0696 Suit Therapy Medical Clinical Policy Bulletins

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Suit Therapy

POLICY HISTORY

Last Review: 09/24/2021

Effective: 01/07/2005

Next Review: 07/21/2022

Review History

Definitions

Additional Information Clinical Policy Bulletin

Notes

Number: 0696

POLICY *Please see amendment for Pennsylvania Medicaid at theend of this CPB.

Aetna considers suit therapy or home use of a suit therapy device (also

known as the Adeli Suit, Penguin Suit, Polish Suit, Stabilizing Pressure

Input Orthoses, Therapy Suit, Therasuit, and TheraTogs) experimental

and investigational for the treatment of members with cerebral palsy (CP)

or other conditions (e.g., gait rehabilitation following stroke) because

there is inadequate evidence of the effectiveness of this therapy in the

management of these conditions.

Aetna considers dynamic movement TLSO "brace" (Dynamic Lycra Suit)

experimental and investigational for the treatment of members with CP or

scoliosis because there is inadequate evidence of the effectiveness of

this therapy in the management of these conditions.

Aetna considers Dynamic Movement Orthoses experimental and

investigational for the treatment of members with CP,

hemiparesis/hemiplegia, scoliosis, and all other indications because there

is inadequate evidence of the effectiveness of this therapy in the

management of these conditions.

Aetna considers thoracic lumbar sacral orthosis (TLSO) experimental and

investigational for the treatment of autism because there is a lack

of evidence of the effectiveness of this device in the management of

autism.

Aetna considers the Benik vest/trunk support (Benik dynamic trunk

orthosis) experimental and investigational for individuals with low trunk

tone and all other indications because its effectiveness has not been

established.

See also: CPB 0405 - Mechanical Stretching Devices for Contracture

and Joint Stiffness (../400_499/0405.html).


BACKGROUND The Adeli Suit (also known as the Polish Suit, Therapy 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 (CP)

patients and astronauts are different, results of a treatment trial with the

Penguin suit to rehabilitate patients with CP 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 CP 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 (FDA) 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

(2004) funded 2 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 CP and a functional level of II,

III or IV according to the Gross Motor Function Classification System.

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 1 hour

of physical, occupational, and speech therapy 3 times a week for 8 to 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 UCP 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 CP, especially which

patients would benefit the most and how long any beneficial results would

last.

Liptak (2005) reviewed 9 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 2 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 m easure changes in

metabolic efficiency and fitness level, as well as motor skills. It is also

important to det ermine 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 2-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 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-Ramo 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 s earch 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 r eview 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; and (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 CP (NHSC, 2002; NHS QIS, 2005).

In a case report, Bailes et al (2010) investigated the effects of intensive

suit therapy on gait, functional skills, care-giver assistance, and gross

motor ability in children with CP. Two children with spastic diplegia

classified at level III on the GMFCS participated. Outcomes were

assessed using dimensions D and E of the GMFCS, the Pediatric

Evaluation of Disability Inventory (PEDI), and instrumented gait analysis.

Each child participated in the Therasuit Method, 4 hours a day, 5 days a

week for 3 weeks. Very small improvements in function were noted in

dimension D of the GMFCS and PEDI Self-care Domain with decreased

function in other areas. Improved walking speed, cadence, symmetry,

joint motion, and posture were found with gait analysis. The authors

concluded that further investigation is needed of the suit itself, and

intensive therapy programs in children with CP.

Bailes et al (2011) examined the effects of suit wear during an intensive

therapy program on motor function among children with CP. A total of

20 children were randomized to an experimental (TheraSuit) or a control

(control suit) group and participated in an intensive therapy program. The

PEDI and GMFM-66 were administered before and after (4 and 9

weeks). Parent satisfaction was also assessed. No significant

differences were found between groups. Significant within-group

differences were 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 Self-care, and PEDI Functional Skills

Mobility. No adverse events were reported. The authors concluded that

children wearing the TheraSuit during an intensive therapy program did

not demonstrate improved motor function compared with those wearing a

control suit during the same program.

Maguire et al (2012) presented the protocol of a study designed to

investigate the long-term effects on the recovery of gait, balance and

social participation of gait rehabilitation with TheraTogs compared to gait

rehabilitation with a cane following first time acute stroke. This study will

be a multi-center, single-blind, randomized trial with 120 patients after first

stroke. When subjects have reached Functional Ambulation Category 3

they will be randomly allocated into TheraTogs or cane group. TheraTogs

will be applied to support hip extensor and abductor musculature


according to a standardized procedure. Cane-walking held at the level of

the radial styloid of the sound wrist. Subjects will walk throughout the day

with only the assigned walking aid. Standard therapy treatments and

usual care will remain unchanged and documented. The intervention will

continue for 5 weeks or until patients have reached Functional

Ambulation category 5. Outcome measures will be assessed the day

before beginning of intervention, the day after completion, 3 months, 6

months and 2 years. Primary outcome is Timed "up and go" test;

secondary outcomes are peak surface electromyography of gluteus

maximus and gluteus medius, activation patterns of hemiplegic leg

musculature, temporo-spatial gait parameters, hemiplegic hip

kinematics in the frontal and sagittal planes, dynamic balance, daily

activity measured by accelerometry, Stroke Impact Scale. Significance

levels will be 5 % with 95 % confidence intervals. Intentio-t-treat

analyses will beperformed.

Descriptive statistics will be presented. The authors concluded that this

study could have significant implications for the clinical practice of gait

rehabilitation after stroke, particularly the effect and appropriate use of

walking aids. The results could be important for the development of

clinical guidelines and for the socio-economic costs of post-stroke care.

In a case-study, Matthews and Crawford (2006) noted that treatment of

scoliosis has been under discussion in relation to surgical intervention

since the Boston brace was presented by Hall in 1976. The effects of

rigid bracing on thoracic skeletal integrity and the possible deformation of

ribs due to the high localized pressure due to prolonged wear have been

high-lighted. The lack of compliance has encouraged clinicians to

examine other options for non-surgical treatment. The Spinecor and

Triac bracing systems have been developed as a result of this research;

however, both of these orthoses had been designed with idiopathic

scoliosis in mind. Little research has been done into the effects of

bracing on the neuropathic curve. The use of dynamic Lycra garments in

the treatment of neurological scoliosis offers the advantage of deformity

correction without the bulk and discomfort of rigid braces. Recent clinical

experience has shown that the Lycra suits have a positive effect in the

treatment of scoliosis. The authors discussed the treatment of a child

presenting with a spinal tumor and although not truly of neurological

presentation indicates that the garment can be used for the different

scoliotic presentations.


In a phase 1 exploratory study, Matthews et al (2009) aimed to establish

proof of concept of the effects of dynamic elastomeric fabric orthoses (DEFOs) on the gait of children with spastic diplegic CP. Replicated

single case experiments employing an ABA methodology were carried out

on 8 subjects (median age of 5.5 years, range of 3 to 13 years; 4 girls and

4 boys) utilizing quantitative/qualitative data collection. Outcome

measures were: 10-meter walking test (10MWT); physiological cost index

(PCI); visual analog scale (VAS) scoring of perceived gait changes;

functional mobility changes using Patient Specific Functional Scale

(PSFS); subject/carer perceptions recorded in daily diaries. Results

identified following anal ysis of quantitative data indicated a treatment

effect from the orthoses, which could be corroborated by participant's

subjective impressions and comments. Statistically significant (p < 0.05)

intervention-related improvements in gait velocity and gait consistency

were identified in 5/8 and 4/8 subjects, respectively. Power calculations

support the feasibility of a larger controlled study to further investigate this

orthotic intervention. This study indicated that DEFO leggings can

confer beneficial effects on the gait of some children with spastic

diplegia resulting from CP. They noted that these findings have

implications for orthotic intervention w ith this subject group.

In a pilot study, Jeon et al (2012) evaluated the feasibility of intensive

training using a spring-assisted hand orthosis on upper extremity in

individuals with chronic hemiparetic stroke. A total of 5 participants for

the experimental group and 5 for the control group were recruited from a

local rehabilitation hospital. Subjects in the experimental group

participated in 4 weeks of training using a SaeboFlex orthosis for 1 hour

per day, 5 times per week. Each subject in the control group wore the

same orthosis for 1 hour per day without participating in upper extremity

training. Outcome measures included the Fugl-Meyer Assessment, Box

and Block Test, and Action Research Arm Test; kinematic parameters

were collected using a 3-D motion analysis system. The Fugl-Meyer

assessment and the Box and Block Test score were increased

significantly in the experimental group after the intervention. The

resultant velocity of the wrist joint for the reach-to-grasp task decreased

significantly, and the resultant velocity of the shoulder joint while

performing a reach-to-grasp task at acromion height decreased

significantly in the experimental group. The authors concluded that

spring-assisted dynamic hand orthosis training is feasible in recovering

the movement of the hemiparetic upper extremity.


In a pilot study, Barry et al (2012) compared the effect of therapy using a

wrist-hand orthosis (WHO) versus manual-assisted therapy (MAT)for

individuals with chronic, moderate-to-severe hemiparesis. The

relationship between the repetitions during therapy and functional change

was also examined. A total of 19 participants were randomly assigned to

either the WHO group (n = 10) or the MAT group (n = 9). The WHO

group performed therapy while wearing a dynamic WHO (SaeboFlex), the

MAT group performed therapy with manual assistance of a therapist.

Both groups participated in 1 hour of therapy per week for 6 weeks and

were prescribed exercises to perform at home 4 days per week. Pre- and

post-training assessments included grip strength, the Action Research

Arm Test (ARAT), Box and Blocks (B&B) test, and Stroke Impact Scale

(SIS). There were no significant between-group differences for any of the

measures. Within-group differences showed that the WHO group had a

significant improvement in the ARAT score (mean = 2.2; p = 0.04). The

MAT group had a significant improvement on the percent recovery on the

SIS (mean = 9.3 %; p = 0.03) and approached a significant improvement

on the ARAT (mean = 1.4; p = 0.08). When analyzing all participants

together, the relationship between the number of exercise repetitions and

functional improvement was moderate for the ARAT and the B&B test (r =

0.55, p = 0.02, and r = 0.30, p = 0.10, respectively). The authors

concluded that small improvements in function and perception of recovery

were observed in both groups, with no definite advantage of the WHO.

van der Heide and colleagues (2015) stated that numerous dynamic arm

supports have been developed in recent decades to increase

independence in the performance of activities of daily living. Much effort

and money have been spent on their development and prescription, yet

insight into their effects and effectiveness is lacking. These investigators

performed a systematic review of evaluations of dynamic arm supports.

The 8 technical evaluations, 12 usability evaluations, and 27 outcome

studies together make 47 evaluations. Technical evaluations were often

used as input for new developments and directed at balancing quality,

forces and torques, and range of motion of prototypes. Usability studies

were mostly single-measure designs that had varying results as to

whether devices were usable for potential users. An increased ability to

perform activities of daily living and user satisfaction were reported in

outcome studies. However, the use of dynamic arm supports in the home

situation was reported to be low. Gaining insight into why devices are not

used when their developers believe them to be effective seems crucial for

every new dynamic arm support developed. The authors noted that the


methodological quality of the outcome studies was often low, so it is

important that this is improved in the future.

In a systematic review and meta-analysis, Martins and colleagues (2016)

evaluated the effectiveness of suit therapy on functioning in children and

adolescents with CP. These researchers performed a comprehensive

search of peer-reviewed articles on electronic databases, from their

inception to May 2014. Studies included were rated for methodological

quality using the Physiotherapy Evidence Database scale. Effects of suit

therapy on functioning were assessed using meta-analytic techniques.

From the 46 identified studies, 4 met the inclusion criteria and were

included in the meta-analysis. Small, pooled effect sizes were found for

gross motor function at post-treatment (g = 0.46, 95 % confidence

interval [CI]: 0.10 to 0.82) and follow-up (g = 0.47, 95 % CI: 0.03 to

0.90). The authors concluded that the small number of studies, the

variability between them, and the low sample sizes were limitations of

this review.

Findings suggested that to weigh and balance benefits against harms,

clinicians, patients, and families need better evidence to examine and

prove the effects of short intensive treatment such as suit therapy on

gross motor function in children and adolescents with CP. Therefore, the

authors stated that more research based on high-quality studies focusing

on functioning in all dimensions of the International Classification of

Functioning, Disability and Health perspective is needed to clarify the

impact of suit therapy.

Almeida and colleagues (2017) noted that therapeutic suits or clothing,

whether associated with intensive protocols or not, became popular in the

rehabilitation of children with CP. Studies have reported positive effects

of these suits on children's posture, balance, motor function and gait. A

summary of current literature may help guide therapeutic actions. These

researchers evaluate the available evidence on the effects of

interventions based on the use of therapeutic suits in the treatment of

impairments and functional limitations of children with CP; 3 independent

reviewers searched for experimental studies on Medline, SciELO,

BIREME, LILACS, PEDro and CENTRAL databases, between October

and December 2015 and updated in May 2016. The reviewers evaluated

the methodological quality of selected studies using the Checklist for

Measuring Quality. The Grading of Recommendations Assessment,

Development and Evaluation was used to synthesize the quality of

evidence and strength of recommendation. From the 13 studies, 2

evaluated the Full Body Suit, 2 tested the Dynamic Elastomeric Fabric


Orthose, 3 evaluated TheraTogs and 6 tested the TheraSuit/AdeliSuit

protocols. The quality of evidence for the Full Body Suit, the Dynamic

Elastomeric Fabric Orthose and the TheraSuit/AdeliSuit protocols was

very low for body structure and function outcomes, while the evidence for

TheraTogs was low quality. Regarding the activity outcomes, the Full

Body Suit and TheraSuit showed very low quality evidence while the

evidence for TheraSuit/AdeliSuit protocols were of low quality. The

authors concluded that enthusiasm with new therapeutic approaches that

argue modifications in the neuro-musculoskeletal impairments and

functional limitations of children with CP need to be guided by scientific

evaluation. They stated that the low quality of evidence suggested

caution in recommending the use of these therapeutic suits.

Goyal and colleagues (2020) stated that Xia-Gibbs syndrome (XGS) is a

recently discovered genetic disorder. It is characterized by global

developmental delay, intellectual impairment, hypotonia, and sleep

abnormalities. While the current literature emphasizes on the genotype

and phenotype of this rare condition, it does not provide any description

of the physiotherapy management of patients with XGS. These

researchers described the case of a 27-month old Indian male diagnosed

with XGS, who presented with difficulty in sitting without support. He had

dysmorphic facies, hypotonia, hyper-extensible joints, mild

kyphoscoliosis, and global developmental delay. His parents and an

elder female sibling were clinically asymptomatic. The physiotherapy

intervention was based on the principles of neurodevelopmental

treatment (NDT) and sensory integration (SI). The management included

facilitation of transitions, weight-bearing exercises, wheel-barrow walking,

joint compressions, rib cage mobilization, multi-directional reaching, and

pushing-pulling activities along with the use of equipment like Swiss ball,

balance board, stability disc, trampoline, swing system, walker (rollator),

and walking harness. Furthermore, SPIO for the trunk and ankle-foot

orthosis (AFO) followed by supra-malleolar orthosis (SMO) were used for

support. Thereafter, the child was able to stand and walk without support

at the age of 36 months; and walked on uneven terrain at the age of 42

months. In addition, he could negotiate stairs using handrails with mild

assistance. His gross motor function measure-88 (GMFM-88) total score

improved from 21 % at the presentation to 66.6 % following the treatment.

It was observed that the NDT and SI approaches along with the use of

appropriate orthoses accelerated the achievement of motor milestones in

this case. The authors concluded that to the best of their knowledge, this

was the 1st case report of a child with XGS that emphasized on the


course of physiotherapy management for the associated motor delay.

Moreover, these researchers stated that further studies to examine the

potential of physiotherapy in early intervention programs as well as during

the life span of patients with XGS are needed.

El-Bagalaty and Ismaeel (2021) noted that osteoporosis because of

physical inactivity is one of the major complications associated with

neuromuscular disorders. These researchers compared using Suit

therapy and whole-body vibration (WBV) in addition to selected physical

therapy (PT) program to improve bone mineral density (BMD) in children

with CP of spastic diplegia. A total of 46 patients were classified

randomly into 2 equal groups. Patients in group A engaged in a selected

PT program in addition to suit therapy training program; while those in the

group B received the same PT program as in group A in addition to the

WBV training program. The treatment programs were carried out 3

times/week for 12 successive weeks. Measurements obtained included

BMD at the lumbar spine as well as at the femoral neck; these measures

were recorded pre- and post-treatment. There was a significant

improvement in favor of the WBV group; BMD improved significantly at

both the lumbar spine (p = 0.038) and the femoral neck (p = 0.005) in the

WBV group as compared to the Suit therapy group. The aut hors

concluded that WBV was effective in improving BMD rather than Suit

therapy in children with CP of spastic diplegia. They noted that this study

was limited to one type of CP in addition to a limited range of age.

Moreover, these researchers stated that further future studies are

needed on different types of CP, larger sample, for a longer period, using

different age groups as well as using different assessment tools.

Dynamic Movement Orthoses

Serrao and colleagues (2017) noted that patients with cerebellar ataxia

show increased upper body movements, which have an impact on

balance and walking. In a longitudinal, uncontrolled study, these

researchers examined the effect of using dynamic movement orthoses

(DMO), designed as elastic suits, on trunk motion and gait parameters. A

total of 11 patients (7 men, 4 women; mean age of 49.9 ± 9.5 years) with

degenerative cerebellar ataxia were enrolled in this study. Linear over

ground gait of patients was recorded using an opto-electronic gait

analysis system before DMO use (DMO-) and during DMO use (DMO+).

Time-distance parameters, lower limb joint kinematics, body sway, trunk

oscillations, and gait variability (coefficient of variation, CV) were

recorded. Patient satisfaction with DMO device was measured using


Quebec user evaluation of satisfaction with assistive technology. When

using the DMO, patients showed a significant decrease in stance phase

duration, double support phase duration, swing phase CV, pelvic range of

movements (ROMs), body sway, and trunk ROMs. A significant increase

was observed in the swing phase duration and knee joint ROMs. Of the

11 subjects, 10 were either quite satisfied (8 points) or very satisfied (2

points) with the assistive device. The authors concluded that the DMO

reduced the upper body motion and improved balance-related gait

parameters. These researchers proposed that DMO be used as an

assistive/rehabilitative device in the neur o-rehabilitation of cerebellar

ataxia to improve the trunk control and ga it stability. They stated that

DMO may be considered a prototype that can be modified in terms of

material characteristics, textile layers, elastic components, and diagonal

and lateral seams. These preliminary findings need to be validated by

well-designed studies.

Robotic Suits

Awad and colleagues (2017) noted that stroke-induced hemi-paretic gait

is characteristically slow and metabolically expensive. Passive assistive

devices such as ankle-foot orthoses are often pr escribed to increase

function and independence after stroke; however, walking remains highly

impaired despite-and perhaps because of-their use. These researchers

examined if a s oft wearable robot (exosuit) designed to supplement the

paretic limb's residual ability to generate both forward propulsion and

ground clearance could facilitate more normal walking after stroke.

Exosuits transmit mechanical power generated by actuators to a wearer

through the interaction of garment-like, functional textile anc hors and

cable-based transmissions. They evaluated the immediate effects of an

exosuit actively assisting the paretic limb of individuals in the chronic

phase of stroke recovery during treadmill and over-ground walking. Using

controlled, treadmill-based biomechanical investigation, these

investigators demonstrated that exosuits could function in synchrony with

a wearer's paretic limb to facilitate an immediate 5.33 ± 0.91° increase in

the paretic ankle's swing phase dorsiflexion and 11 ± 3 % increase in the

paretic limb's generation of forward propulsion (p < 0.05). These

improvements in paretic limb function contributed to a 20 ± 4 % reduction

in forward propulsion inter-limb asymmetry and a 10 ± 3 % reduction in

the energy cost of walking, which was equivalent to a 32 ± 9 % reduction

in the metabolic burden associated with post-stroke walking. Relatively

low assistance (approximately 12 % of biological torques) delivered with a

light-weight and non-restrictive exosuit was sufficient to facilitate more


normal walking in ambulatory individuals after stroke. The authors

concluded that future work will focus on understanding how exosuit

induced improvements in walking performance may be leveraged to

improve mobility after stroke.

Watanabe and associates (2019) noted that spinal cord injury (SCI)

causes gait disturbance because of paresis, spasticity, and sensory

disturbance of the lower limbs. There is no effective medical treatment

for SCI, and conventional rehabilitation alone is the main approach to

helping individuals work toward independent walking. These researchers

evaluated the effect of gait treatment using the Hybrid Assistive Limb

(HAL) on acute SCI. A 61-year old woman and a 62-year old man with

incomplete paraplegia participated in this study. Study participants

received gait treatment with HAL 3 to 4 times per week, with a total of 7 to

8 sessions (20 mins), in addition to conventional physical therapy. The

American Spinal Injury Association Impairment Scale, Lower Extremity

Motor Score (LEMS), Modified Ashworth Scale (MAS), the Walking Index

for Spinal Cord Injury (WISCI II), comfortable gait speed (CGS), stride,

cadence, Barthel Index (BI), Functional Independence Measure (FIM),

modified Rankin Scale (mRS), joint angles, and adverse effects were

assessed prior to HAL treatment and post-HAL treatment. HAL facilitated

intensive gait treatment in people during the acute phase after SCI.

Improvements in LEMS, WISCI II, CGS, stride, cadence, BI, FIM, mRS,

and joint angles were observed in both study participants. Furthermore,

decreased spasticity in the gastrocnemius muscle was found in 1

participant as assessed by MAS. The authors concluded that gait

treatment using HAL may be beneficial for paraplegic, non-ambulatory

individuals with acute SCI; HAL may be useful for intensive gait treatment

without increasing spasticity.

Benik Vest/Trunk Support (Benik Dynamic Trunk Orthosis)

The Benik vest/trunk support (Benik dynamic trunk orthosis) is a 2-piece

dynamic body vest that is constructed of 3mm ventilated neoprene and is

terry-lined for comfort. Velcro straps on the front half of the vest adhere to

the Velcro-sensitive material of the vest back. Velcro straps at shoulders,

sides and crotch provide for maximum adjustment. The orthosis provides

upper trunk support and proprioceptive input. The vest will provide

warmth and added buoyancy during hydrotherapy and other water

activities, but is not to be used as a life preserver.


There is a lack of evidence regarding the effectiveness of the Benik

vest/trunk support (Benik dynamic trunk orthosis) for any indication.

CPT Codes/ HCPCS Codes/ICD-10 CodesInformation in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by “+”

Code Code Description

CPT codes not covered for indications listed in the CPB:

There is no specific code for suit therapy:

HCPCS codes not covered for indications listed in the CPB:

Suit therapy device, Dynamic Movement Orthoses, Benik vest/trunk support (Benik dynamic trunk orthosis) - no specific code:

L1200 Thoracic-lumbar-sacral-orthosis(tlso), inclusiveof

furnishing initial orthosis only

ICD-10 codes not covered for indications listed in the CPB (not all-inclusive):

F84.0 -

F84.9

Pervasive developmental disorders

G80.0 -

G80.9

Cerebral palsy

G81.00 -

G81.94

Hemiplegia and hemiparesis

I69.00 -

I69.998

Sequelae of cerebrovascular disease

M40.00 -

M41.9

Kyphosis and scoliosis

Code Code Description

M62.81 -

M62.89

Other specified disorders of muscle [low trunk tone]

The above policy is based on the following references:

1. Almeida KM, Fonseca ST, Figueiredo PRP, et al. Effects of

interventions with therapeutic suits (clothing) on impairments

and functional limitations of children with cerebral palsy: A

systematic review. Braz J Phys Ther. 2017;21(5):307-320.


2. Autti-Rämö I, Suoranta J, Anttila H, et al. Effectiveness of upper

and lower limb casting and orthoses in children with cerebral

palsy: An overview of review articles. Am J Phys Med Rehabil.

2006;85(1):89-103.

3. Awad LN, Bae J, O'Donnell K, et al. A soft robotic exosuit

improves walking in patients after stroke. Sci Transl Med.

2017;9(400).

4. Bailes AF, Greve K, Burch CK, et al. The effect of suit wear during an

intensive therapy program in children with cerebral palsy. Pediatr

Phys Ther. 2011;23(2):136-142.

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;22(1):76-85.

6. Bar-Haim S, Harries N, Belokopytov M, et al. Comparison of

efficacy of Adeli suit and neurodevelopmental treatments in

children with cerebral palsy. Dev Med Child Neurol.

2006;48(5):325-330.

7. Barry JG, Ross SA, Woehrle J. Therapy incorporating a dynamic

wrist-hand orthosis versus manual assistance in chronic stroke: A

pilot study. J Neurol Phys Ther. 2012;36(1):17-24.

8. Blair E, Ballantyne J, Horsman S, Chauvel P. A study of a dynamic

proximal stability splint in the management of children with

cerebral palsy. Dev Med Child Neurol. 1995;37(6):544-554.

9. Chauvel PJ, Horsman S, Ballantyne J, Blair E. Lycra splinting and

the management of cerebral palsy. Dev Med Child Neurol.

1993;35(5):456-457.

10. El-Bagalaty AE, Ismaeel MMI. Suit therapy versus whole-body

vibration on bone mineral density in children with spastic

diplegia. JMusculoskeletNeuronal Interact.2021;21(1):79-84.

11. Euromed Rehabilitation Center. Adeli Suit. Mielno, Poland:

Euromed; 2004. Available at:

http://www.euromed.pl/en/index.php. Accessed November 17,

2004.

12. Flanagan A, Krzak J, Peer M, et al. Evaluation of short-term

intensive orthotic garment use in children who have cerebral

palsy. Pediatr Phys Ther. 2009;21(2):201-204.

13. Free Motion Rehabilitation Center. History of the therasuit. Howell,

NJ: Free Motion Rehabilitation Center; February 15, 2003. Available

at: http://freemotionrehab.com/History%20Of%20TheraSuit.pdf.

Accessed November 18, 2004.

14. Goyal C, Naqvi W, Sahu A. Xia-Gibbs syndrome: A rare case

report of a male child and insight into physiotherapy

management. Cureus. 2020;12(8):e9622.

http://www.euromed.pl/en/index.php

http://freemotionrehab.com/History%20Of%20TheraSuit.pdf


15. Health Care Insurance Board/College vor zorgverzekerigen (CVZ).

Revalidatiezorg: Behandeling in het Adeli revalidatiecentrum in

Slowakije is geen te verzekeren prestatie. Diemen, The

Netherlands; CVZ; November 27, 2007.

16. Hylton N, Allen C. The development and use of SPIO Lycra

compression bracing in children with neuromotor deficits.

Pediatr Rehabil. 1997;1(2):109-116.

17. Iavorskii AB, Kobrin VI, Sologubov EG, et al. Changes in individual

profiles of cerebral hemispheric asymmetry during

somatosensory stimulation due to wearing of G-suits by healthy

adults and children. Aviakosm Ekolog Med. 1997;31(6):18-23.

18. Iavorskii AB, Sologubov EG, Kobrin VI, et al. The influence of space

loading suits on interhemispheric asymmetry of the brain in

infantile spastic cerebral palsy. Zh Nevrol Psikhiatr Im S

Korsakova. 1998;98(9):26-29.

19. Jeon HS, Woo YK, Yi CH, et al. Effect of intensive training with a

spring-assisted hand orthosis on movement smoothness in upper

extremity following stroke: A pilot clinical trial. Top Stroke Rehabil.

2012;19(4):320-328.

20. Liptak GS. Complementary and alternative therapies for cerebral

palsy. Ment Retard Dev Disabil Res Rev. 2005;11(2):156-163.

21. Maguire C, Sieben JM, Erzer F, 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 multi-centre, single blind, randomised

control trial. BMC Neurol. 2012;12:18.

22. Martins E, Cordovil R, Oliveira R, et al. Efficacy of suit therapy on

functioning in children and adolescents with cerebral palsy: A

systematic review and meta-analysis. Dev Med Child Neurol.

2016;58(4):348-360.

23. Matthews M, Crawford R. The use of dynamic Lycra orthosis in

the treatment of scoliosis: A case study. Prosthet Orthot Int.

2006;30(2):174-181.

24. Matthews MJ, Watson M, Richardson B. Effects of dynamic

elastomeric fabric orthoses on children with cerebral palsy.

Prosthet Orthot Int. 2009;33(4):339-347.

25. National Horizon Scanning Centre (NHSC). Lycra garments for

cerebral palsy and movement disorders -- horizon scanning

review. Birmingham, UK: NHSC; 2002.

26. Nemkova SA, Sologubov EG, Iavorskii AB. New possibilities of the

use of space technologies in the treatment of children with

injuries of the central nervous system. Aviakosm Ekolog Med.


2002;36(3):55-58.

27. NHS Quality Improvement Scotland (NHS QIS). Evidence note 11:

Dynamic lycra splinting for children with cerebral palsy. Glasgow,

Scotland: NHS QIS; December 2005.

28. Nicholson JH, Morton RE, Attfield S, Rennie D. Assessment of

upper-limb function and movement in children with cerebral

palsy wearing lycra garments. Dev Med Child Neurol.

2001;43(6):384-391.

29. No authors listed. Theratogs. Pediatr Phys Ther. 2003;15(2):142-

143.

30. North Oakland Medical Centers (NOMC), Euro-Peds Program.

SUIT Therapy. Pontiac, MI: Euro-Peds; 2004. Available at:

http://www.europeds.org/epp_st.htm. Accessed November 17,

2004.

31. Rennie DJ, Attfield SF, Morton RE, et al. An evaluation of lycra

garments in the lower limb using 3-D gait analysis and functional

assessment (PEDI). Gait Posture. 2000;12(1):1-6.

32. Rosenbaum P. Controversial treatment of spasticity: Exploring

alternative therapies for motor function in children with cerebral

palsy. J Child Neurol. 2003;18 Suppl 1:S89-94.

33. Semenova KA, Antonova LV. The influence of the LK-92 'Adeli'

treatment loading suit on electro-neuro-myographic

characteristics in patients with infantile cerebral paralysis. Zh

Nevrol Psikhiatr Im S Korsakova.1998;98(9):22-25.

34. Semenova KA. Basis for a method of dynamic proprioceptive

correction in the restorative treatment of patients with residual-

stage infantile cerebral palsy. Neurosci Behav Physiol.

1997;27(6):639-643.

35. Semenova KA. The validation of a method of dynamic

proprioceptive correction for the rehabilitative treatment of

patients with the residual stage of infantile cerebral palsy. Zh

Nevropatol Psikhiatr Im S S Korsakova. 1996;96(3):47-50.

36. Serrao M, Casali C, Ranavolo A, et al. Use of dynamic movement

orthoses to improve gait stability and trunk control in ataxic

patients. Eur J Phys Rehabil Med.2017;53(5):735-743.

37. Shvarkov SB, Davydov OS, Kuuz RA, et al. New approaches to the

rehabilitation of patients with neurological movement defects.

Neurosci Behav Physiol. 1997;27(6):644-647.

38. Shvarkov SB, Davydov OS, Kuuz RA, et al. New approaches to the

rehabilitation of patients with neurological motor defects. Zh

Nevropatol Psikhiatr Im S S Korsakova. 1996;96(3):51-54.

39. Sologubov EG, Iavorskii AB, Kobrin VI, et al. Role of vestibular and

visual analyzers in changes of postural activity of patients with

http://www.europeds.org/epp_st.htm


childhood cerebral palsy in the process of treatment with space

technology. Aviakosm Ekolog Med. 1995;29(5):30-34.

40. Sologubov EG, Iavorskii AB, Kobrin VI. The significance of visual

analyzer in controlling the standing posture in individuals with the

spastic form of child cerebral paralysis while wearing 'Adeli' suit.

Aviakosm Ekolog Med. 1996;30(6):8-13.

41. Therasuit LLC. Intensive Suit Therapy for Cerebral Palsy. Keego

Harbor, MI: Cerebral Palsy Pediatric Fitness Center; 2004. Available

at: http://www.suittherapy.com/. Accessed December 2, 2004.

42. United Cerebral Palsy (UCP) Research & Education Foundation.

New: The Adeli Suit Update, 11/2004. Research Fact Sheets.

Washington, DC: UCP; November 2004. Available at:

http://www.ucp.org/ucp_generaldoc.cfm/1/4/24/24-24/5896.

Accessed December 1, 2004.

43. United Cerebral Palsy (UCP) Research & Education Foundation.

The Adeli Suit, 3/99. Research Fact Sheets: Diagnosis/Treatment.

Washington, DC: UCP; March 1999. Available at:

http://www.ucp.org/ucp_generaldoc.cfm/1/4/24/24-6608/82.

Accessed November 17, 2004.

44. van der Heide LA, Gelderblom GJ, de Witte LP. Effects and

effectiveness of dynamic arm supports: A technical review. Am J

Phys Med Rehabil. 2015;94(1):44-62.

45. Watanabe H, Marushima A, Kawamoto H, et al. Intensive gait

treatment using a robot suit hybrid assistive limb in acute spinal

cord infarction: Report of two cases. J Spinal Cord Med.

2019;42(3):395-401.

http://www.suittherapy.com/

http://www.ucp.org/ucp_generaldoc.cfm/1/4/24/24-24/5896

http://www.ucp.org/ucp_generaldoc.cfm/1/4/24/24-6608/82


Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and

constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or

program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any

results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna

or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be

updated and therefore is subject to change.

Copyright © 2001-2021 Aetna Inc.


AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical Policy Bulletin Number: 0696 Suit Therapy

There are no amendments for Medicaid.

updated 09/24/2021

Documents

0696 Suit Therapy Medical Clinical Policy Bulletins