0696 suit therapy medical clinical policy bulletins
TRANSCRIPT
Suit Therapy - Medical Clinical Policy Bulletins | Aetna Page 1 of 21
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).
Suit Therapy - Medical Clinical Policy Bulletins | Aetna Page 2 of 21
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
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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.
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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.
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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.
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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
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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.
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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.
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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
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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
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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
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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
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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
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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.
Suit Therapy - Medical Clinical Policy Bulletins | Aetna Page 15 of 21
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.
Suit Therapy - Medical Clinical Policy Bulletins | Aetna Page 16 of 21
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.
Suit Therapy - Medical Clinical Policy Bulletins | Aetna Page 17 of 21
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.
Suit Therapy - Medical Clinical Policy Bulletins | Aetna Page 18 of 21
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
Suit Therapy - Medical Clinical Policy Bulletins | Aetna Page 19 of 21
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.
Suit Therapy - Medical Clinical Policy Bulletins | Aetna Page 20 of 21
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.
Suit Therapy - Medical Clinical Policy Bulletins | Aetna Page 21 of 21
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