R E S E A R C H A R T I C L E

The Effect of Suit Wear During an

Intensive Therapy Program in
Children With Cerebral Palsy
Amy F. Bailes, PT, MS, PCS; Kelly Greve, MPT, PCS; Carol K. Burch, PT, MEd, DPT; Rebecca Reder, OTD, OTR/L; Li Lin, MS;
Myra M. Huth, PhD, RN, FAAN
The Division of Occupational Therapy and Physical Therapy (Mss Bailes and Greve and Drs Burch and Reder) and The
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Center for Professional Excellence, Research, and Evidence Based Practice (Ms Lin and Dr Huth), Cincinnati Children’s
Hospital Medical Center, Cincinnati, Ohio.

Purpose: To examine the effects of suit wear during an intensive therapy program on motor function among
children with cerebral palsy. Method: Twenty children were randomized to an experimental (TheraSuit) or
a control (control suit) group and participated in an intensive therapy program. The Pediatric Evaluation
of Disability Inventory (PEDI) and Gross Motor Function Measure (GMFM)–66 were administered before and
after (4 and 9 weeks). Parent satisfaction was also assessed. Results: 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. Conclusions: 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. (Pediatr Phys Ther 2011;23:136–142) Key words:
ADL, cerebral palsy, cerebral palsy/classification, cerebral palsy/rehabilitation, child, child/preschool, clothing,
patient satisfaction, physical therapy/modalities, movement, psychomotor performance, randomized control
trial, treatment outcome

INTRODUCTION in meaningful activities. In addition, PTs may recommend

Cerebral palsy (CP) is the most common neurologic
condition seen by pediatric physical therapists (PTs)1 with
recent studies reporting a prevalence rate of 3.6 per 1000.2
Physical therapy intervention for children with CP may
include strengthening and task-specific training with the
goal of helping them reach their full potential to participate
0898-5669/110/2302-0136
Pediatric Physical Therapy
Copyright C 2011 Wolters Kluwer Health | Lippincott Williams &
Wilkins and the Section on Pediatrics of the American Physical
Therapy Association
Correspondence: Amy F. Bailes, PT, MS, PCS, Division of Occupa-
tional Therapy and Physical Therapy, Cincinnati Children’s Hospital
Medical Center, 3333 Burnet Ave, MLC 4007, Cincinnati, OH 45229
(amy.bailes@cchmc.org).
Grant Support: This study was supported by the Cincinnati
Children’s Hospital Medical Center (CCHMC) Research Foundation and
the CCHMC Patient Care Innovations Fund. A Foundation for Physical
Therapy Promotion of Doctoral Studies (PODS I) scholarship 2009-2010
was also awarded to Ms Bailes.
DOI: 10.1097/PEP.0b013e318218ef58
that children wear orthotic garments to control abnormal
tone, stabilize posture, and improve function. Investiga-
tors evaluating the effects of orthotic garments in children
with CP have reported increased confidence for attempting
motor tasks,3,4 improved postural stability,3,5,6 improved
gait kinematics,4 and some functional improvements.3,5,6
However, all of these investigators reported adverse effects
from wearing the orthotic garments such as decreased res-
piratory function,3 heat and skin discomfort,4-6 and toilet-
ing difficulties.5,6 In addition, the majority of parents chose
not to continue garment wear.5,6 In previous studies, the
intervention consisted of wearing the orthotic garments 4
to 12 hours a day3-7 during typical daily schedules.
Recently, other types of orthotic garments or “suits”
have been marketed (eg, TheraSuit, Adeli) that are to be
worn, while participating in an intensive therapy program
rather than during typical daily schedules. These suits
incorporate bungee cords to provide resistance, and the
makers claim the suit accelerates progress. One study re-
ported the effects of an intensive suit therapy program on
a sample of heterogeneous children with CP and found no

136 Bailes et al Pediatric Physical Therapy

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Association. Unauthorized reproduction of this article is prohibited.
 difference between the intensive suit therapy group and
children who received a neurodevelopmental approach
with a similar intensity.8 A recent case report of 2 children
with CP demonstrated minimal changes in motor function
after an intensive suit therapy program with some positive
changes measured with gait analysis.9 None of the investi-
gators reported the effects of the suit itself.
Although evidence supporting intensive suit therapy
is limited, families continue to seek these treatment pro-
grams for their children with the expectation of acceler-
ating gross motor development even though they require
significant resources. Aside from the intensity of the pro-
grams, several hours a day up to 5 days a week, the suits are
expensive, time-consuming to don and doff, and uncom-
fortable. Damiano10 suggests “dissecting” programs such
as suit therapy to examine the different components. In
addition, Turner11 recommends a clinical trial in which
both groups receive the same intervention except for the
suit to determine its effectiveness. Further study is needed
to determine whether using a suit is justified.
Therefore, the purpose of this randomized, con-
trolled, single-blinded study was to determine the effect
of wearing a suit during an intensive therapy program on
motor function among children with CP, specifically to
evaluate (a) the improvement of motor function, (b) to
what extent the suit (TheraSuit) affects improvement in
motor function, and (c) parent satisfaction with the in-
tensive therapy program. This study was undertaken in
response to multiple families who requested that a suit
therapy program be offered at the authors’ institution, in
addition to therapists wanting evidence to understand this
intervention. This study is the first to evaluate the effects of
this suit on a group of similarly functioning children with
CP, includes a control group receiving the same therapy
with the exception of the suit, and uses assessors who are
blind to group assignment.
METHODS
Eligibility Requirements
Children were eligible to participate if they were
between 3 and 8 years of age, had a diagnosis of CP, were
classified as level III on the Gross Motor Functional Clas-
sification System (GMFCS),12 and had not previously par-
ticipated in an intensive suit therapy program. In addition,
the children had to be able to follow instructions and show
no evidence of hip subluxation greater than 35% (migra-
tion index) and/or scoliosis greater than 25◦ (Cobb angle)
on hip and spine x-rays, respectively, within 6 months
of the start of intervention. The parent/guardian needed
to speak and read English, and physician approval was
obtained for each child to participate. Exclusion criteria
were intrathecal baclofen pump therapy, history of selec-
tive dorsal rhizotomy, or Botox injections within the last
3 months, orthopedic surgery within the past year, serial
casting within the past month, uncontrolled seizures, and a
diagnosis of autism, attention-deficit disorder, other mus-
Pediatric Physical Therapy
Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins and the Section on Pediatrics of the American Physical Therapy
Association. Unauthorized reproduction of this article is prohibited.
culoskeletal diseases, progressive encephalopathies, and/or
psychiatric or behavioral disorders.
Recruitment
Twenty children with CP aged 3 to 8 years were re-
cruited between August 2005 and August 2007. Methods
for recruitment included letters to parents of children di-
agnosed with CP receiving intervention at this institution,
flyers to local parent support groups, and postings to rele-
vant Web sites and magazines that parents of children with
CP could access. All children who were recruited partic-
ipated in the intervention at a 523-bed highly specialized
quaternary care pediatric hospital and research center in
the Midwest. This study was approved by the hospital’s in-
stitutional review board and a parent of each participating
child provided consent.
Randomization
Participants were randomized to the experimental
or control group by a computerized minimization pro-
gram (Minimization software, Michael Conlon, Division of
Biostatistics, Department of Statistics, University of
Florida, Gainesville, May 1991). The minimization proce-
dure controlled for potentially confounding variables, such
as the patient’s age, gender, and race. Age was categorized
into 2 groups—3 years to less than 5 years, and 5 years
and more. Therefore, systematic selection bias and chance
skewing were reduced, and the 2 groups were comparable
with minimized error variance of the covariates. See Figure
1 for study enrollment flow.
Outcome Measures
Pediatric Evaluation of Disability Inventory. The Pe-
diatric Evaluation of Disability Inventory (PEDI) is a 197-
item parental-report questionnaire that measures func-
tional skills (FS) and caregiver assistance (CA) across the
domains of self-care, mobility, and social functioning of
infants and children aged 6 months to 71/2 years. However,
the PEDI can be used with older children if their abili-
ties are less than expected for a 71/2-year-old child without
disabilities.13 In this study, the Self-care and Mobility do-
mains within each scale were used, as it was expected that
the intervention might change scores in these areas. For
the FS scale, each item on the PEDI is scored as 0 (unable
to perform) or 1 (able to perform), and a total score is ob-
tained by adding the items.13 For the CA scale, the items
are scored from 0 to 5 (0 = total assistance to 5 = com-
pletely independent). Internal consistency coefficients for
the scales of the PEDI range from 0.95 to 0.99.13 Concur-
rent and construct validity of the PEDI has been reported.14
In addition, the PEDI is responsive to change in motor
function of children with CP.15 The PEDI was scored ac-
cording to test manual instructions and scaled scores were
used in the analyses. In the current study, correlation co-
efficients for the PEDI over the 3 assessment times were
0.86 to 0.96, thus demonstrating good reliability.
Effect of Suit Wear in Children With CP 137

Fig. 1. Diagram of the flow of participants through each stage
of the randomized trial.
Gross Motor Function Measure–66. The Gross Mo-
tor Function Measure–66 (GMFM-66) is a valid and reli-
able (ICC, 0.99)16 clinical evaluation tool that measures
change in motor skills in children with CP.17 It consists
of 66 items organized into 5 dimensions: (1) lying and
rolling; (2) sitting; (3) crawling and kneeling; (4) stand-
ing; and (5) walking, running, and jumping. Item scores
range from 0 to 3 (0 = does not initiate to 3 = completes).
GMFM-66 total scores were calculated using the Gross
Motor Ability Estimator computer program provided by
the test developers, which converts item scores into a total
interval level score. The GMFM-66 is sensitive to change
in motor performance of children with CP over time18 and
is commonly used in studies to evaluate effects of inter-
vention in children with CP.19-22 In this study, correlation
coefficients for the GMFM-66 over the 3 assessment times
were 0.92 to 0.97, thus demonstrating good reliability.
Parent Satisfaction
Parent satisfaction was assessed by a nonstandardized
investigator-developed questionnaire that was given to the
parent at the last appointment. Frequencies were calcu-
lated and reported for parent responses to the following
questions: (1) rate your child’s level of comfort during the
program (no discomfort, very minimal, mild, moderate,
severe); (2) do you think wearing the garment helped
your child? (yes, no, unsure); and (3) would you enroll
your child in the intensive therapy program again? (yes,
no, unsure).
138 Bailes et al
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Association. Unauthorized reproduction of this article is prohibited.
Procedure
All participants were assessed without the suit on, at
baseline (3–10 days before the intervention), at 4 weeks
(3–10 days after the intervention), and at 9 weeks (1 month
after the intervention). During each assessment, the chil-
dren were weighed and the GMFM-66 and the PEDI Self-
care and Mobility domains were administered. Weight was
measured at each time point using the same scale, because
parents expressed concerns that the children might lose
weight because of the program’s intensity. Assessments
were completed by 1 of the 2 PTs with 12 and 16 years of
pediatric experience. The assessing therapists were blinded
to group assignment and each child was assessed by the
same therapist at all times. Parents and therapists were in-
structed regarding the importance of not discussing their
thoughts on which group they believed the child was as-
signed. The therapists were trained and had used the mea-
surement tools in the clinic prior to the study. In addition,
procedures were reviewed prior to data collection and in-
terrater agreement was established (ICCs: 0.97 GMFM-66,
0.99 PEDI) against a trained therapist (the first author).
Intervention
Both groups received the therapy intervention for 4
hours daily, 5 days a week over a 3-week period. Physical
therapists and occupational therapists employed by this
institution provided intervention to both groups and were
trained in the TheraSuit Method.9 Both groups followed
the previously described activity sequence and description
of the TheraSuit Method. During the intervention, the ex-
perimental group wore the TheraSuit with elastic bungee
cords attached to the vest, shorts, kneepads, and shoes,
as described in the training manual.23 The control group
wore a “control suit,” which consisted of only the Thera-
Suit vest and shorts and did not have the elastic bungee
cords attached. It was felt that the vest and shorts, which
are made of canvas, did not provide added benefit when
worn without the bungee cords and therefore could be
the control. Each child’s intervention was individualized
to the goal of achieving the next functional activity level.
Therapists maintained a daily log of all activities/exercises
completed, behavior, rest breaks, and any adverse safety
events. At the end of the 3-week intervention, each child
was given an individualized home exercise program to per-
form not more than 1 hour daily from weeks 4 through 9.
The participants did not receive any other direct occupa-
tional therapy or physical therapy services for the duration
of the study protocol. Parent satisfaction with the program
was assessed at the last assessment via a nonstandardized
questionnaire.
Statistical Analysis
Descriptive statistics were used to summarize the sam-
ple demographics and outcome variables. Student t tests
and exact tests were used to compare demographic and
baseline measurements of the experimental and control
Pediatric Physical Therapy
 groups. Linear mixed models for repeated measures were
conducted to (1) check differences in mean GMFM-66 and
PEDI scores over time within and between groups; (2) cal-
culate effect sizes between groups for GMFM-66 and PEDI
outcomes; and (3) evaluate the change in weight for each
group over the 9 weeks. Also, intention-to-treat analysis
was considered. Tukey pairwise adjustments were used
for all significant variables. Effect sizes were interpreted as
follows: small, 0.20 to 0.50; moderate, 0.50 to 0.80; and
large, greater than 0.80.24 Power estimates were not per-
formed prior to data collection because it was not known
how much change to expect with this intervention. There-
fore, from this study, one could calculate effect sizes for
the outcome measures and inform future studies. All the
analyses were conducted using Statistical Analysis System
(SAS 9.1). A 2-sided significance level was set for α < 0.05.
RESULTS
Demographic and baseline characteristics of the sam-
ple are presented in Table 1. No significant differences were
found between groups at baseline with regard to age, gen-
der, race, weight, and initial GMFM-66 and PEDI scores.
Mean GMFM-66 and PEDI scores for both groups are pre-
sented in Table 2 across the 3 time points. All scores were
observed to improve across time.
Between Groups
Between-group P values and effect sizes were calcu-
lated and are presented in Table 3. After controlling for age,
gender, race, and baseline scores, no statistical significant
differences were found between groups on the GMFM-66
or any domains of the PEDI. A small negative effect size
was found for the PEDI CA Mobility domain. All other
effect sizes were small and positive.
Within Groups
Results of the linear mixed modes for repeated mea-
sures within each group showed a significant difference
for the control group on the GMFM-66 at week 9 versus
baseline (see Table 4). The experimental group demon-
strated significant differences for 4 of the outcome mea-
sures, GMFM-66, PEDI FS self-care, PEDI CA self-care,
and PEDI FS mobility.
Weight
Mean weight for the experimental group was 17.27
kg (SD = 4.53) at baseline, 17.54 kg (SD = 4.76) at week
4, and 17.93 kg (SD = 4.91) at week 9. For the control
group, mean weight was 17.19 kg (SD = 4.59) at baseline,
17.49 kg (SD = 4.68) at week 4, and 18.23 kg (SD = 4.76)
at week 9. Weight significantly increased across all time
points for both the control group and the experimental
group, F3,16 = 47.31 and F3,16 = 49.43, P < .0001.
Adverse Events
One child in the control group was not able to com-
plete the intervention and withdrew at day 12 because of
combative behaviors that posed a safety risk. However, the
child attended both follow-up assessments and the data
were used in the analysis.
No serious safety events were encountered or oc-
curred during the study such as fractures, hip dislocations,
or skin abrasions.
Satisfaction
Nineteen questionnaires were returned at the end of
the study. Ten of these were from parents whose child was
in the experimental group and 9 were from the control
group. All parents reported that their children experienced

TABLE 1
Demographic Characteristics and Baseline Measurements

Total Treatment Control

(N = 20) (n = 10) (n = 10) P

Age, M (SD) 4.9 (1.4) 4.8 (1.6) 5.0 (1.3) .7165a

Gender, n (%) .4737b
Male 9 (45) 4 (40) 5 (50)
Female 11 (55) 6 (60) 5 (50)
Race, n (%) 1.0000b
Black 1 (5) 0 (0) 1 (10)
Hispanic 1 (5) 0 (0) 1 (10)
White 18 (90) 10 (100) 8 (80)
Weight, M (SD) 17.2 (4.4) 17.3 (4.5) 17.2 (4.6) .9691a
GMFM-66, M (SD) 49.64 (5.71) 47.93 (5.33) 51.34 (5.83) .1883a
PEDI, M (SD)
FS self-care 56.50 (10.13) 54.46 (10.60) 58.54 (9.75) .3823a
FS mobility 54.70 (10.21) 50.65 (11.92) 58.75 (6.47) .0751a
CA self-care 47.62 (12.16) 46.72 (13.27) 48.51 (11.59) .7517a
CA mobility 54.84 (15.43) 52.48 (20.26) 57.19 (8.92) .5096a

Abbreviations: CA, Caregiver Assistance Scale; FS, Functional Skills Scale; GMFM, Gross
Motor Function Measure; PEDI, Pediatric Evaluation of Disability Inventory.
a t test.
b Exact test.

Pediatric Physical Therapy Effect of Suit Wear in Children With CP 139

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 TABLE 2
Results for GMFM-66 and PEDI Scores (Scaled Score) for Experimental and
Control Groups

Outcome Baseline, M (SD) 4 weeks, M (SD) 9 weeks, M (SD)

GMFM-66
Experimental 47.93 (5.33) 49.10 (5.87) 50.08 (6.19)
Control 51.34 (5.83) 52.61 (7.24) 54.37 (5.21)
PEDI FS mobility
Experimental 50.65 (11.92) 51.50 (11.19) 53.91 (13.86)
Control 58.75 (6.47) 59.45 (9.07) 62.08 (8.48)
PEDI FS self-care
Experimental 54.46 (10.60) 55.69 (12.92) 56.67 (10.89)
Control 58.54 (9.75) 56.86 (7.03) 58.56 (7.00)
PEDI CA mobility
Experimental 52.48 (20.26) 51.20 (17.37) 53.91 (20.33)
Control 57.19 (8.92) 59.69 (12.37) 62.56 (8.64)
PEDI CA self-care
Experimental 46.72 (13.27) 49.32 (13.73) 49.91 (12.97)
Control 48.51 (11.59) 48.50 (10.76) 51.39 (10.64)

Abbreviations: CA, Caregiver Assistance Scale; FS, Functional Skills Scale; GMFM, Gross
Motor Function Measure; PEDI, Pediatric Evaluation of Disability Inventory.

TABLE 3
Effect sizes, P Values, and Confidence Intervals for Differences on GMFM-66 and PEDI
Outcomes Between the 2 Groups From Linear Mixed Models for Repeated Measures

Outcome Effect Size (Cohen’s d) P 95% Confidence Interval

GMFM-66 0.19 .4810 −3.35, 1.66

PEDI FS self-care 0.23 .4016 −7.45, 3.17
PEDI CA self-care 0.17 .5362 −5.34, 2.90
PEDI FS mobility 0.19 .4880 −6.43, 3.22
PEDI CA mobility −0.37 .1846 −1.90, 8.96

Abbreviations: CA, Caregiver Assistance Scale; FS, Functional Skills Scale; GMFM, Gross
Motor Function Measure; PEDI, Pediatric Evaluation of Disability Inventory.

TABLE 4
Within-Group Differences P Values (95% Confidence Intervals) of the Significant Outcomes Over Time

GMFM-66 PEDI FS Self-care PEDI CA Self-care PEDI FS Mobility PEDI CA Mobility

Control group
4th week vs baseline a a a a a

9th week vs baseline P = .0364 (0.12-3.24) a a a a

9th week vs 4th week a a a a a

Experimental group
4th week vs baseline a a P = .0419 (0.11-5.09) a a

9th week vs baseline P = .0026 (0.86-3.43) P = .0436 (0.07-4.35) P = .0152 (0.70-5.68) P = .0058 (1.08-5.44) a

9th week vs 4th week a a a P = .0324 (0.23-4.59) a

Abbreviations: CA, Caregiver Assistance Scale; FS, Functional Skills Scale; GMFM, Gross Motor Function Measure; PEDI, Pediatric Evaluation of
Disability Inventory.
a Not significant.

some level of discomfort during the program. For example,
7 parents (4 control and 3 experimental) reported minimal
discomfort, 7 parents (3 control and 4 experimental) re-
ported mild discomfort, 3 parents (experimental) reported
moderate discomfort, and 2 parents (control) reported se-
vere discomfort. When parents were asked whether they
thought wearing the suit helped their children, 4 parents
in the control group said no and 5 parents in the control
group were unsure. In contrast, 3 in the treatment group
were unsure and 7 in treatment group answered yes. Also,
17 parents reported that they would enroll their children
in the program again and 2 were unsure (1 in the control
group and 1 in the treatment group). The 2 parents who
were unsure also commented that the program was too
intense.
DISCUSSION
The results from this study demonstrate that children
with CP who wore the TheraSuit with attached bungee
cords during an intensive therapy program did not in-
crease function more than children who wore a control

140 Bailes et al Pediatric Physical Therapy

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Association. Unauthorized reproduction of this article is prohibited.
 suit (TheraSuit vest and shorts) during the same intensive
therapy program. This was the first study to examine the
different components of suit therapy and study the effects
of the suit itself. Strengths of this study include the fol-
lowing: subjects were randomized to an experimental or
control group; all children were of similar functional level
(GMFCS III); the age range of the children was narrow;
and the assessors were blinded to group assignment.
The effect sizes obtained in this study were positive
and in the small range with the exception of a negative
small effect size for PEDI CA mobility. The negative effect
size for PEDI CA mobility suggests that the control group
did better than the experimental group after intervention
on the CA scale. This is may be due to the greater variation
in the experimental group scores on the PEDI CA Mo-
bility domain, which has been reported elsewhere in the
literature.6 An alternative explanation would be that the
difference is real, and that the experimental group needed
more assistance with mobility skills following the inter-
vention.
Significant within-group differences were found in
this study, which is similar to a recent randomized clinical
trial of a cycling intervention in children with CP,25 where
no significant between-group differences were found but
significant differences were found within the experimen-
tal group. Intrasubject variability, even within the same
GMFCS level, may make it difficult to detect between-
group statistical significance. Therefore, future studies may
choose multiple baseline sessions as a part of studies to
evaluate interventions in children with CP.
Comparison among our findings and other studies is
difficult because no other studies have investigated the ef-
fects of the TheraSuit alone. Our findings are similar to
those reported by Bar-Haim,8 who compared a similar in-
tensive program with a similar suit to neurodevelopmental
treatment in children with CP. Both groups in the Bar-
Haim study showed significant changes in the GMFM-66
1 month following the intervention. Like the Bar-Haim
study, our study suggests that intensity is a principal fac-
tor in improvement. Bar-Haim examined the children again
at 10 months when the changes were not maintained.
Our study followed the children for only 1 month and
the children continued to show improvement. Longer-
term follow-up is needed to determine whether chil-
dren’s motor skills are maintained over time following this
intervention.
Comparison between our findings and previous stud-
ies of orthotic garments is also difficult for several rea-
sons. The previous studies4-7 used a variety of garment
types, garments were often worn at home for longer peri-
ods of time during each day with or without intervention
being performed, and postassessments were performed
with the garment on after achieving several hours of wear
time. Some previous investigators reported improvements
in GMFM scores,7 stability,6 and PEDI scores,5 whereas
others3,4 with postassessments that included both wearing
and not wearing the garment reported some improvements
in both conditions using varied outcome measures. The
Pediatric Physical Therapy
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procedure of the TheraSuit Method includes suit wear dur-
ing the therapy intervention and not necessarily at other
times during the day. In addition, postassessments in this
study were completed with the suit off. We did not find any
differences in GMFM-66 or PEDI scores between groups,
suggesting that the suit itself did not contribute to the gains
made.
Results of this study are similar to those of studies of
other garments that reported general discomfort and dif-
ficulty with wear.5-7 However, in the current study, most
parents in both the experimental and control groups re-
ported that their children had some level of discomfort
during the program. This finding suggests that at least
some of their discomfort might be due to the 4-hour length
of each session and 5-day-a-week frequency, as opposed to
suit wear.
Limitations
This study has several limitations related to the small
sample size and lack of blinding of families and treating
therapists. Strict enrollment criteria to ensure a homoge-
nous group also limited our sample size. Although we
did not tell the families which suit was the experimen-
tal suit, families verbalized knowledge of the TheraSuit
and/or TheraSuit Method or sought information outside of
the study; therefore, we were not able to assume that par-
ents were blinded to group assignment. This most likely
biased our PEDI results since PEDI is a parent report. In
addition, the parent satisfaction survey was not validated
and may not have been comprehensive enough to deter-
mine the benefits perceived by the families.
The GMFM-66 and PEDI are functional measures and
may not detect changes in gait, quality of movement, or en-
ergy efficiency, which may be important areas to consider.
In a recent case study, 2 children who participated in the
TheraSuit Method showed improvements in gait.9 The out-
come measures used for this study also did not account for
changes in assistive devices. For example, as reported by a
treating therapist, one child transitioned from a walker to a
single tripod cane and one child transitioned from a walker
to forearm crutches. Although the experimental group was
not shown to produce greater functional benefits than
the control group, therapists reported that they preferred
using the suit because it gave them more “hands” to achieve
better alignment during activities.
This study could have been strengthened if a control
group of children that did not participate in any therapy
were included in the comparisons. Finally, results from
this study cannot be generalized to children with CP of
other ages, other GMFCS levels, and/or in combination
with other interventions such as Botox or casting.
CONCLUSIONS
This study does not provide statistical evidence that
the use of the TheraSuit improves motor function dur-
ing intensive therapy programs more than an intensive
Effect of Suit Wear in Children With CP 141
 therapy program wearing a control suit for children with
CP classified as GMFCS level III. Future studies may
examine postural changes and gait efficiency with and
without suit wear in children with CP of varying func-
tional abilities. Single-subject studies with multiple as-
sessments may be able to detect changes that this study
could not. Until further studies are completed, thera-
pists should use this information to guide families who
are considering participating in intensive suit therapy
programs.
ACKNOWLEDGMENTS
The authors thank the following for their contri-
butions: families and children who graciously agreed to
participate in this study; intervention therapists Shannon
Brausch, PT, Michelle Menner, MPT, Shannon Teeters,
OTR/L, Russell Garrision, OTR/L, and Emily Owens
OTR/L; blinded assessors Cathy Lowe, PT, and Terri
Dinkelaker, PT; administrative support at intervention site:
Michelle Kiger, OTR/L; soft knee splints for participants
fabricated by the CCHMC Sewing Room; equipment pur-
chased by the Smiles for Kids Foundation; and 2 TheraSuits
donated by TheraSuit LLC.
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