Description:
Suit therapy has been proposed as an alternative to conventional physiotherapy to treat the impairments associated with cerebral palsy. Originally designed by the Russian government for use by cosmonauts in space to minimize the effects of weightlessness, the principle is to move body parts against a resistance, thus improving muscle strength. It is thought that through placement of the elastic cords, selected muscle groups can be exercised as the patient moves limbs, providing a form of controlled exercise against a resistance. Additionally, it is claimed that the suit improves coordination. When suit therapy is used, it may be part of a comprehensive program of intensive physiotherapy that includes 5 – 7 hours a day for four weeks.

Suit therapy first began in clinics in Europe in the early 1990s and spread to the United States. Suit therapy is currently provided at many physical therapy centers in the United States. After suit therapy is rendered at a facility, a suit or suit therapy device may be available for purchase in order to continue with home therapy. There are numerous suit therapy options available. These include, but are not limited to the Adeli^® suit; the TheraSuit^™; the NeuroSuit; and TheraTogs^™. The NeuroSuit consist of a breathable material and includes a hat, vest, shorts, knee pads, elbow pads and gloves. The TheraSuit includes a cap, vest, shorts, knee pads, arm attachments and shoe attachments, with the pieces connected by elastic bands. TheraTogs include a sleeveless tank top, hipster, extremity cuffs, elasticized straps, extra hook tabs, double-grip hook with loop material and position-marking dots.

Although Suit Therapy has primarily been utilized for treatment of cerebral palsy, there have been numerous other suggested uses by the manufacturers and providers. These uses include, but are not limited to: treatment of other neuromuscular disorders, including developmental delays, traumatic brain injury, ataxia, athetosis, spasticity, hypotonia and gait retraining after stroke.

Treatment includes the use of a specially designed suit in combination with intensive daily therapy. Three principles form the basis of this treatment:

1. The effect of the suit as it works against resistance loads and increases realignment
2. Intensive daily therapy for up to five hours per day for three-four weeks
3. Active motor participation by the patient

The design of the different suits may vary, but the concept of the treatment is to move body parts against resistance, thereby improving muscle strength. A wide belt with rings is worn at the hips. Elastic cords attached through the rings provide compression to body joints and resistance to the muscles when the patient moves.

Policy:
Suit Therapy (also known as the Adeli Suit, Penguin Suit, Polish Suit, Stabilizing Pressure Input Orthoses, Therapy Suit, Therasuit and TheraTogs) is considered INVESTIGATIONAL for all indications, including, but not limited to: cerebral palsy, neuromuscular conditions and gait rehabilitation following stroke.

Rationale
Literature Review
Bailes et al. (2011) conducted a randomized controlled trial to examine the effects of suit wear during an intensive therapy program on motor function among 20 children with cerebral palsy. The children were randomized to an experimental (TheraSuit) or a control (control suit) group and participated in an intensive therapy program. The Pediatric Evaluation of Disability Inventory (PEDI) and Gross Motor Function Measure (GMFM) — 66 were administered before and after treatment (four and nine weeks) with parent satisfaction also assessed. There were no significant differences found between the groups. There were significant within-group differences found for the control group on the GMFM-66 and for the experimental group on the GMFM-66, PEDI Functional Skills Self-care, PEDI Caregiver Assistance Selfcare and PEDI Functional Skills Mobility. The authors concluded the children wearing a therasuit during an intensive therapy program did not demonstrate improved motor function compared to those wearing a control suit during the same program.

Bar-Haim et al. (2006) conducted a randomized study of 24 children that compared the efficacy of Adeli suit treatment (AST) with neurodevelopmental treatment (NDT) in children with cerebral palsy. In the AST group (n = 12) six children had spastic/ataxic diplegia, one triplegia and five had spastic/mixed quadriplegia. In the NDT group (n = 12) five children had spastic diplegia and seven had spastic/mixed quadriplegia. Treatment was for two hours daily, five days per week over four weeks for a total of 20 sessions. Outcome measurements included the Gross Motor Function Measure (GMFM-66) and the mechanical efficiency index (EIHB). These were measured during stair-climbing, at baseline, immediately after one month of treatment and 10 months after baseline. There was an increase in both the GMFM-66 and EIHB noted at one month for both intensive physiotherapy courses. This increase appeared to be greater than expected from natural maturation of children with cerebral palsy at this age. It was noted that the improvements in motor skills and their retention nine months after treatment were not significantly different between the two treatment modes. A post hoc analysis indicated a greater increase in EIHB after one month and 10 months in the AST group than that in the NDT group. This was noted to be more predominant in the children with higher motor function. The investigators conclude that: "The results suggest that AST might improve mechanical efficiency without a corresponding gain in gross motor skills, especially in children with higher levels of motor function." The investigators also note that, "Future studies on the efficacy 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 [cerebral palsy] to reduce variability."

Liptak (2005) conducted a review of nine complementary and alternative therapies for cerebral palsy, including the Adeli suit, and noted "no published evidence from a controlled trial is available in English to support or reject the use of the suit. Thus, no conclusive evidence either in support of or against the use of the Adeli suit is available."

Professional Societies/Organizations
The Cerebral Palsy International Research Foundation (CPIRF) published two research fact sheets on the Adeli suit. The first was published in March 1999. At that time, suit therapy was only being provided at centers in Poland. Interest in suit therapy inspired a second fact sheet in November 2004. The 2004 UCP fact sheet reported on two studies funded by the CPIRF. The first study noted in the UCP research fact sheet involved 24 children randomly assigned to either a standard physical therapy program or to the Adeli suit using the original Russion protocol. Both groups were treated with a two-hour session, five days a week. Evaluation of a number of parameters showed marginal improvement in both groups that persisted over the following year. There was no statistical difference between the children who used the Adeli suit and those who did not (CPIRF, 2004). The second study noted in the fact sheet included 57 children who were randomized to control and treatment groups. All children received one hour each of physical, occupational and speech therapy three times a week for 8 – 10 weeks, followed by a four-week home program. The experimental group wore the Adeli suit for the last four weeks of their therapy program. It was noted that both groups improved and sustained the improvement but without any statistical difference between the two groups (CPIRF, 2004). The research fact sheet concluded that these studies show that a period of intensive therapy in ambulatory children with cerebral palsy can lead to improvement in a number of disabilities. They did not, however, demonstrate that the Adeli suit was helpful and indicated that any effect was likely to have been minor.

Summary
There is insufficient evidence in the published, peer-reviewed scientific literature to establish the safety and effectiveness of suit therapy or the home use of a suit therapy device for the treatment of functional impairments associated with cerebral palsy, other neuromuscular disorders or other medical conditions. Well-designed clinical trials are needed to demonstrate that this treatment is as effective as conventional physical therapy in the treatment of cerebral palsy or other neuromuscular disorders, that it improves patients' functional abilities and activities of daily living and that it decreases impairment in the participants.

References:

1. Adeli Project [information on the Adeli approach]. Ayurveda JS Co. Accessed March 12, 2013. 
2. Adeli Suit [product information]. Euromed. Accessed March 12, 2013.
3. Anttila H, Autti-Rämö I, Suoranta J, Mäkelä M, Malmivaara A. Effectiveness of physical therapy interventions for children with cerebral palsy: a systematic review. BMC Pediatr. 2008 Apr 24;8:14.
4. Ashwal S, Russman BS, Blasco PA, Miller G, Sandler A, Shevell M, Stevenson R; Quality Standards Subcommittee of the American Academy of Neurology; Practice Committee of the Child Neurology Society. Practice parameter: diagnostic assessment of the child with cerebral palsy: report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2004 Mar 23;62(6):851-63. (guideline was reaffirmed by the developer on July 21, 2007)
5. Bailes AF, Greve K, Schmitt LC. Changes in two children with cerebral palsy after intensive suit therapy: a case report. Pediatr Phys Ther. 2010 Spring;22(1):76-85.
6. Bailes AF, Greve K, Burch CK, Reder R, Lin L, Huth MM. The effect of suit wear during an intensive therapy program in children with cerebral palsy. Pediatr Phys Ther. 2011 Summer;23(2):136-42.
7. Bar-Haim S, Harries N, Belokopytov M, Frank A, Copeliovitch L, Kaplanski J, Lahat E. Comparison of efficacy of Adeli suit and neurodevelopmental treatments in children with cerebral palsy. Dev Med Child Neurol. 2006 May;48(5):325-30.
8. Cerebral Palsy International Research Foundation (CPIRF). The Adeli Suit [research fact sheet: diagnosis/treatment]. March 1999. Accessed March 12, 2013.
9. Cerebral Palsy International Research Foundation (CPIRF). The Adeli Suit Update [research fact sheet]. 2004 Nov. Accessed March 12, 2013. 
10. Cooley WC; American Academy of Pediatrics Committee on Children With Disabilities. Providing a primary care medical home for children and youth with cerebral palsy. Pediatrics. 2004 Oct;114(4):1106-13.
11. Flanagan A, Krzak J, Peer M, Johnson P, Urban M. Evaluation of short-term intensive orthotic garment use in children who have cerebral palsy. Pediatr Phys Ther. 2009 Summer;21(2):201-4.
12. Goldstein M. The treatment of cerebral palsy: what we know, what we don't know. J Pediatr. 2004 Aug;145(2 Suppl):S42-6.
13. Hurvitz EA, Leonard C, Ayyangar R, Nelson VS. Complementary and alternative medicine use in families of children with cerebral palsy. Dev Med Child Neurol. 2003 Jun;45(6):364-70.
14. Kliegman RM, Stanton BF, St. Geme III JW, Schor NF, Behrman RE, editors. Nelson textbook of pediatrics, 19th ed. Philadelphia, PA: W.B. Saunders Company; 2011.
15. Liptak GS. Complementary and alternative therapies for cerebral palsy. Ment Retard Dev Disabil Res Rev. 2005;11(2):156-63.
16. Michaud LJ; American Academy of Pediatrics Committee on Children With Disabilities. Prescribing therapy services for children with motor disabilities. Pediatrics. 2004 Jun;113(6):1836-8. (Statement of reaffirmation for this policy published on September 1, 2007; July 1, 2011). Accessed March 12, 2013. 
17.  NINDS cerebral palsy information page. Cerebral Palsy: Hope Through Research. National Institute of Neurological Disorders and Stroke (NINDS). Bethesda, MD: NINDS, National Institutes of Health (NIH). Last updated August 23, 2012. Accessed March 12, 2013.
18. NOMC [North Oakland Medical Centers] Euro-Pēds program: SUIT therapy. Accessed March 12, 2013. 
19. Oppenheim WL. Complementary and alternative methods in cerebral palsy. Dev Med Child Neurol. 2009 Oct;51 Suppl 4:122-9.
20. Richards A, Morcos S, Rethlefsen S, Ryan D. The use of TheraTogs versus twister cables in the treatment of in-toeing during gait in a child with spina bifida. Pediatr Phys Ther. 2012 Winter;24(4):321-6.
21. Rosenbaum P. Cerebral palsy: what parents and doctors want to know. BMJ. 2003 May 3;326(7396):970-4.
22. Suit therapy for cerebral palsy [information about the TheraSuit Method™ and the TheraSuit™]. Therasuit LLC. Accessed March 12, 2013.
23. TheraTogs [product information]. TheraTogs, Inc. Accessed March 12, 2013. 
24. United Cerebral Palsy (UCP). The Treatment of Cerebral Palsy [research status report]. Washington, DC: United Cerebral Palsy (UCP) Research & Educational Foundation; 2003 Jun.
25. U.S. Food and Drug Administration (FDA). Code of federal regulations; title 21, vol. 8; subchapter H (medical devices); part 890 (physical medicine devices); subpart D (physical medicine prosthetic devices); sec. 890.3475]. Limb orthosis. Revised as of April 1, 2008. Accessed March 12, 2013. 
26. Weisleder P. Unethical prescriptions: alternative therapies for children with cerebral palsy. Clin Pediatr (Phila). 2010 Jan;49(1):7-11.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

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History From 2024 Forward     

07/10/2024 Annual review, no change to policy intent 

01/01/2024 NEW POLICY