kept even at time from the use of the robot.

Faulkner et al (2023) noted that overground RAGT (O-RAGT) has been shown to improve clinical functional outcomes in individuals with stroke.  These researchers examined if a home-based O-RAGT program, in combination with usual care physiotherapy, would demonstrate improvements in vascular health in individuals with chronic stroke, and, whether any changes in vascular outcomes would be sustained 3 months after completing the program.  A total of 34 subjects with chronic stroke (between 3 months and 5 years post-stroke) were randomized to either a 10-week O-RAGT program in combination with usual care physiotherapy, or to a usual care physiotherapy only control group.  Subjects' (n = 31) pulse wave analysis (PWA), and regional [carotid-femoral pulse wave analysis (cfPWV)] and local (carotid) measures of arterial stiffness were assessed at baseline, post-intervention, and 3-month post-intervention.  Analysis of covariance showed a significant reduction (improvement) in cfPWV between BL and PI for O-RAGT (8.81 ± 2.51 versus 7.92 ± 2.17 m/s, respectively), whilst the control group remained unchanged (9.87 ± 2.46 versus 9.84 ± 1.76 m/s, respectively; p < 0.05; ηp2 = 0.14).  The improvement in cfPWV was maintained 3 months after completing the O-RAGT program.  There were no significant Condition by Time interactions for all PWA and carotid arterial stiffness measures (p > 0.05).  A significant increase in physical activity, as determined by the time spent stepping, was observed for O-RAGT between baseline and post-intervention assessments (3.2 ± 3.0 % to 5.2 ± 3.3 %, respectively) but not for CON (p < 0.05).  The improvement in cfPWV, in combination with an increase in physical activity while wearing the O-RAGT and concomitant reduction in sedentary behavior, are important positive findings when considering the use of this technology for "at home" rehabilitation therapy for stroke survivors.  These investigators stated that further, larger RCTs are needed to examine if implementing "at home" O-RAGT programs should be a part of the stroke treatment pathway.

The authors stated that this study had several drawbacks.  First, the small sample size (n = 31) was determined based on a primary outcome measure that was not a focus in this study (6-min walk test); however, an a priori sample size calculation based on the cfPWV reported between groups at PI demonstrated that a sufficient sample size was recruited (n = 13 per group).  Second, regional (cfPWV) and local (carotid) measures of arterial stiffness were only examined on participants' left side.  As the stroke diagnosis (and hemisphere affected) varied between participants, the assessment of regional and local stiffness measures on both the right and left side may have been informative, especially for those participants for whom the right carotid artery may have been symptomatic.  Third, participants were recruited from an independent neuro-physiotherapy practice thar could be a determining factor to whether a home-based program is successful.  The selected population were likely to be highly motivated to engage in rehabilitation due to the costs associated with engaging in physiotherapy with an independent provider.  The total dosage of physical activity in the O-RAGT condition was likely higher than the control condition and could have also been a reason for the observed findings.  Finally, findings should be interpreted with caution as multiple analyses inflate the risk of type I error, while researchers responsible for collecting outcome data were not blinded to group allocation.

Humeral Fracture

Nerz and colleagues (2017) noted that the incidence of proximal humeral fractures (PHFs) increases with age.  The functional recovery of the upper arm after such fractures is slow, and results are often disappointing.  Treatment of PHF is associated with long immobilization periods.  Evidence-based exercise guidelines are missing.  Loss of muscle mass as well as reduced ROM and motor performance are common consequences.  These losses could be partly counteracted by training interventions using robot-assisted arm support of the affected arm derived from neurorehabilitation.  Thus, shorter immobilization could be reached; however, this approach has been tested in only a few small studies.  These researchers examined if assistive robotic training augmenting conventional occupational and physical therapy can improve functional shoulder outcomes.  Patients aged between 35 and 66 years with PHF and surgical treatment will be recruited at 3 different clinics in Germany and randomized into an intervention group and a control group (n = 26 for each group).  Participants will be assessed before randomization and followed after completing an intervention period of 3 weeks and additionally after 3, 6 and 12 months.  The baseline assessment will include cognition (Short Orientation-Memory-Concentration Test); level of pain in the affected arm; ability to work; gait speed (10-m walk); disability of the arm, shoulder and hand (Disabilities of the Arm, Shoulder and Hand Outcome Measure [DASH]); ROM of the affected arm (goniometer measurement); visual acuity; and motor function of orthopedic patients (Wolf Motor Function Test–Orthopedic version [WMFT-O]).  Clinical follow-up directly after the intervention will include assessment of DASH as well as ROM and motor function (WMFT-O).  The primary outcome parameter will be the DASH, and the secondary outcome parameter will be the WMFT-O.  The long-term results will be assessed prospectively by postal follow-up.  All patients will receive conventional occupational and physical therapy.  The intervention group will receive additional robot-assisted training using the Armeo®Spring robot for 3 weeks.  The authors concluded that this study protocol describes a phase-II, randomized, controlled, single-blind, multi-center intervention study.  The results will guide and possibly improve methods of rehabilitation after proximal humeral fracture.

The authors stated that this trial/protocol have several limitations: First, the sample size is relatively small (n = 26 for each group) and powered only for a functional end-point (DASH).  Social or economic end-points such as return to work or cost-effectiveness of this intervention would require larger sample sizes and is not the purpose of this early-stage RCT.  Second, the set-up with 3 different associated centers will lead to some difficulties in the standardization of the assessments.  It is expected that different observers and therapists in the 3 institutions have subjective differences in the accomplishment of the tests.  Assessment of the WMFT will be videotaped to standardize this as much as possible.  Lastly, heterogeneous treatment modalities will also exist to some extent for rehabilitation after PHF in the conventional occupational and physical therapy in terms of duration, intensity and frequency. Theoretically, participation in the robotic group could lead to increased or decreased motivation to participate in other types of exercises. Adherence will therefore be documented.

Furthermore, UpToDate reviews on "Proximal humeral fractures in adults" (Bassett, 2018a), "Midshaft humeral fractures in adults" (Bassett , 2018b), "Proximal humeral fractures in children" (Ryan, 2018a), and "Midshaft humeral fractures in children" (Ryan, 2018b) do not mention robotic-assisted rehabilitation as a management option.

Myoelectric Elbow-Wrist-Hand Orthosis

In an observational, cohort study, Peters and colleagues (2017) determined the immediate effect of a portable, myoelectric elbow-wrist-hand orthosis (MEWHO) on paretic UE impairment in chronic, stable, moderately impaired stroke survivors (n = 18).  Participants were administered a battery of measures testing UE impairment and function.  They then donned a fabricated MEWHO and were again tested on the same battery of measures while wearing the device.  The primary outcome measure was the UE Section of the Fugl-Meyer Scale.  Subjects were also administered a battery of functional tasks and the Box and Block (BB) test.  Subjects exhibited significantly reduced UE impairment while wearing the MEWHO (FM: t17 = 8.56, p < 0.0001) and increased quality in performing all functional tasks while wearing the MEWHO, with 3 sub-tasks showing significant increases (feeding [grasp]: z = 2.251, p = 0.024; feeding [elbow]: z = 2.966, p = 0.003; drinking [grasp]: z = 3.187, p = 0.001).  Additionally, subjects showed significant decreases in time taken to grasp a cup (z = 1.286, p = 0.016) and increased gross manual dexterity while wearing a MEWHO (BB test: z = 3.42, p < 0.001).  The authors concluded that findings of this study suggested that UE impairment, as measured by the Fugl-Meyer Scale, was significantly reduced when donning a MEWHO, and these changes exceeded the Fugl-Meyer Scale's clinically important difference threshold.  Furthermore, utilization of a MEWHO significantly increased gross manual dexterity and performance of certain functional tasks.  These researchers stated that future work will integrate education sessions to increase subjects' ability to perform multi-joint functional movements and attain consistent functional changes.  The authors noted that this was the first study comparing subjects with and without a MEWHO.  Well-designed studies with large sample sizes and control groups are needed.

Dunaway and associates (2017) described the application of a commercially available, custom MEWHO, on a veteran diagnosed with chronic stroke with residual left hemiparesis.  The MEWHO provides powered active assistance for elbow flexion/extension and 3 jaw chuck grip.  It is a non-invasive orthosis that is driven by the user's EMG signal.  Experience with the MEWHO and associated outcomes were reported.  The participant completed 21 out-patient occupational therapy sessions that incorporated the use of a custom MEWHO without grasp capability into traditional occupational therapy interventions.  He then up-graded to an advanced version of that MEWHO that incorporated grasp capability and completed an additional 14 sessions.  Strength, ROM, spasticity (MAS), the BB test, the Fugl-Meyer assessment and observation of functional tasks were used to track progress.  The participant also completed a home log and a manufacturers' survey to track usage and user satisfaction over a 6-month period.  Active left UE ROM and strength increased significantly (both with and without the MEWHO) and tone decreased, demonstrating both a training and an assistive effect.  The participant also demonstrated an improved ability to incorporate his affected extremity (with the MEWHO) into a wide variety of bilateral, gross motor ADLs such as carrying a laundry basket, lifting heavy objects (e.g., a chair), using a tape measure, meal preparation, and opening doors.  The authors concluded that custom myoelectric orthoses offer an exciting opportunity for individuals diagnosed with a variety of neurological conditions to make advancements toward their recovery and independence, and warrant further research into their training effects as well as their use as assistive devices.

Myomo MyoPro

Webber et al (2021) noted that individuals with brachial plexus injuries (BPIs) can be prescribed assistive devices, including myoelectric elbow orthoses (MEOs), for rehabilitation or functional use after failed treatment for elbow flexion restoration.  Although recent case studies indicate potential for clinical improvements following the use of an MEO after BPI, patients' perspectives on such use are still unknown.  In a study using both a focus group and semi-structured interviews, these investigators examined patient perspectives on the use of an MEO following surgical treatment for a traumatic BPI.  Patients with BPI who used an MEO were recruited.  A total of 5 patients participated in an in-person focus group, whereas 3 patients participated in individual phone interviews.  Themes that emerged from the focus group were compared against those that emerged from the personal interviews.  Feedback was grouped into 3 themes: device usage, hardware performance, and device design.  Within each theme, positive elements, areas for improvement, and additional considerations emerged.  Patients indicated a positive attitude toward using an MEO as a rehabilitation tool.  They desired a streamlined, stronger device to support them and assist during activities of daily living (ADL).  The authors concluded that for patients with BPI, a well-designed MEO that meets their needs could assist with rehabilitation and increase independence in ADL.  Continued patient engagement in the evaluation and development of both medical devices and treatment plans offers the best opportunity for improved outcomes that are important to the patient.

The authors stated that this study had several drawbacks.  Although the clinic where participants were recruited is a large international center for diagnosis and treatment of BPIs, it may not represent all centers that treat BPIs; and preferences may vary geographically or culturally.  Furthermore, this study’s small sample size (n = 8) could have implications on reaching data saturation.  Although the authors confirmed the perspectives presented in the focus group with individual interviews, additional patients could be contacted for member checking.  Regardless, the themes generated by this study could help providers understand the lived experiences of individuals with BPIs.  Although this study’s cohort reflected the patient population at large (90 % male), including additional females in the study could have further presented unique perspectives that should be considered (e.g., anatomy and ADL).  In addition, while experience with the device was controlled for, daily wear time was not, possibly affecting participant views of the MEO.  Furthermore, the MEO model was not controlled for, and, as such, participants had various versions of the device; therefore, components like batteries and EMG sensors on the device varied depending on which device version was available at the time each participant was prescribed the MEO.  This may have also influenced their experiences and perspectives expressed.

Pulos et al (2021) stated that adult traumatic BPIs could result in severe impairment following penetrating wounds, falls, and motor vehicle accidents (MVAs) or other high-energy trauma.  In a retrospective study, these researchers examined functional outcomes of adult patients with a BPI using a MEO to restore elbow flexion.  A clinic specializing in the BPI treatment at a large academic medical center tested 19 adult patients with BPI.  These patients had failed to achieve anti-gravity elbow flexion following their injury and observation or surgical reconstruction.  They were provided a MEO if they had detectable EMG signals.  There was significant improvement in strength and significant reductions in function and pain when using an MEO.  Following initiation of the MEO, 12 of the 19 patients had clinical improvements in muscle strength, 15 patients showed improvement in their DASH, and 13 patients reported improvements in their VAS.  The authors concluded that the use of an MEO improved elbow flexion strength, increased function, and reduced pain in the majority of patients with BPI and inadequate elbow flexion following observation or surgical reconstruction.

These researchers stated that they recognized the drawbacks inherent in this retrospective study.  Given the heterogeneity of this injury, time from injury to being seen in the clinic, and patient factors, studies in patients with adult traumatic BPI can be difficult to interpret.  For example, free-functioning muscle transfers have out-performed nerve transfers for restoration of elbow flexion strength in patients with complete BPIs and patients with free-functioning muscle transfers were provided an MEO earlier than those with nerve transfers in this trial.  There may be a potential selection bias in who was able to obtain a MEO secondary to socio-economic factors that were not examined in this study; however, the indications for application of the MEO were clearly defined.  Finally, the objective of the study was to determine the applicability of a MEO for elbow flexion in patients with BPI and not to evaluate the cost and availability of the MEO.

Constantino et al (2022) stated that robot-assisted therapy is an innovative approach to upper-limb rehabilitation that uses intensive, repetitive, interactive, and individualized practice as an optimal strategy to enhance motor learning.  An example of upper-limb robot-assisted therapy is the myoelectric orthosis MyoPro.  It is a custom-fabricated myoelectric elbow-wrist-hand orthosis (MEWHO) with built-in surface sensors that detect the user's EMG signals during muscle contraction.  Studies on the MEWHO have focused mostly on elderly chronic stroke patients; none had discussed its use on the adolescent population and the considerations they face in wearing the orthosis.  A 15-year-old male 10th-grade student with a diagnosis of right spastic hemiplegia secondary to CP was prescribed a MEWHO because of muscle weakness of his right upper extremity, decreased functional status, and fine motor skills deficits.  After 2 occupational therapy (OT) cycles, the patient demonstrated improvements in functional strength and performance of physical activities.  Despite these improvements, the patient only used the MEWHO during therapy and was less engaged with its use at home and school.  The authors concluded that this case report presented insights on why the patient was not as proficient and interested in using the orthosis at home and school.  Recommendations to address these issues included peer modeling, community outings, early intervention, and the use of family-centered approaches.  These researchers stated that future studies are also suggested to further understand MEWHO use and the considerations for successful orthotic management in this group of patients.

Pundik et al (2022) noted that technologies that enhance motor learning-based therapy and are clinically deployable may improve outcome for those with neurological deficits.  The MyoPro is a customized myoelectric upper extremity orthosis that employs volitionally generated weak EMG signals from paretic muscles to assist movement of an impaired arm.  In a pilot study, these researchers examined the use of MyoPro as a tool for motor learning-based therapy for individuals with chronic upper limb weakness.  This trial included 13 individuals with chronic moderate/severe arm weakness due to either stroke (n = 7) or TBI (n = 6) who participated in a single group interventional study consisting of 2 phases.  The in-clinic phase included 18 sessions (2 times per week, 27 hours of face-to-face therapy) plus a home exercise program.  The home phase included practice of the home exercise program.  The study did not include a control group.  Outcomes were collected at baseline and at weeks 3, 5, 7, 9, 12, 15, and 18.  Statistics included mixed model regression analysis.  Statistically significant and clinically meaningful improvements were observed on Fugl-Meyer (+ 7.5 points).  Gains were observed at week 3, increased further through the in-clinic phase and were maintained during the home phase.  Statistically significant changes in Modified Ashworth Scale, ROM, and Chedoke Arm and Hand Activity Inventory were observed early during the in-clinic phase.  Orthotic and Prosthetic User's Survey demonstrated satisfaction with the device throughout study participation.  Both stroke and TBI participants responded to the intervention.  The authors concluded that the use of MyoPro in motor learning-based therapy resulted in clinically significant gains with a relatively short duration of in-person treatment.  Moreover, these investigators stated that further studies using a randomized, controlled design are needed.

These researchers stated that while the results are encouraging, this study had several drawbacks.  The sample size was small (n = 13), no blinding was employed, and no comparison group was included.  This curtailed generalization of the results.  However, these investigators observed changes across impairment and function that deserve further study with a more rigorously controlled study design.  In addition, this was a cohort of mixed diagnoses and heterogenous in terms of level of impairment.

Chang et al (2024) noted that most stroke survivors have persistent UL impairments following completing standard clinical care.  The resulting impairments can adversely affect their QOL and ability to complete self-care tasks and remain employed, resulting in increased healthcare and societal costs.  A myoelectric arm orthosis can be used to support the affected weak arm and increase an individual’s use of that arm.  In a retrospective study, these researchers examined the outcomes and clinical benefits provided by the MyoPro orthosis in individuals 65 years of age or older with UL impairment secondary to a stroke.  The DASH questionnaire was administered to individuals who have chronic stroke both before and after receiving their myoelectric orthosis.  A Generalized Estimating Equation model was analyzed.  After using the MyoPro, 19 individuals with chronic stroke had a mean improvement (decrease) in DASH score of 18.07, (95 % CI: -25.41 to -10.72), adjusted for 8 co-variates, with a median time of 11.7 months after receiving the MyoPro.  This large change in DASH score was statistically significant and clinically meaningful as subjects self-reported an improvement with engagement in functional tasks.  The authors concluded that the use of the MyoPro increased independence in functional tasks as reported by the validated DASH outcome measure for older individuals with chronic stroke.  Moreover, these researchers stated that future studies should focus on a larger sample size, a comparison group or groups, examining the relationship of DASH outcome scores and quantitative force measurement changes, ascertaining gains after set time-points, and specifically isolating different parameters that could affect the benefit of the MyoPro such as the way in which the myoelectric orthosis is used in combination with therapy.

The authors stated that this study had several drawbacks.  First, these investigators did not prescribe the frequency or engagement in therapy, medications, home exercise programs, or use of the MyoPro, which could affect subjects’ reports of functional change.  Second, because this was a retrospective study carried out remotely using video-conference technology, these researchers were unable to record strength measurements.  Third, this study had a small sample size (n = 19) and multiple external variables and did not categorize participants by the kind of stroke, location, or severity of deficits presented. Fourth, subjects had varying completion timelines of the post-MyoPro DASH after delivery (6.8 to 17.4 months), which could influence the reported differences in scores.  Fifth, the pre-MyoPro DASH was administered by various clinical staff and the post-MyoPro DASH was administered by multiple study staff, potentially resulting in rater variability or bias.  Moreover, these investigators noted that the use of the DASH questionnaire allowed these researchers to evaluate basic improvement in ADLs; however, the DASH may not be the best measure of true UL improvement and does not specify that the respondent rate the task completion with respect to their affected arm.

Park et al (2024) stated that SCI rehabilitation emphasizes locomotion, and RAGT is often used in clinical settings because of its benefits; however, its effectiveness remains controversial.  In a systematic review and meta-analysis, these investigators examined the effectiveness of RAGT in patients with SCI.  They searched international and domestic databases for studies published until April 18, 2024.  The meta-analysis used a random effects model to examine the effect size as either MD or SMD.  Evidence quality was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.  A total of 23 studies with 690 subjects were included in the final analysis.  The overall pooled effect size for improvement in ADL was 0.24, with SMD (95 % CI: 0.04 to 0.43; GRADE: high) favoring RAGT over conventional rehabilitation.  Muscular strength (MD, 0.23; 95 % CI: 0.02 to 0.44; GRADE: high), walking index for SCI (MD, 0.31; 95 % CI: 0.07 to 0.55; GRADE: moderate) and 6MWT distance (MD, 0.38; 95 % CI: 0.14 to 0.63; GRADE: moderate) showed significant improvement in the robot group.  Subgroup analysis showed that subacute patients and intervention periods of greater than 2 months were more effective.  The authors concluded that this meta-analysis revealed that RAGT significantly improved ADL, muscular strength, and walking abilities.  Moreover, these investigators stated that additional studies are needed to identify the optimal treatment protocol and specific patient groups for which the protocol is most effective.

Jiang et al (2024) noted that RAGT has been reported to treat motor dysfunction in patients with Parkinson's disease (PD) in the last few years; however, the benefits of RAGT in the treatment of motor dysfunction in PD patients are still unclear.  In a systematic review and meta-analysis, these investigators examined the effectiveness of RAGT for motor dysfunction in PD patients.  They searched PubMed, Web of Science, Cochrane Library, Embase, CNKI, Wanfang, Chinese Biomedical Literature Database (CBM), and Chinese VIP Database for RCTs examining RAGT to improve motor dysfunction in PD from the databases' inception dates until September 1, 2022.  The following outcome indexes were used to evaluate motor dysfunction: the Berg Balance Scale (BBS), Activities-specific Balance Confidence Scale (ABC), 10-Meter Walk Test gait speed (10-MWT), gait speed, stride length, cadence Unified Parkinson Disease Rating Scale Part III (UPDRS III), 6MWT, and the Timed Up and Go test (TUG).  The meta-analysis was performed using the proper random effect model or fixed-effect model to examine the difference in effectiveness between the RAGT and the control groups.  The Cochrane Risk of Bias Tool was used for the included studies and the GRADE approach was used to interpret the certainty of the results.  The results consisted of 17 studies comprising 670 participants.  A total of 607 PD patients with motor dysfunction were included: 335 in the RAGT group, and 335 in the control group.  This meta-analysis results established that when compared with the control group, RAGT improved the BBS results of PD patients (MD: 2.80, 95 % CI: 2.11 to 3.49, p < 0.00001), ABC score (MD: 7.30, 95 % CI: 5.08 to 9.52, p < 0.00001), 10-MWT (MD: 0.06, 95 % CI: 0.03 to 0.10, p =  0.0009), gait speed (MD: 3.67, 95 % CI: 2.58 to 4.76, p < 0.00001), stride length (MD: 5.53, 95 % CI: 3.64 to 7.42, p < 0.00001), cadence (MD: 4.52, 95 %CI: 0.94 to 8.10, p = 0.01), UPDRS III (MD: -2.16, 95 % CI: -2.48 to -1.83, p < 0.00001), 6MWT (MD: 13.87, 95 % CI: 11.92 to 15.82, p < 0.00001).  However, RAGT did not significantly improve the TUG test result of patients with PD (MD = -0.56, 95 % CI: -1.12 to 0.00, p = 0.05).  No safety concerns or adverse reactions among RAGT patients were observed.  The authors concluded that even though RAGT could improve balance function, walking function, and gait performance and has shown positive results in several studies, there is currently insufficient compelling evidence to suggest that it can improve all aspects of lower motor function.

IpsiHand

Holmes (2012) stated that stroke and other nervous system injuries can damage or destroy hand motor control and significantly upset ADL.  Brain computer interfaces (BCIs) represent an emerging technology that could bypass damaged nerves to restore basic motor function and provide more effective rehabilitation.  A wireless BCI system was implemented to realize these objectives using EEG brain signals, machine learning (ML) techniques, and a custom-designed orthosis.  The IpsiHand Bravo BCI system was designed to reach a large demographic by using non-traditional brain signals and improving on past BCI system pitfalls.  These investigators noted that at the time of this manuscript’s submission, a case study entailing an individual stroke patient using the IpsiHand system had commenced.  While the patient appeared to attain reasonable control using the IpsiHand Bravo BCI system, the results of this long-term study will give insight into the rehabilitation potential  associated with extended use of the IpsiHand system.  Moreover, these researchers stated that future development of IpsiHand will be aimed at moving  the signal processing and Eos ML Software to an on-board micro-computer, to increase portability as well as ease-of-use.  Improving system accuracy and training speed will also maximize the time available for patient therapy.

Remsik et al (2016) noted that stroke is a leading cause of acquired disability resulting in distal UE functional motor impairment.  Stroke mortality rates continue to decline with advances in healthcare and medical technology.  This has resulted in an increased demand for advanced, personalized rehabilitation.  Survivors often experience some level of spontaneous recovery shortly after their stroke event, yet reach a functional plateau after which there is exiguous motor recovery.  Nevertheless, studies have shown the potential for recovery beyond this plateau.  Non-traditional neuro-rehabilitation techniques, such as those incorporating the BCI, are being examined for stroke rehabilitation.  BCIs may offer a gateway to the brain's plasticity and revolutionize how humans interact with the world.  Non-invasive BCIs work by closing the proprioceptive feedback loop with real-time, multi-sensory feedback allowing for volitional modulation of brain signals to help hand function.  The authors noted that several BCI studies were carried out on healthy subjects, which posited the needs for more methodological studies performed on individuals post-stroke for future clinical studies.  These researchers concluded that BCI holds great promise as a future cost-effective, in-home, adaptive, augmentative medical device platform for stroke survivors.

Nojima et al (2022) stated that BCI is a procedure involving brain activity in which neural status is provided to the participants for self-regulation.  Ina meta-analysis, these investigators examined the effect sizes of clinical studies investigating the use of BCI-based rehabilitation interventions in restoring UE function and effective methods to detect brain activity for motor recovery.  They carried out a computerized search of Medline, CENTRAL, Web of Science, and PEDro to identify relevant studies.  These researchers elected clinical trials that used BCI-based training for post-stroke patients and provided motor assessment scores before and after the intervention.  The pooled SMDs of BCI-based training were calculated using the random-effects model.  They initially identified 655 potentially relevant studies; 16 met the inclusion criteria, entailing 382 subjects.  A significant effect of neurofeedback intervention for the paretic UL was observed (SMD = 0.48, [0.16 to 0.80], p = 0.006).  However, the effect estimates were moderately heterogeneous among the studies (I2 = 45 %, p = 0.03).  Subgroup analysis of the method of measurement of brain activity indicated the effectiveness of the algorithm focusing on sensorimotor rhythm.  The authors concluded that the findings of this meta-analysis suggested that BCI-based training was superior to conventional interventions for motor recovery of the UL in patients with stroke; however, the results were not conclusive because of a high-risk of bias and a large degree of heterogeneity due to the differences in the BCI interventions and the participants; thus, further studies involving larger cohorts are needed to confirm these findings.

Rustamov et al (2023) noted that chronic hemiparetic stroke patients have very limited benefits from current therapies; BCI engaging the unaffected hemisphere has emerged as a promising novel therapeutic approach for chronic stroke rehabilitation. These investigators examined the effectiveness of the IpsiHand System in the management of chronic stroke patients with impaired UE motor function.  They further examined neurophysiological features of motor recovery affected by BCI.  These researchers hypothesized that BCI therapy would induce a broad motor recovery in the UE (proximal and distal), and there would be corresponding changes in baseline theta and gamma oscillations, which have been shown to be associated with motor recovery.  A total of 30 chronic hemiparetic stroke patients carried out a therapeutic BCI task for 12 weeks.  Motor function assessment data and resting state EEG signals were acquired before initiating BCI therapy and across BCI therapy sessions.  The UE Fugl-Meyer assessment (UEFM) served as a primary motor outcome assessment tool; and theta-gamma cross-frequency coupling (CFC) was computed and correlated with motor recovery.  Chronic stroke patients attained significant motor improvement with BCI therapy.  They found significant improvement in both proximal and distal UE motor function.  More importantly, motor function improvement was independent of Botox application.  Theta-gamma CFC enhanced bilaterally over the C3 and C4 motor electrodes following BCI therapy.  These investigators observed significant positive correlations between motor recovery and theta gamma CFC increase across BCI therapy sessions.  The authors concluded that BCI therapy resulted in significant motor function improvement across the proximal and distal UE of chronic stroke patients.  This therapy was significantly correlated with changes in baseline cortical dynamics, specifically theta-gamma CFC increases in both the right and left motor regions.  This may represent rhythm-specific cortical oscillatory mechanism for BCI-driven motor rehabilitation in chronic stroke patients.  Moreover, these researchers stated that these findings warrant large-scale RCTs to further establish the effectiveness of BCI-driven motor rehabilitation in chronic stroke.

The authors stated that this trial had 2 main drawbacks.  First, this study was carried out with the assumption that motor deficits would remain stable in the chronic stage of stroke; therefore, they did not have a BCI control group.  Second, these investigators could not determine whether enhanced theta-gamma coupling is specific to BCI techniques or if it represents a broader phenomenon associated with other methods utilized for chronic stroke rehabilitation.

Qu et al (2024) stated that many recent studies have suggested that the combination of BCIs can induce neurological recovery and improvement in motor function.  In a systematic review and meta-analysis, these investigators examined the effectiveness of BCI-robot systems.  They searched for pertinent studies published from January 2010 to December 2020 by using the databases (Embase, PubMed, CINAHL, EBSCO, Web of Science and manual search).  The single-group studies were qualitatively described, and only the controlled-trial studies were included for the meta-analysis.  The MD of Fugl-Meyer Assessment (FMA) scores were pooled and the random-effects model method was used to perform the meta-analysis; and the PRISMA guidelines were followed in current review.  A total of 897 studies were identified, 8 single-group studies, and 11 controlled-trial studies were included in this review.  The systematic analysis indicated that the BCI-robot systems had a significant improvement on motor function recovery.  The meta-analysis showed there were no statistic differences between BCI-robot groups and robot groups, neither in the immediate effects nor long-term effects (p > 0.05).  The authors concluded that the use of BCI-robot systems has significant improvement on the motor function recovery of hemiparetic UL, and there is a sustaining effect.  The meta-analysis showed no statistical difference between the experimental group (BCI-robot) and the control group (robot); however, there are a few shortcomings in the experimental design of existing studies, more clinical trials with larger sample size, novel external devices, and BCI systems need to be carried out, and the experimental design needs to be more rigorous, and describe the experimental designs in detail, especially the control group intervention, to make the experiment replicable.  These investigators also stated that further research could shift the focus to the patients who are in subacute stage, to examine if the early BCI training can make a positive impact on cerebral cortical recovery; and new evaluation criteria need to be established, more objective assessment such as biomechanical assessment, fMRI should be employed as the primary outcome.

Brunner et al (2024) noted that restorative BCI that combine motor imagery with visual feedback and functional electrical stimulation (FES) may offer much-needed treatment alternatives for patients with severely impaired UL function after a stroke.  In a randomized-controlled, pilot study, these researchers examined if BCI-based training, combining motor imagery with FES targeting finger/wrist extensors, is more effective in improving severely impaired UL motor function than conventional therapy in the subacute phase after stroke, and if patients with preserved cortical-spinal tract (CST) integrity would benefit more from BCI training.  A total of 40 patients with severe UL paresis (less than 13 on ARAT score) were randomized to either a 12-session BCI training as part of their rehabilitation or conventional UL rehabilitation.  BCI sessions were conducted 3 to 4 times weekly for 3 to 4 weeks.  At baseline, transcranial magnetic stimulation (TMS) was carried out to examine CST integrity.  The main endpoint was the ARAT score at 3 months post-stroke.  A bi-nominal logistic regression was performed to examine the effect of treatment group and CST integrity on achieving meaningful improvement.  In the BCI group, EEG data were analyzed to examine changes in event-related desynchronization (ERD) during the course of therapy.  Data from 35 patients (15 in the BCI group and 20 in the control group) were analyzed at 3-month follow-up.  Few patients (10/35) improved above the minimally clinically important difference (MCID) of 6 points on ARAT score, 5/15 in the BCI group, 5/20 in control.  An independent-samples Mann-Whitney U test showed no differences between the 2 groups (p = 0.382).  In the logistic regression only CST integrity was a significant predictor for improving UL motor function (p = 0.007).  The EEG analysis showed significant changes in ERD of the affected hemisphere and its lateralization only during unaffected UL motor imagery at the end of the therapy.  The authors concluded that this was the 1st RCT examining BCI training in the subacute phase where only patients with severe UL paresis were included.  Although more patients in the BCI group improved relative to the group size, the difference between the groups was not significant.  In this pilot study, preserved CTS integrity was much more vital for UL improvement than which type of intervention the patients received.  These researchers stated that larger studies including only patients with some preserved CST integrity should be attempted.

Motus Hand and Foot Devices

The Motus Hand is the only FDA Class 1 at-home stroke rehabilitation robot in the world with active assistance.  The Motus Hand supposedly induces equivalent functional improvements to those observed with standard clinical care.  The Motus technology employs high-dose repetitive task practice to induce neuroplasticity to help stroke survivors improve walking speed as well as endurance.  Moreover, the Motus Hand can aid in improving range of motion (ROM) and strength of patient’s arm and increase functional capacity.

Kutner et al (2010) stated that at 6 months post-stroke, most patients could not incorporate their affected hand into daily activities, which in turn is likely to reduce their perceived QOL.  In a single-blind, multi-center, randomized clinical study, these researchers examined change in patient-reported, health-related QOL (HR-QOL) associated with robotic-assisted therapy combined with reduced therapist-supervised training.  A total of 17 individuals who were 3 to 9 months post-stroke were enrolled in this trial; 60 hours of therapist-supervised repetitive task practice (RTP) was compared with 30 hours of RTP combined with 30 hours of robotic-assisted therapy.  Participants completed the SIS at baseline, immediately post-intervention, and 2 months post-intervention.  Change in SIS score domains was evaluated in a mixed model analysis.  The combined therapy group had a greater increase in rating of mood from pre-intervention to post-intervention, and the RTP-only group had a greater increase in rating of social participation from pre-intervention to follow-up.  Both groups had statistically significant improvement in ADL and instrumental ADL scores from pre-intervention to post-intervention.  Both groups reported significant improvement in hand function post-intervention and at follow-up, and the magnitude of these changes suggested clinical significance.  The combined therapy group had significant improvements in stroke recovery rating post-intervention and at follow-up, which appeared clinically significant; this also was true for stroke recovery rating from pre-intervention to follow-up in the RTP-only group.  The authors concluded that robotic-assisted therapy may be an effective alternative or adjunct to the delivery of intensive task practice interventions to enhance hand function recovery in patients with stroke.

The authors stated that a drawback of this trial was the lack of understanding regarding the necessary dose of RTP to elicit the current level of improvements in motor function.  Limiting training to 30 hours of RTP might be sufficient for patients to reach a plateau in terms of improved motor function.  In this case, the robotic device may not be contributing to change in the perception of hand function.  These researchers noted that they were engaged in studies examining the dose response of RTP and RTP+Hand Mentor (HM) to dissociate the contributions of task practice and robotic therapy to enhanced perception of hand function.  Although a potential benefit of employing a robotic device is the reduction of the amount of therapist-directed RTP; thus, potentially providing a cost-savings to the delivery of RTP interventions, the results from the current study did not directly examine the potential cost-savings.  In this trial, the HM was used in a clinical environment and under the supervision of a therapist.  It was unclear whether the same level of intensity and adherence would occur if a patient used the device in a home environment.  These investigators stated that future studies in which the HM is used in a home environment to complete outpatient RTP will be carried out.  These trials will provide important data regarding any cost-savings associated with the HM, feasibility of home use, and patient adherence to intended use of the system.  It also will be important to continue to examine the potential effect of decreased therapist time on patients’ rating of the social participation dimension of their perceived QOL.  At the same time, these results were the first to show that HR-QOL measures specific to distal hand function could be improved following a combined robotic and RTP therapeutic approach.

Linder et al (2013) noted that because many post-stroke persons lack access to the quality and intensity of rehabilitation to improve UE motor function, a home-based robotic-assisted UE rehabilitation device is being paired with an individualized home exercise program (HEP).  In a RCT, these researchers examined the effectiveness of robotic-assisted home therapy compared to a home exercise program on UE motor recovery and HR-QOL for stroke survivors in rural and under-served locations.  The secondary objective was to examine if initial degree of motor function of the UL may be a factor in predicting the extent to which patients with stroke may be responsive to a home therapy approach.  These investigators hypothesized that the HEP intervention, when enhanced with robotic-assisted therapy, would result in significantly better outcomes in motor function and QOL.  A total of 96 participants within 6 months of a single, unilateral ischemic or hemorrhagic stroke will be recruited in this prospective, single-blind, multi-center, randomized clinical trial.  The primary outcome is the change in UE function using the Action Research Arm Test (ARAT) score.  Secondary outcomes include changes in: UE function (Wolf Motor Function Test), UE impairment (UE portion of the Fugl-Meyer Test), self-reported QOL (SIS), and affect (Centers for Epidemiologic Studies Depression Scale).  The authors stated that results from this trial will provide insights into the feasibility and effectiveness of using a robotic device to augment a HEP designed to improve UE function post-stroke.  Behavioral components surrounding compliance with a self-administered rehabilitation program that includes robotic-assisted therapy will be determined.  Furthermore, this study will examine if this approach may exhibit different effects as a function of the participant’s initial level of UE motor function.  The identification of individuals who are responsive to this intervention approach may increase access to rehabilitative care for a population traditionally excluded from large-scale stroke trials.

Wolf et al (2015) stated that geographical location, socio-economic status as well as logistics surrounding transportation impede access of post-stroke individuals to comprehensive rehabilitative services.  Robotic therapy may enhance tele-rehabilitation by delivering consistent and state-of-the art therapy while allowing for the remote monitoring, and adjusting therapy for under-served populations.  The Hand Mentor Pro (HMP) was incorporated within a HEP to improve UE functional capabilities post-stroke.  In a prospective, single-blinded, multi-center RCT, these researchers examined the effectiveness of a home-based tele-monitored robotic-assisted therapy as part of a HEP compared with a dose-matched HEP-only intervention among individuals less than 6 months post-stroke and characterized as under-served.  This study included 99 hemiparetic subjects with limited access to UE rehabilitation; they were randomized to 1 of the 2 groups: experimental group which received combined HEP and HMP for 3 hours/day x 5 days x 8 weeks; or control group which received HEP only at an identical dosage.  Weekly communication between the supervising therapist and participant promoted compliance and progression of the HEP and HMP prescription.  The ARAT score and Wolf Motor Function Test along with the Fugl Meyer Assessment (UE) were primary and secondary outcome measures, respectively, undertaken before and after the interventions.  Both groups reported improvement across all UE outcomes.  The authors concluded that robotic+HEP and HEP only were both effectively delivered remotely.  There was no difference between groups in change in motor function over time.  These investigators stated that further investigations with more detailed selection of users are needed to determine appropriate dosage of HMP and HEP.

Housley et al (2016) noted that an estimated 750,000 Americans experience a stroke every year; and most stroke survivors require rehabilitation.  Limited access to rehabilitation facilities has a pronounced burden on functional outcomes and QOL.  Robotic devices deliver reproducible therapy without the need for real-time human oversight.  These researchers examined the effectiveness of using home-based, telerobotic-assisted devices (Hand and Foot Mentor: HM and FM) to improve functional ability and reduce depression symptoms, while improving access and cost savings associated with rehabilitation.  A total of 20 stroke survivors carried out 3 months of home-based rehabilitation using a robotic device, while a therapist remotely monitored progress.  Baseline and end of treatment function and depression symptoms were assessed.  Satisfaction with the device and access to therapy were determined using qualitative surveys.  Cost-analysis was conducted to compare home-based, robotic-assisted therapy to clinic-based PT.  Compared to baseline, significant improvement in UE function (30.06 %, p = 0.046), clinically significant benefits in gait speed (29.03 %), moderate improvement in depressive symptoms (28.44 %) and modest improvement in distance walked (30.2 %) were observed; and subjects indicated satisfaction with the device. Home-based robotic therapy expanded access to post-stroke rehabilitation for 35 % of individuals no longer receiving formal services and increased daily access for the remaining 65 %, with a cost-savings of $2,352 (64.97 %) compared to clinic-based PT.  The authors concluded that stroke survivors made significant clinically meaningful improvements in the use of their impaired extremities using a robotic device in the home.  These researchers stated that home-based, robotic therapy reduced costs, while expanding access to a rehabilitation modality for individuals who would not otherwise have received care.  Moreover, they stated that future studies with the HM and FM should employ larger sample sizes, and involve non-Veteran subjects with heterogeneous levels of impairment, which may help elucidate these initial observations.  Furthermore, the authors stated that further investigations should address heterogeneous training volume by holding the training dose constant across the entire intervention.  Monitoring cumulative training time and allowing the number of sessions to increase or decrease to accommodate the literature supported recommended dosing for UE rehabilitation, will ensure a dose match across subjects and experimental groups.

These investigators stated that this study had several drawbacks.  First, although the target treatment time was initially set at 2 hours of daily therapy over the course the 3-month trial, and weekly therapist involvement attempted to alleviate this challenge, large heterogeneity in participation still persisted.  Second, recruitment was focused on the Veteran populations in the Southeast U.S. resulting in subjects consisting of a much greater number of men than women; thus, the external validity of these findings was limited.  Third, a single-group study design was employed, instead of 2-group RCT.  Studies without a placebo or randomized comparison group may leave these findings open to many possible interpretations and explanations.  Fourth, while the results potentially represent a 64.97 % and 36.3 % reduction of out-patient therapy costs (for VA healthcare and civilian , respectively) across both arm and foot devices for stroke survivors these were estimated costs.  This study was not designed to directly compare costs and had no control group.  In addition, although the results of this study highlighted the potential for home-based, robotic-assisted tele-rehabilitation to increase access to rehabilitation for stroke survivors, these researchers acknowledged that this intervention is intended to augment human therapist services not replace them.

In a pilot study, O'Brien Cherry (2017) reported on a robotic stroke therapy delivery and monitoring system intervention.  The objectives of this pilot implementation project were to determine subjects' general impressions regarding the benefits and barriers of using robotic therapy devices for in-home rehabilitation.  These researchers employed a qualitative study design using ethnographic-based anthropological methods including direct observation of the in-home environment and in-depth semi-structured interviews with 10 users of the hand or foot robotic devices.  Thematic analysis was carried out using an inductive approach.  Subjects reported positive experiences with the robotic stroke therapy delivery and monitoring system.  Benefits included convenience, self-reported increased mobility, improved mood, and an outlet for physical as well as mental tension and anxiety.  Barriers to use were few and included difficulties with placing the device on the body, bulkiness of the monitor and modem connection problems.  The authors concluded that tele-rehabilitation robotic devices could be used as a tool to extend effective, evidence-based and specialized rehabilitation services for UE and LE rehabilitation to rural Veterans with poor access to care.  Participants whose formal therapy services had ended either because they had exhausted their benefits or because traveling to out-patient therapy was too cumbersome due to distance were able to perform therapeutic activities in the home daily (or at least multiple times per week).  Subjects who were still receiving formal therapy services either in-home or in the clinic were able to perform therapeutic activities in the home on the days they were not attending/receiving formal therapy.  Based on the feedback from these veterans and their care-givers, the manufacturing company is working on modifying the devices to be less cumbersome and more user-friendly (lighter-weight, more mobile, changing software, etc.), as well as more adaptable to participants' homes.  Removing these specific barriers will potentially allow participants to use the device more easily and more frequently.  Since participants expressed that they wished they could have the device in their homes longer than the 3-month usage period needed for this pilot project, the project team worked on a proposal to extend this project to a wider area and the new paradigm would extend the usage period until the patient reaches a plateau in progress or no longer wants to use the device.

Suarez-Escobar and Rendon-Velez (2018) examined the current state-of-the-art of robotic/mechanical devices for post-stroke thumb rehabilitation as well as the anatomical characteristics and motions of the thumb that are crucial for the development of any device that aims to support its motion.  These investigators carried out a systematic literature search to identify robotic/mechanical devices for post-stroke thumb rehabilitation.  Specific electronic databases and well-defined search terms and inclusion/exclusion criteria were used for such purpose.  A reasoning model was devised to support the structured abstraction of relevant data from the literature of interest.  Following the main search and after removing duplicated and other non-relevant studies, a total of 68 studies (corresponding to 32 devices) were left for further examination.  These studies were analyzed to extract data relative to the motions assisted/permitted -- either actively or passively -- by the device per anatomical joint of the thumb; and mechanical-related aspects (i.e., architecture, connections to thumb, other fingers supported, adjustability to different hand sizes, actuators -- type, quantity, location, power transmission and motion trajectory).  The authors concluded that most studies described preliminary design and testing of prototypes, rather than the thorough evaluation of commercially ready devices.  Defining appropriate kinematic models of the thumb upon which to design such devices still remains a challenging and unresolved task.  These investigators stated that further research is needed before these devices could actually be implemented in clinical environments to serve their intended purpose of complementing the labor of therapists by facilitating intensive treatment with precise and repeatable exercises.  Post-stroke functional disability of the hand, and especially of the thumb, significantly affects the capability to perform ADL, threatening the independence and QOL of stroke survivors.  The latest studies showed that a high-dose intensive therapy (in terms of frequency, duration and intensity/effort) is the key to effectively modify neural organization and recover the motor skills that were lost following a stroke.  Conventional therapy based on manual interaction with physical therapists makes the procedure labor-intensive and increases the costs.  Robotic/mechanical devices hold promise for complementing conventional post-stroke therapy.  Specifically, these devices could provide reliable and accurate therapy for long periods of time without the associated fatigue.  In addition, they could be used as a means to evaluate patients’ performance and progress in an objective and consistent manner.  These researchers stated that the  full potential of robot-assisted therapy is still to be unveiled.  Further investigations will surely lead to devices that could be well-accepted equally by therapists and patients and that could be useful both in clinical and home-based rehabilitation practice such that motor recovery of the hand becomes a common outcome in stroke survivors.  The authors stated that this overview provided the reader, possibly a designer of such a device, with a complete overview of the state-of-the-art of robotic/mechanical devices consisting of or including features for the rehabilitation of the thumb.  Furthermore, these investigators clarified the anatomical characteristics and motions of the thumb that are crucial for the development of any device that aims to support its motion.  They hoped that this combined with the outlined opportunities for further research would lead to the improvement of current devices and the development of new technology and knowledge in the field.

Park et al (2020) examined the performance of a robotic orthosis designed to help the paretic hand following stroke.  It is wearable and fully user-controlled, serving 2 possible roles: as a therapeutic tool that facilitates device-mediated hand exercises to recover neuromuscular function or as an assistive device for use in everyday activities to aid functional use of the hand.  In a pilot study, these researchers presented the clinical outcomes of a wearable hand robot used by individuals after stroke.  A total of 11 chronic stroke (greater than 2 years) patients with moderate muscle tone (MAS of 2 or less in UE) engaged in a month-long training protocol using the orthosis.  Participants were evaluated using standardized outcome measures, both with and without orthosis assistance.  Fugl-Meyer post-intervention scores without robotic assistance showed improvement focused specifically on the distal joints of the upper limb, suggesting the use of the orthosis as a rehabilitative device for the hand.  ARAT scores post-intervention with robotic assistance showed that the device may serve an assistive role in grasping tasks.  The authors concluded that these findings highlighted the potential for wearable and user-driven robotic hand orthoses to extend the use and training of the affected upper limb following stroke.   These researchers stated that such devices may enable robotic based-hand rehabilitation during daily activities (as opposed to isolated hand exercises with limited UE engagement) and over extended periods of time, even in a patient’s home environment.  They noted that many challenges must still be overcome in order to achieve this vision, related to design (compact devices with easier donning/doffing), control (robust yet intuitive intent inferral), and effectiveness (improved functionality in a wider range of metrics).  However, if these challenges can be addressed, wearable robotic devices have the potential to greatly extend the use and training of the affected UE after stroke, and help improve the QOL for a large patient population.

Rogers et al (2020) stated that loss of arm function is common following stroke; and robot-assisted training may improve arm outcomes.  In an observer-blind, multi-center RCT with embedded health economic and process evaluations, these researchers examined the clinical effectiveness and cost-effectiveness of robot-assisted training, compared with an enhanced UL therapy program and with usual care.  Patients with moderate or severe UL functional limitation, between 1 week and 5 years following 1st stroke, were recruited.  Interventions entailed robot-assisted training using the Massachusetts Institute of Technology (MIT)-Manus robotic gym system (InMotion commercial version, Interactive Motion Technologies, Inc., Watertown, MA), an enhanced UL therapy program comprising repetitive functional task practice, and usual care.  The primary outcome was UL functional recovery “success” (assessed using the ARAT score) at 3 months.  Secondary outcomes at 3 and 6 months were the ARAT results, UL impairment (measured using the Fugl-Meyer Assessment), ADL (measured using the BI), QOL (measured using the SIS), resource use costs, and QALYs.  A total of 770 participants were randomised (robot-assisted training, n = 257; enhanced UL therapy, n = 259; usual care, n = 254).  Upper limb functional recovery “success” was achieved in the robot-assisted training [103/232 (44 %)], enhanced UL therapy [118/234 (50 %)] and usual care groups [85/203 (42 %)].  These differences were not statistically significant; the adjusted odds ratios (ORs) were as follows: robot-assisted training versus usual care, 1.2 (98.33 % CI: 0.7 to 2.0); enhanced UL therapy versus usual care, 1.5 (98.33 % CI: 0.9 to 2.5); and robot-assisted training versus enhanced UL therapy, 0.8 (98.33 % CI: 0.5 to 1.3).  The robot-assisted training group had less UL impairment (as measured by the Fugl-Meyer Assessment motor subscale) than the usual care group at 3 and 6 months.  The enhanced UL therapy group had less UL impairment (as measured by the Fugl-Meyer Assessment motor subscale), better mobility (as measured by the SIS mobility domain) and better performance in ADL (as measured by the SIS activities of daily living domain) than the usual care group, at 3 months.  The robot-assisted training group performed less well in ADL (as measured by the SIS activities of daily living domain) than the enhanced UL therapy group at 3 months.  No other differences were clinically important and statistically significant.  Participants found the robot-assisted training and the enhanced UL therapy group programs acceptable.  Neither intervention, as provided in this trial, was cost-effective at current National Institute for Health and Care Excellence (NICE) willingness-to-pay thresholds for a QALYs.  The authors concluded that robot-assisted training did not improve UL function compared with usual care.  Although robot-assisted training improved UL impairment, this did not translate into improvements in other outcomes.  Enhanced UL therapy resulted in potentially important improvements on UL impairment, in performance of ADL, and in mobility.  Neither intervention was cost-effective.  These researchers stated that further investigations are needed to find ways to translate the improvements in UL impairment observed with robot-assisted training into improvements in UL function and ADL.  They stated that innovations to make rehabilitation programs more cost-effective are needed.

Dong et al (2021) stated that the ankle joint complex (AJC) is of fundamental importance for balance, support, and propulsion; however, it is susceptible to musculo-skeletal and neurological injuries, especially neurological injuries such as drop-foot following stroke.  An important factor in ankle dysfunction is damage to the central nervous system (CNS); thus, the key objective of rehabilitation is to stimulate the re-organization and compensation of the CNS, and to promote the recovery of the motor system's motor perception function.  Hence, an increasing number of ankle rehabilitation robots have been developed to provide long-term accurate and uniform rehabilitation of the AJC, among which the parallel ankle rehabilitation robot (PARR) is the most studied.  In a systematic review, these investigators described the state of the art in PARR technology, with consideration of the mechanism configurations, actuator types with different trajectory tracking control techniques, as well as rehabilitation training methods; thereby, facilitating the development of new and improved PARRs as a next step towards obtaining clinical proof of their rehabilitation benefits.  They carried out a literature search on PubMed, Scopus, IEEE Xplore, and Web of Science for studies related to the design and improvement of PARRs for ankle rehabilitation from each site's respective inception from January 1999 to September 2020 using the keywords "parallel", "ankle", and "robot".  Appropriate syntax using Boolean operators and wildcard symbols was employed for each database to include a wider range of studies that may have used alternate spellings or synonyms, and the references listed in relevant publications were further screened according to the inclusion criteria and exclusion criteria.  A total of 65 studies representing 16 unique PARRs were selected for review, all of which have developed the prototypes with experiments designed to verify their usability and feasibility.  From the comparison among these PARRs, these researchers found that there are 3 main considerations for the mechanical design and mechanism optimization of PARRs, the choice of 2 actuator types including pneumatic and electrically driven control, the covering of the AJC's motion space, and the optimization of the kinematic design, actuation design and structural design.  The trajectory tracking accuracy and interactive control performance also need to be guaranteed to improve the effect of rehabilitation training and stimulate a patient's active participation.  Furthermore, the parameters of the reviewed 16 PARRs were summarized in detail with their differences compared by using figures and tables in the order they appeared, showing their differences in the 2 main actuator types, 4 exercise modes, 15 control strategies, etc., which revealed the future research trends related to the improvement of the PARRs.  The authors concluded that the selected studies showed the rapid development of PARRs in terms of their mechanical designs, control strategies, and rehabilitation training methods over the past 20 years; however, the existing PARRs all have their own pros and cons, and few of the developed devices have been subjected to clinical trials.  Designing a PARR with 3 degrees of freedom (DOFs) and whereby the mechanism's rotation center coincides with the AJC rotation center is of vital importance in the mechanism design and optimization of PARRs.  Additionally, the design of actuators combining the advantages of the pneumatic-driven and electrically driven ones, as well as some new other actuators, will be a research hot-spot for the development of PARRs.  For the control strategy, compliance control with variable parameters should be further examined, with sEMG signal included to improve the real-time performance.  Multi-modal rehabilitation training methods with multi-modal motion intention recognition, real-time online detection and evaluation system should also be further developed to meet the needs of different ankle disability and rehabilitation stages.  Furthermore, there is an urgent need for clinical trials to help the PARRs be implementable as an intervention in clinical practice.

He et al (2023) noted that robotic training with high repetitions facilitates UE movements but provides fewer benefits for ADL.  Integrating ADL training tasks and mirror therapy into a robot may enhance the functional gains of robotic training.  In a single-blinded, active-controlled, pilot study, these investigators examined the feasibility, safety, and effectiveness of the task-oriented mirrored UL robotic training on the UL functions and ADL of subacute post-stroke patients.  A total of 32 subacute post-stroke patients were enrolled in the study.  The enrolled patients were allocated into 2 groups in a ratio of 1:1.  The experimental group received 4 weeks of task-oriented mirrored UL robotic training, consisting of 5 sessions of 30-min duration, along with 30 mins of conventional training.  The control group only received 60 mins of conventional training.  The outcome measures were the Fugl-Meyer Assessment Scale for UE, modified BI, Stroke Self-Efficacy Scale, System Usability Scale, and Quebec User Evaluation with Assistive Technology.  All patients completed the full training sessions without significant AEs related to robotic training.  The task-oriented mirrored UL robotic training resulted in increased Fugl-Meyer Assessment Scale for UE (difference: 10.38 points, p < 0.001) and Modified Barthel Index (difference: 18.38 points, p < 0.001) scores, both of which exceeded the minimal clinically important difference (MCID).  Inter-group analysis showed significantly higher improvements in the Fugl-Meyer Assessment Scale for UE total scores, shoulder, wrist, and hand scores; and modified BI scores in the experimental group than in conventional training (all p < 0.05).  Both groups showed significant improvements in Stroke Self-Efficacy Scale scores after the intervention (both p < 0.001), but without a statistically significant inter-group difference (p > 0.05).  Subjects in the experimental group scored an average usability perception score of 74.74 (good) and an average satisfaction score of 4 or more out of 5.  The authors concluded that task-oriented mirrored UL robotic training appeared feasible and safe for subacute post-stroke rehabilitation, facilitating the recovery of UL functions and ADL.  They stated that task-oriented mirrored UL robotic training showed promise for future clinical rehabilitation and clinical trials involving subacute post-stroke patients.  Moreover, these researchers stated that further RCTs with larger sample sizes are needed to confirm the findings of this pilot study.

The authors stated that this trial had several drawbacks.  First, the small sample size (n = 32) and loss of follow-up assessments due to resource and time limitations may limit the generalizations of these findings; thus, caution must be exercised when concluding.  Second, the handedness of hemiparesis patients was not taken into consideration, which could potentially influence the effectiveness of robotic training.  Third, due to the requirements of feedback to training tasks on the screen, patients with unilateral neglect were excluded in this study; however, the unilateral neglect is a common concern in post-stroke research and should be addressed in future studies.  Fourth, whether the combination of task-oriented training, mirror training, and assistive technology offers more benefits than individual training alone remains unclear.  These investigators noted that conducting such comparisons would provide further evidence for the clinical application of these interventions.

Kinova JACO Assistive Robot

Beaudoin et al (2018) noted that robotic arms may aid users in performing various activities.  Even though robotic arms are commercially available, their impacts are still poorly understood.  In a scoping review, these investigators examined the potential impacts of using robotic arms for individuals with UE disabilities and evaluated the scientific quality of the selected studies.  They search for studies published between 1970 and 2016 using PubMed, Embase, Compendex, and Scopus.  The Canadian Model of Occupational Performance and Engagement was employed to classify activities in which impacts were evaluated.  The quality of each study was rated using McMaster University's critical review form for quantitative studies.  A total of 36 studies were reviewed, which examined self-care (21 studies), productivity (33 studies), and leisure (8 studies).  The short-term impacts were more commonly documented than long-term impacts.  The impacts identified were mostly positive; and the studies' mean quality score was 8.8/15.  The authors concluded that additional studies with more rigorous conditions are needed to produce higher-quality scientific evidence of the long-term impacts of robotic arm use.

Beaudoin et al (2019) stated that past research with Jaco robotic arm has primarily focused on the short-term impacts on new users; thus, this trial aimed to document the long-term impacts of this assistive device on users and their family care-givers following prolonged use.  Users' characteristics, care-givers' characteristics as well as expenses related to the Jaco robotic arm were documented with questionnaires designed for this study.  UE performance was measured with an adaptation of an UE performance test, the TEMPA, and accomplishment of life habits was documented in an interview based on the LIFE-H questionnaire.  Satisfaction with Jaco and psychosocial impacts of its use were measured with validated questionnaires, namely the QUEST and the PIADS-10.  Impacts of Jaco on family care-givers were documented with a validated questionnaire, the CATOM.  Descriptive statistics were used to report the results.  A total of 7 users and 5 care-givers were recruited; 1 user had expenses related to Jaco in the past 2 months.  Users had a better UE performance with Jaco than without it and they used their robotic arm to accomplish certain life habits.  Most users were satisfied with Jaco and the psychosocial impacts were positive.  Impacts on family care-givers were slight.  The authors concluded that Jaco enhanced performance in manipulation and facilitated the accomplishment of certain life habits.  Users' increased participation in their life habits may slightly decrease the amount of care-giver assistance needed.  Moreover, these investigators stated that future studies are needed to clarify its economic potential, its impact on care-givers' burden, including paid care-givers, and the variability in the tasks performed using Jaco.

Obi Robotic-Assisted Feeding Device

Obi is a robotic-assisted feeding device that allows patients with limited UE strength and mobility to feed themselves.  The Obi robotic-assisted feeding device can be controlled by any part of the body (e.g., breath, foot, hand, or head) that can activate an accessibility switch.  Currently, there is no published evidence that reported the clinical value of the Obi robotic-assisted feeding device.

Trexo Home Robotic-Assisted Gait Trainer

Diot et al (2021) noted that with few therapeutic options available for non-ambulatory children with CP, a robotic lower extremity (LE) gait trainer may provide a non-invasive addition to conventional therapeutic options.  In a prospective, single-case study, these investigators examined the impact of robotic LE gait trainer use in an individual with CP over the initial 3 months of use.  This study entailed a 7-year-old girl (gross motor function classification system [GMFCS] V) with CP.  The subject used a Trexo Home robotic gait trainer (Trexo) in the community with assessments occurring in the home and school.  Trexo usage and bowel movements (BMs) were tracked daily.  Postural control and LE ROM and spasticity were assessed before Trexo use and weekly to bi-weekly thereafter.  The subject used the device an average of 46 mins/week, over 3.3 days/week; BM frequency increased from 0.4/day at baseline, to 1.2 (± 0.5)/day during Trexo use.  There were no diffuse systematic changes in postural stability, ROM or muscle spasticity; however, specifically head control and spasticity in the knee flexors had improvements.  The authors concluded that data and anecdotal reports suggested that regular use of the Trexo Home robotic gait trainer has positive outcomes on frequency and quality of BMs, and may improve head control, and knee flexor spasticity.  Moreover, these researchers stated that larger controlled studies are needed to examine the impacts of Trexo use in children with CP.

Diot et al (2023) stated that robotic gait training has the potential to improve secondary health conditions for individuals with severe neurological impairment.  In a prospective, observational, single-cohort study, these researchers described who is using the Trexo robotic gait trainer, how much training is achieved in the home and community, and what impacts were observed following the initial month of use.  They collected parent-reported questionnaires pre- and post-training.  Of the 70 participants, the median age was 7 years (range of 2 to 24), 83 % had CP, and 95 % did not walk for mobility.  Users trained 2 to 5 times/week.  After the initial month, families reported a significant reduction in sleep disturbance (p = 0.0066).  Changes in BMs, positive affect, and physical activity were not statistically significant.  These findings suggested that families with children who have significant mobility impairments could use a robotic gait trainer frequently in a community setting and that sleep significantly improved within the 1st month of use.  The authors concluded that the Trexo home robotic-assisted gait trainer holds promise as a novel strategy to impact multi-modal impairments for this population.  Moreover, these researchers stated that future research should include longer-term follow-up to examine if changes observed in the initial month would persist and if there are any impacts, such as improvements in functional ability, that would not be reasonably expected to be observed after only 4 weeks.  Objective measures of physical activity would add meaningful information.  Furthermore, an experimental rather than observational study design would support consistent Trexo use and shed light on the relationship between usage and its impacts.

The authors stated that this study had several drawbacks.  First, there was a potential for bias with parent proxy questionnaires since there was a significant financial investment in purchasing or leasing the Trexo, such that parents were likely to want to see that it helped their child.  Second, the variable timing of when parents completed the questionnaires.  Several participants did not have a baseline evaluation completed until 1 to 2 weeks after starting training with the Trexo, which may have diminished the amplitude of change observed.  Third, early participants who did not have questions appeared as a forced response; therefore, some scores were not completed.  Functional mobility scale (FMS) responses were unclear in the interpretation of the option “uses a wheelchair”, where several parent proxies selected this response when the child was pushed in a wheelchair by another individual (in which case the correct response would be “does not complete the distance”.  In cases where this was unable to be clarified, an FMS score of 1 (“uses a wheelchair”) was excluded.

Walkbot Robotic-Assisted Gait Trainer

Olmos-Gomez et al (2024) noted that improving walking ability is a main objective in the treatment of children and adolescents with CP, since it directly affects their activity and participation.  In recent years, robotic technology has been implemented in gait treatment, which allows training of longer duration and repetition of the movement.  These researchers examined the effectiveness of the Walkbot robotic-assisted gait trainer combined with physiotherapy compared to the isolated physiotherapy for the treatment of children and adolescents with CP.  A total of 23 subjects were divided into 2 groups: experimental and control.  For 5 weeks , both groups received their scheduled physiotherapy sessions; and the experimental group received 4 sessions per week of 40-min of robotic gait training.  Assessments of the participants were performed before the intervention, at the end of the intervention, and at follow-up (2 months after the end of the intervention).  Gait was evaluated with the GMFM-88 dimensions D and E, strength was measured with a hydraulic dynamometer, and ROM was assessed using the goniometer.  A mixed ANOVA was carried out when the assumptions of normality and homoscedasticity were met, and a robust mixed ANOVA was performed when these assumptions were not met.  Statistical significance was stipulated at p < 0.05.  For the effect size, η2 was calculated.  Significant differences were observed regarding the time x group interaction in the GMFN-88 in dimension D [η2 = 0.016], in the flexion strength of the left [η2 = 0.128] and right [η2 = 0.142] hips, in the extension strength of the right hip [η2 = 0.035], in the abduction strength of the left hip [η2 = 0.179] and right [η2 = 0.196], in the flexion strength of the left knee [η2 = 0.222] and right [η2 = 0.147], and in the ROM of left [η2 = 0.071] and right [η2 = 0.053] knee flexion.  The authors concluded that compared to treatments without walking robot, physiotherapy treatment including Walkbot improved standing, muscle strength, and knee ROM in children and adolescents with CP.  Moreover, these investigators stated that in future research, it would be advisable to carry out RCTs, with homogeneous groups in terms of levels of impairment in the GMFCS- Expanded & Revised (GMFCS-ER), and with larger samples.  It would also be convenient to compare the treatment with specific physiotherapy treatments, and to contrast whether treatment times are shortened by including the use of the Walkbot.

The authors stated that this study had 2 key drawbacks.  First, the groups were not randomized, since participants who were willing to travel to the place where the treatment was carried out were assigned to the group experiment, and the final sample size was reduced compared to what was expected.  Second, these researchers have evaluated variables related to body structure, function and activity, but not to participation, according to the International Classification of Functioning, Disability and Health (ICF) framework.

References