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Background
The Adeli Suit (also known as the Polish Suit, Therapy Suit, Penguin Suit, and Therasuit) is a modification of a space suit, called the “Penguin” suit used by Russian cosmonauts to counter the effects of long-term weightlessness on the body while in space. The inner workings of the suit have elastic bands and pulleys that created artificial force against which the body could work to help prevent muscle atrophy and osteoporosis.
Although the cause of motor dysfunction between cerebral palsy patients and astronauts are different, results of a treatment trial with the Penguin suit to rehabilitate patients with cerebral palsy appeared promising. The Penguin suit was then modified resulting in an elasticized suit for use in positioning and stretching muscles during physical therapy. Suit therapy for cerebral palsy is currently available at the Euromed Clinic in Poland and at several other centers in Europe and the United States. The Adeli Suit is used in the Polish facility as part of a comprehensive program of intensive physiotherapy administered 5 to 7 hours per day for 5 to 6 days a week for 4 weeks.
According to the Euromed Rehabilitation Center website: "The Adeli Suit consists of a vest, shorts, knee pads and specially adapted shoes with hooks and elastic cords that help tell the body how it is supposed to move in space. Therapists use the Adeli Suit to hold the body in proper physical alignment. During specialized exercises, the therapists adjust the elastic connectors that topographically mirror flexor and extensor muscles, trunk rotators and the lower limbs. Additional attachments correcting the position of the feet, head and other areas of the body have also been designed. A patient, while wearing the Adeli Suit, goes through various exercises including "how to walk". The Suit works as an elastic frame surrounding the body and does not limit the amplitude of movement but adds an additional weight load on it within designed limits."
There are published anecdotal reports (the majority of which are published in the Russian language) of children gaining in speech, fine motor control, as well as movement with suit therapy, but no randomized controlled clinical trials of suit therapy have been published. The U.S. Food and Drug Administration has classified the Adeli Suit and other similar devices as a class 1 limb orthosis (brace). Thus the Adeli Suit is exempt from the premarket notification procedures of the FDA and the manufacturer is not required to provide evidence of efficacy prior to marketing.
Enough interest has been generated by anecdotal and verbal reports that the United Cerebral Palsy (UCP) Research and Educational Foundation funded two studies on suit therapy. While the results of these studies are not yet available in the peer-reviewed published medical literature, the UCP Research and Educational Foundation website is making the information available due to the current interest in suit therapy.
The first study by Dr. Alexander Frank and associates at the Motion Analysis Laboratory, Assaf Harofeh Medical Center, Zerifin, Israel, reported the results of 24 children who had cerebral palsy and a functional level of II, III or IV according to the Gross Motor Function Classification System. The patients were randomly assigned to either a standard physical therapy program or to the Adeli Suit. Both groups were treated 5 days per week for 2 hours. Marginal improvement was noted in both groups without any statistical difference in results between the 2 groups.
A second study by Dr. Edward Dabrowski at the Children's Hospital of Michigan reported the results of 57 children, all of whom received an hour of physical, occupational, and speech therapy 3 times a week for 8-10 weeks followed by a 4-week home program. The experimental group wore the Adeli Suit for the last 4 weeks of their therapy program. Both groups improved and sustained their improvement without any statistical difference in results between the 2 groups. The United Cerebral Palsy Foundation concluded that "[t]hese studies show that a period of intensive therapy in ambulatory children with cerebral palsy can lead to improvement in a number of disabilities. However, they did not demonstrate that use of the Adeli Suit was helpful. Any effect is likely to be minor."
Controlled clinical studies are necessary to determine the beneficial effects of suit therapy, if any, for the treatment of cerebral palsy, especially which patients would benefit the most and how long any beneficial results would last.
Liptak (2005) reviewed nine treatment modalities used for children who have CP including the Adeli Suit, The author noted that no conclusive evidence either in support of or against the use of the Adeli suit is available.
Bar-Haim and colleagues (2006) compared the effectiveness of Adeli suit treatment (AST) with neurodevelopmental treatment (NDT) in children with CP. A total of 24 children with CP, Levels II to IV according to the Gross Motor Function Classification System (GMFCS), were matched by age and functional status and randomly assigned to the AST or NDT treatment groups. In the AST group (n = 12; 8 males, 4 females; mean age of 8.3 years [SD 2.0]), 6 children had spastic/ataxic diplegia, 1 triplegia and 5 spastic/mixed quadriplegia. In the NDT group (n = 12; 9 males, 3 females; mean age of 8.1 years [SD 2.2]), 5 children had spastic diplegia and 7 had spastic/mixed quadriplegia. Both groups were treated for 4 weeks (2 hours daily, 5 days per week, 20 sessions). To compare treatments, the Gross Motor Function Measure (GMFM-66) and the mechanical efficiency index (EIHB) during stair-climbing were measured at baseline, immediately after 1 month of treatment, and 10 months after baseline. The small but significant time effects for GMFM-66 and EIHB that were noted after 1 month of both intensive physiotherapy courses were greater than expected from natural maturation of children with CP at this age. Improvements in motor skills and their retention 9 months after treatment were not significantly different between the two treatment modes. Post hoc analysis indicated a greater increase in EIHB after 1 month (p = 0.16) and 10 months (p = 0.004) in AST than that in NDT, predominantly in the children with higher motor function (GMFCS Levels II and III). The results suggested that AST might improve mechanical efficiency without a corresponding gain in gross motor skills, especially in children with higher levels of motor function. These investigators also stated that "[f]uture studies on the effectiveness of AST should measure changes in metabolic efficiency and fitness level, as well as motor skills. It is also important to determine changes induced by the suit itself, by having two groups perform the same physical training, with and without the suit. Future studies should increase the number of participants and homogenize the participants with CP to reduce variability….".
TheraTogs (TheraTogs, Inc., Telluride, CO) are an orthotic undergarment that consist of a two-piece body suit and a strapping system that is customized for the child. TheraTogs are worn every day and, according to the manufacturer's website, are indicated for children with a variety of disorders, including ataxia, athetosis, low muscle tone, poor postural alignment and joint deviations. There is a lack of evidence of the effectiveness of TheraTogs in the peer-reviewed, published medical literature.
Stabilizing Pressure Input Orthoses (SPIO) are made from a Lycra-like blend material that are intended to provide deep pressure through compression to improve positional limb and body awareness, core muscle and joint stabilization, and increase precision of muscle activation and movement.
Hylton and Allen (1997) stated that the use of flexible compression bracing in persons with neuromotor deficits offers improved possibilities for stability and movement control without severely limiting joint movement options. This treatment modality has been explored with increasing application in children with moderate to severe cerebral palsy (CP) and other neuromotor deficits with good success. Significant functional improvements using Neoprene shoulder/trunk/hip bracing led these researchers to experiment with much lighter compression materials. The stabilizing pressure input orthosis (SPIO) bracing system is custom-fitted to the stability, movement control and sensory deficit needs of a specific individual. The SPIO bracing system supposedly can provide an improved base of support for functional gains in balance, dynamic stability, general and specific movement control with improved postural and muscle readiness. However, there is currently insufficient evidence to support the effectiveness of SPIO.
Autti-Rämö and colleagues (2006) reviewed the evidence on the effectiveness of using upper and lower limb casting or orthoses in children with CP. These researchers used computerized bibliographic databases to search for systematic reviews without any language restrictions. Identification, selection, quality assessment, and data extraction were performed independently by 2 investigators. Of the 40 identified reviews, 23 were selected for closer consideration, and 5 reviews met the inclusion criteria. The quality of existing systematic reviews and original studies included in the review varied widely. The following evidence was found: (i) casting of lower limbs has a short-term effect on passive range of movement; (ii) orthoses that restrict ankle plantar flexion have a favorable effect on an equinus walk, but the long-term clinical significance is unclear; (iii) evidence on managing upper limb problems with casting or splinting in children with CP is inconclusive. The author concluded that there is a paucity of evidence from primary studies on the use of orthoses in children with CP. They stated that more original, well-designed research is needed.
Available evidence does not demonstrate durable benefits from the use of suit therapy for cerebral palsy (NHS QIS, 2005; NHSC, 2002).
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