Dynamic movement orthoses (suit therapy)

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Clinical Policy Title: Dynamic movement orthoses (suit therapy)

Clinical Policy Number:

Effective Date:

Initial Review Date:

14.02.05

October 1, 2015

June 17, 2015

Most Recent Review Date: July 21, 2015

Next Review Date: June 2016

Related policies: None

Policy contains:

• Dynamic movement orthoses

(suit therapy) for motorrelated problems in children, especially those with cerebral palsy.

ABOUT THIS POLICY: Select Health of South Carolina has developed clinical policies to assist with making coverage determinations. AmeriHealth VIP Care’ clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by Select Health of South Carolina when making coverage determinations.

In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth VIP Care’ clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth VIP Care’ clinical policies are reflective of evidencebased medicine at the time of review. As medical science evolves, Select Health of South Carolina will update its clinical policies as necessary. AmeriHealth VIP Care’ clinical policies are not guarantees of payment.

Coverage policy

Select Health of South Carolina considers the use of dynamic movement orthoses (suit therapy) to be investigational and not clinically proven, and therefore, not covered.

Limitations:

None

Alternative covered services:

None

Background

Dynamic movement orthoses (DMO), also known as suit therapy, is a treatment administered to patients with motor dysfunctions. Most frequently, suit therapy is used for children with

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cerebral palsy (CP) who typically have problems with gait and other aspects of movement.

While motor functions of many body parts can be improved by orthoses, this review will focus on lower limbs.

There are a variety of suits available for such treatment. They include stabilizing pressure input orthosis (SPiO), the Adeli suit, the Penguin suit, the Polish suit, the Therapy suit, the

Thera suit and TheraTogs. Garments can include vests, shirts, pants shorts, unitards, abdominal wraps, arm and leg wraps, and compression gloves. The garments are designed to essentially “inform” the patient’s body how to correctly move, by changing positions of certain body parts and adding additional weight.

Intensive physiotherapy is sometimes given to children suffering from certain motor-related disorders, with CP being the most common of these. Treatment tends to be short-term, i.e., several weeks, featuring a daily regimen of several hours per day.

DMOs/suit therapy products have been approved for use by the U.S. Food and Drug

Administration (FDA). However, these devices are typically considered class 1 orthoses, which means the manufacturer is not required to inform the FDA on efficacy.

Searches

Select Health of South Carolina searched PubMed and the databases of:

• UK National Health Services Centre for Reviews and Dissemination.

• Agency for Healthcare Research and Quality’s National Guideline Clearinghouse and other evidence-based practice centers.

• The Centers for Medicare & Medicaid Services (CMS).

We conducted searches in May 2015. USearch terms were: “Adeli suit”, “Penguin suit,” “Polish suit,” “SPiO/stabilizing pressure input orthoses,” “suit therapy,” “Thera suit,” “TheraTogs” and

“Therapy suit.”

We included:

Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies.

Guidelines based on systematic reviews.

Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes — sometimes referred to as efficiency studies — which also rank near the top of evidence hierarchies.

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Findings

Earliest studies: Caregivers have been using various forms of suit therapy for decades. As early as 1999, United Cerebral Palsy reported on randomized controlled trials (RCTs) in the Assef

Harofeh Medical Center in Israel and Children’s Hospital in Michigan on children with CP.

While these studies were never published in the peer-reviewed literature, they showed only marginal differences in improvement in children with CP who wore Adeli suits (United

Cerebral Palsy (UCP) Research & Education Foundation).

RCTs: A search of the medical literature found seven RCTs on suit therapy, all subsequent to the initial studies in Israel and Michigan. One of these was just a description of methods, with no results as of May 2015. The trials included a relatively small number of participants (13, 20,

24, 30, 36 and 57).

Some of these reports documented efficacy, i.e., some showed suit therapy to improve gait and other motor functions compared to baseline and controls. One study showed improvement in gait using TheraTogs, a type of suit therapy, and orthoses in children with CP (El Kafy).

Another showed that TheraTogs and hip abductor taping significantly improved gait speed and hip abductor activity in stroke patients (Maguire 2010). Alagesan and Khayatzdeh both found significantly greater improvement in gross motor function among children with CP using modified suit therapy.

But Bailes found no significant difference in gross motor function measure (GMFM) change between CP children wearing TheraSuits and controls. Bar-Haim found no significant differences in GMFM improvement between CP children wearing Adeli suits versus controls, but did find significantly greater improvements in Mechanical Efficiency Index (EIHB).

Pitchay published conference proceedings in 2012, using eight studies of suit therapy on children with children with CP; only two of these were RCTs. Of the eight reports, all but one supported the use of suit therapy to improve functional outcomes, gait analysis, posture, walking speed and mechanical efficiency.

Other studies: Additional studies that are not RCTs analyzed changes in motor functions for children with CP. Two of these reviewed use of TheraSuit (Christy) and TheraTog garments

(Flanagan); the former found improvement in GMFM, but not in walking amount or intensity, while the latter found improved gait. Matthews identified greater gait velocity in five of eight subjects and consistency (four of eight subjects) with CP that used dynamic elastomeric fabric orthoses.

Other articles that focused on a single child with CP found improvements in gait, GMFM, and balance (Ko) and in-toeing (Richards).

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Glossary

Adeli suit — One of several suits to improve movement, often in children with CP.

Cerebral palsy (CP) — A disorder of the brain, typically beginning in pregnancy or soon after birth, affecting movement, balance and posture.

Dynamic movement orthoses (DMO) — A garment used to improve movement, typically walking and gait, in children with motor-related disorders.

Gross motor function measure — A means of calculating motor function, often used in studies of suit therapy.

Suit therapy — See dynamic movement orthoses.

Professional society guidelines/other:

None

Peer-reviewed references:

Abd El-Kafy EM. The clinical impact of orthotic correction of lower limb rotational deformities in children with cerebral palsy: a randomized controlled trial. Clin Rehabil . October 2014;

28(10): 10,004 – 10,014.

Alagesan J, Shetty A. Effect of modified suit therapy in spastic diplegic cerebral palsy — a single blinded randomized controlled trial. Online J Health Allied Sci . October – December 2010; 9(4):

1 – 3.

Bailes AF, Greve K, et al. The effect of suit wear during an intensive therapy program in children with cerebral palsy. Pediatr Phys Ther Summer 2011; 23(2): 136 – 142.

Bar-Haim S, Harries N, et al. Comparison of efficacy of Adeli suit and neurodevelopmental treatments in children with cerebral palsy. Dev Med Child Neurol . May 2006; 48(5): 325 – 330.

Christy JB, Chapman CG, et al. The effect of intense physical therapy for children with cerebral palsy. J Pediatr Rehabil Med . 2012; 5(3): 159 – 170.

Flanagan A, Krzak J, et al. Evaluation of short-term intensive orthotic garment use in children who have cerebral palsy. Pediatr Phys Ther. Summer 2009; 21(2): 201 – 204.

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Hylton N, Allen C. The development and use of SPIO Lycra compression bracing in children with neuromotor deficits. Pediatr Rehabil . April – June 1997; 1(2): 109 – 116.

Khayatzdah Mahani M, Harimloo M, et al. Effects of modificed Adeli suit therapy on improvement of gross motor function in children with cerebral palsy. Hong Kong J Occup Ther .

2011; 21(1): 9 – 14.

Ko MS, Lee JA, et al. Effect of Adeli suit treatment on gait in a child with cerebral palsy: a singlesubject report. Physiother Theory Pract . May 2015; 31(4): 275 – 282.

Liptak GS. Complementary and alternative therapies for cerebral palsy. Ment Retard Dev Disabil

Res Rev . 2005; 11(2): 156 – 163.

Maguire C, Sieben JM et al. Hip abductor in walking following stroke — the immediate effect of canes, taping, and TheraTogs on gait. Clin Rehabil . January 2010; 24(1): 37 – 45.

Maguire C, Sieben JM, et al. How to improve walking, balance and social participation following stroke: a comparison of the long term effects of two walking aids — canes and an orthosis

TheraTogs — on the recovery of gait following acute stroke. A study protocol for a multicentre, single blind, randomized control trial. BMC Neurol . March 2012; 30: 12 – 18.

Matthews MJ, Watson M, et al. Effects of dynamic elastomeric fabric orthoses on children with cerebral palsy. Prosthet Orthot Int.

December 2009; 33(4): 339 – 347.

Richards A, Morcos S, et al. The use of TheraTogs versus twister cables in the treatment of intoeing during gait in a child with spina bifida. Pediatr Phys Ther . Winter 2012; 24(4): 321 –

326.

Rosenbaum P. Controversial treatment of spasticity: exploring alternative therapies for motor function in children with cerebral palsy. J Child Neurol . September 2003; 18 Suppl 1: S89094.

Other references:

Pitchay S, Remedios C. Effectiveness of suit therapy on children with cerebral palsy: A literature review. 6th Biennial Conference of the Australasian Academy of Cerebral Palsy and

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Developmental Medicine, Brisbane, Australia. May 30 – June 2, 2012. Blackwell Publishing Inc.,

1 – 86.

United Cerebral Palsy (UCP) Research & Education Foundation. The Adeli Suit, 3/99. Research

Fact Sheets: Diagnosis/Treatment. Washington, DC: UCP; March 1999.

United Cerebral Palsy (UCP) Research & Education Foundation. New: The Adeli Suit Update,

11/2004. Research Fact Sheets. Washington, DC: UCP; November 2004.

Summary of clinical evidence

Citation

Randomized controlled trials

El-Kafy

(2014)

Maguire

(2012)

Content

Key points:

• N=57, CP, 12 weeks Rx, measures gait speed, cadence, stride length.

• No orthotic management, TheraTogs only, TheraTogs and ankle foot orthoses groups.

• TheraTogs and ankle foot orthoses had greatest improvement in gait.

Key points:

• N=120, post-stroke, five weeks Rx, measures gait, balance, social participation.

• TheraTogs and cane groups.

• No results as of May 2015.

Bales (2011) Key points:

• N=20, CP, nine weeks Rx, measures GMFM-66.

Khayatzdeh

(2011)

• TheraSuit and control suit groups.

• No significant differences found between groups.

Key points:

• N=36, CP, measures GMFM.

Alagesan

(2010)

Maguire

(2010)

• Modified Adeli suit therapy, Adeli suit therapy, neurodevelopment therapy.

• All show significant improvement, especially MAST.

Key points:

• N=30, CP, three weeks Rx, measures GMFM-88.

• Modified suit therapy + physiotherapy significantly greater improvements.

Key points:

• N=13, stroke, six gait cycle Rx, hemiplegic hip abductor activity and gait speed.

• Hip abductor taping, TheraTogs, cane in non-hemiplegic hand.

• Hip abductor taping and TheraTogs showed significantly better

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Bar-Haim

(2006) progress.

Key points:

• N=24, CP, four weeks Rx, GMFM-66 and mechanical efficiency index

(EIHB).

• Adeli Suit, neurodevelopmental treatment.

• No significant difference in GMFM.

• Significantly greater improvement in EIHB for Adeli suit group.

Related policies:

Select Health of South Carolina Utilization Management program description.

CMS National Coverage Determinations (NCDs):

No NCDs identified as of the writing of this policy.

Local Coverage Determinations (LCDs):

No LCDs identified as of the writing of this policy.

Commonly Submitted Codes

Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy.

This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill in accordance with those manuals.

CPT Code Description Comment

NA No specific CPT code

ICD-9 Code

343.0

343.2

343.3

343.4

343.8

343.9

ICD-10

Code

G80.1

G80.0

G80.2

Description

Diplegic infantile cerebral palsy

Quadriplegic infantile cerebral palsy

Monoplegic infantile cerebral palsy

Infantile hemiplegia

Other specified infantile cerebral palsy

Infantile cerebral palsy, unspecified

Description

Spastic diplegic cerebral palsy

Quadriplegic infantile cerebral palsy

Spastic hemiplegic cerebral palsy

Comment

Comment

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G80.4

G80.8

G80.9

HCPCS

Level II

NA

Ataxic cerebral palsy

Other cerebral palsy

Infantile cerebral palsy, unspecified

Description Comment

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