Almeida 2017

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1 Brazilian Journal of Physical Therapy 2017;xxx(xx):xxx---xxx
2
3 Brazilian Journal of
Physical Therapy
https://www.journals.elsevier.com/brazilian-journal-of-physical-therapy
SYSTEMATIC REVIEW
4 Effects of interventions with therapeutic suits

5 (clothing) on impairments and functional limitations of
6 children with cerebral palsy: a systematic review
7 Q1 Kênnea M. Almeida a , Sérgio T. Fonseca b , Priscilla R.P. Figueiredo c , Amanda A. Aquino d ,
8 Marisa C. Mancini b,∗
a
9 Departamento de Educação Integrada em Saúde, Universidade Federal do Espírito Santo, Vitória, ES, Brazil
b
10 Programa de Pós-Graduação em Ciências da Reabilitação, Escola de Educação Física, Fisioterapia e Terapia Ocupacional,
11 Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil
c
12 Associação Mineira de Reabilitação, Belo Horizonte, MG, Brazil
d
13 Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil
14 Received 20 June 2016; received in revised form 25 September 2016; accepted 26 September 2016
15 KEYWORDS Abstract
16 Cerebral palsy; Background: Therapeutic suits or clothing whether associated with intensive protocols or not,
17 Dynamic orthosis; became popular in the rehabilitation of children with cerebral palsy. Studies have reported pos-
18 Therapeutic vests; itive effects of these suits on children’s posture, balance, motor function and gait. A summary
19 Posture; of current literature may help guide therapeutic actions.
20 Movement; Objective: To evaluate the available evidence on the effects of interventions based on the use
21 Rehabilitation of therapeutic suits in the treatment of impairments and functional limitations of children with
22 cerebral palsy.
23 Method: Three independent reviewers searched for experimental studies on MEDLINE, SciELO,
24 BIREME, LILACS, PEDro and CENTRAL databases, between October and December 2015 and
25 updated in May 2016. The reviewers evaluated the methodological quality of selected stud-
26 ies using the Checklist for Measuring Quality. The Grading of Recommendations Assessment,
27 Development and Evaluation was used to synthesize the quality of evidence and strength of
28 recommendation.
29 Results: From the 13 studies, two evaluated the Full Body Suit, two tested the Dynamic Elas-
30 tomeric Fabric Orthose, three evaluated TheraTogs and six tested the TheraSuit/AdeliSuit
31 protocols. The quality of evidence for the Full Body Suit, the Dynamic Elastomeric Fabric
32 Orthose and the TheraSuit/AdeliSuit protocols was very low for body structure and function
33 outcomes, while the evidence for TheraTogs was low quality. Regarding the activity outcomes,
34
∗
Corresponding author at: Programa de Pós-Graduação em Ciências da Reabilitação, Escola de Educação Física, Fisioterapia e Terapia
Ocupacional, Universidade Federal de Minas Gerais, Av. Antônio Carlos, 6627, Pampulha, CEP: 31270-010, Belo Horizonte, MG, Brazil.
E-mails: mcmancini@ufmg.br, marisacmancini@gmail.com (M.C. Mancini).
http://dx.doi.org/10.1016/j.bjpt.2017.06.009
1413-3555/© 2017 Published by Elsevier Editora Ltda. on behalf of Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia.
Please cite this article in press as: Almeida KM, et al. Effects of interventions with therapeutic suits (clothing) on
BJPT 51
impairments and functional limitations of children with cerebral palsy: a systematic review. Braz J Phys Ther. 1---14
2017,
+Model
2 K.M. Almeida et al.
35 the Full Body Suit and TheraSuit showed very low quality evidence while the evidence for
36 TheraSuit/AdeliSuit protocols were of low quality.
37 Conclusion: Enthusiasm with new therapeutic approaches that argue modifications in the neu-
38 romusculoskeletal impairments and functional limitations of children with cerebral palsy need
39 to be guided by scientific evaluation. The low quality of evidence suggests caution in recom-
40 mending the use of these therapeutic suits. New studies could change the findings of this
41 review.
42 © 2017 Published by Elsevier Editora Ltda. on behalf of Associação Brasileira de Pesquisa e
43 Pós-Graduação em Fisioterapia.
44 Introduction system. These elastic elements are systematically adjusted 91
based on individual needs and limitations.5,8 In addition 92
45 Rehabilitation of children with cerebral palsy (CP) has to the clinical claims and families’ positive expectations, 93
46 focused on minimizing impairments and disabilities, promot- studies have provided scientific evidence on the effects of 94
47 ing functioning in patients’ body structures and functions, these suits regarding posture and movement of children with 95
48 activity and participation,1 in addition to improving their CP.13,16 96
49 quality of life.2 New technologies have been used to sup- A recent systematic review with meta-analysis showed 97
50 port and/or enhance the engagement of these children in that the effect of TSM and AST protocols on the func- 98
51 activities and tasks in different environments.2 One exam- tioning of children with CP was of small magnitude.13 As 99
52 ple is the use of rigid and dynamic orthoses. These devices this review focused on specific intensive training proto- 100
53 are intended to improve posture and movement, prevent cols, which involved elements other than suit wearing, no 101
54 deformities, and facilitate functional performance.3 conclusions regarding the effects of alternative types of 102
55 Since the 1990s, different types of therapeutic suits have therapeutic suits (e.g., TheraTogs) worn by children with 103
56 been used for children with CP.4---6 These suits are dynamic CP irrespectively of intensive training can be drawn. More- 104
57 orthoses available in various models. Body suit type orthoses over, given that the commercially available interventions 105
58 are custom manufactured, made of Lycra, fit tight to the include therapeutic suits associated or not with intensive 106
59 body and may cover the trunk and limbs, exerting a com- protocols, it is necessary to evaluate the isolated and com- 107
60 pressive force on the body.4,7 TheraTogs are elastic straps bined effects of these two elements (i.e., intensive training 108
61 attached by Velcro onto a vest, onto shorts and onto anchors and suit wearing). It is possible that positive evidence of 109
62 on the legs and feet. These technologies are intended to one element does not reflect the effect of the other, nor 110
63 improve postural alignment, joint stability and movement the combination of both. Therefore, the objective of this 111
64 efficiency.8 systematic review was to evaluate the available evidence 112
65 TheraSuit, AdeliSuit and PediaSuit were created from regarding the effects of interventions based on the use of 113
66 a prototype developed for Russian astronauts so they therapeutic suits (combined or not with intensive protocols) 114
67 could perform counter-resistance exercises in zero gravity on the treatment of functional limitations and disabilities 115
68 situations.5,9,10 These models have hooks that anchor a sys- in children with CP. The summary and critical analysis of 116
69 tem of individually fixed elastic tubes that exert traction this literature may guide clinical decision making regarding 117
70 between the trunk and pelvis and between the pelvis and these resources and provide scientific evidence to enable 118
71 lower limbs.9 They have become popular in many countries rehabilitation services to make judicious choices about the 119
72 and are often associated with specific treatment protocols. provision of these types of treatment. 120
73 The TheraSuit Method (TSM) and AdeliSuit Therapy (AST)

74 protocols9,11,12 consist of intensive treatments, including vig-
75 orous strengthening and stretching exercises and training of Methods 121
76 specific motor activities, during which the child wears the

77 suits.9,13 Three independent examiners performed literature 122
78 Therapeutic suits have gained popularity in pediatric searches on MEDLINE, SciELO, BIREME, LILACS, PEDro and 123
79 rehabilitation and are widely commercialized. Families of Cochrane Central Register of Controlled Trials databases. 124
80 children with CP have made efforts to acquire these suits and The searches were conducted between October and 125
81 submit their children to these very expensive supplemen- December 2015 and updated in May 2016. These searchers 126
82 tary treatments.12---16 There are clinical claims that the use were standardized and involved no restrictions of year of 127
83 of these dynamic orthoses can modify joint alignment and publication. The search strategy, along with the inclusion 128
84 contribute to the strengthening and/or stretching of certain and exclusion criteria, is shown in Table 1. As the use of 129
85 muscle groups, thereby affecting posture, balance, coor- therapeutic suits in child rehabilitation is a relatively new 130
86 dination, gross motor function, hand function and gait of modality of treatment, studies with different experimental 131
87 children with CP and other health conditions.4---11 The mech- designs were included. 132
88 anisms of action proposed to explain such functional changes After reading the titles and abstracts, duplicate stud- 133
89 are the compression and/or continuous tension exerted by ies or studies that did not meet the inclusion criteria were 134
90 the suits’ elastic elements on the child’s musculoskeletal excluded. The remainder were selected for full reading. An 135
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Therapeutic suits in CP 3
Studies identified from the search in the

databases (n=273)
Additional studies identified by other sources,
Identification
MEDLINE (n=92)
SCIELO (n=2) including active manual search (n=3)
BIREME (n=98)
LILACS (n=3)
COCHRANE (n=59)
PEDro (n=19)
Selection
Studies after removal by duplicity

(n=138)
Excluded by not attending

the inclusion criteria
(n=121)
Studies selected for reading in full

Elegibility
(n=17)
Excluded (n=4): absence of

inferential statistics (n=3);
no description of suit
intervention (n=1).
Included
Studies included in this review

(n=13)
Figure 1 Flowchart illustrating the article selection process, according to the PRISMA17 structure for a systematic review on the
effects of interventions with therapeutic suits on impairments and functional limitations of children with cerebral palsy.
136 active manual search on the articles’ reference lists was items are given a score of zero (0) if the study does 158
137 performed to identify potentially relevant studies. Fig. 1 not meet the requirements or a score of one (1) if the 159
138 illustrates the selection process.17 study meets the item requirements. Item 27 on statistical 160
139 The following data was extracted from the selected power is scored between zero (0) and five (5), with higher 161
140 articles: author and year of publication; study design; sam- scores for studies with larger samples. Item five, related 162
141 ple size and characteristics; details of the intervention: to principal confounders, is scored between zero (0) and 163
142 frequency, duration, suit type and settings, activities per- two (2). The maximum possible score is 32.18 Interrater 164
143 formed and control intervention; outcomes analyzed using reliability for the use of the checklist has been verified 165
144 inferential statistics and the instrumentation used; and the using the Intraclass Correlation Coefficient (ICC) type 2.1, 166
145 results obtained. Due to heterogeneity regarding the ther- a coefficient that measures absolute agreement with two- 167
146 apeutic suits types, intervention protocols and samples’ way random analysis.20 Consensus regarding disagreements 168
147 characteristics across the studies, it was not possible to between examiners in the checklist application was reached 169
148 conduct a meta-analysis. after a discussion mediated by the first author. 170
149 Each study’s methodological quality was evaluated inde- The Grading of Recommendations Assessment, Devel- 171
150 pendently by three examiners using the Checklist for opment and Evaluation (GRADE)21,22 summarized evidence 172
151 Measuring Study Quality,18 which is a valid and reliable regarding the therapeutic suits effects on each functioning 173
152 instrument recommended to be used in systematic reviews component1 and classified the strength of the recommen- 174
153 that include studies with different experimental designs.18,19 dation for this therapeutic resource. In GRADE, evidence is 175
154 The checklist evaluates the methodological quality of arti- initially categorized into four levels (i.e., high, moderate, 176
155 cles according to the following aspects: reporting (10 items); low, and very low) depending on the study design. After- 177
156 external validity (3 items); internal validity --- bias (13 wards, several methodological attributes from the studies 178
157 items); and statistical power (one item).18,19 Twenty-five are taken into account and may cause the level of quality 179
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clinical types of CP, aged between three and 17 years, 199

Table 1 Search strategy, inclusion and exclusion criteria
with Gross Motor Function Classification System (GMFCS)23 200
for a systematic review on the effects of interventions with
levels between I and IV, made up the sample. In terms 201
therapeutic suits on impairments and functional limitations
of the designs, six studies were Randomized Controlled 202
of children with cerebral palsy.
Trials (RCTs), five were quasi-experimental designs (QED), 203
Search terms and Cerebral palsy AND: Lycra and two were single-subject experimental designs (SSED). 204
expressions garments; Interventions with the suits ranged from three to 18 weeks, 205
TheraSuit; with usage times ranging between 30 min and 12 h/day. 206
Compression clothing; Different standardized instruments evaluated outcomes 207
Space suit; focusing on (1) body structures and functions and (2) 208
AdeliSuit; activity.1 A summary of the studies is presented in Table 2. 209
TheraTogs;
PediaSuit;
Suit therapy;
Dynamic Elastomeric Fabric Orthose 210
Penguin suit;
Dynamic orthoses Two studies tested the effects of DEFO (neoprene pants that 211
exert pressure on the pelvis and promote hip external rota- 212
Inclusion criteria Participants: children and tion and abduction and knee extension)24,25 on children with 213
adolescents with cerebral diplegic CP presenting with a crouch gait. In both studies, 214
palsy. subjects wore the suit from four to eight hours a day for 215
Type of study design: clinical six weeks. Matthews et al.24 showed that five of the eight 216
trial (controlled or not), subjects significantly increased walking speed after inter- 217
quasi-experimental, vention compared to baseline. The fact that only some of 218
single-case experimental study. the participants showed improvements might be attributed 219
Objective: evaluate the effect to (1) the lack of control of the activities performed by 220
of using therapeutic suits on each participant during the intervention period and (2) the 221
outcomes from the body lack of standardization regarding suit usage time among 222
structure and function and/or children.24 Bahramizadeh et al.25 showed improvement in 223
activity ICF components. knee alignment in the standing position, in the DEFO wearing 224
Language: English, Portuguese assessment condition, after the intervention period. Wear- 225
or Spanish. ing this suit did not lead to significant difference in postural 226
Exclusion criteria Studies that did not describe control between CP and normally developing children.25 227
the procedures of the

therapeutic suit intervention. The Full Body Suit 228
Studies that did not report the
inferential statistics used to
Two studies, conducted by the same group of researchers, 229
analyze the investigated
investigated the effects of the FBS.26,27 In these studies, chil- 230
outcomes.
dren wore the suit for up to six hours/day for six weeks while 231
maintaining their usual treatments and orthoses.26,27 Nichol- 232
son et al.27 revealed significant differences in self-care and 233

180 of the evidence available for each outcome to be increased mobility skills and in mobility independence, whereas Ren- 234
181 (i.e., large effect size, dose-response gradient, and residual nie et al.26 found no effect on any Pediatric Evaluation of 235
182 confounding factors that increase the confidence in the esti- Disability Inventory (PEDI) scales nor on proximal and distal 236
183 mate) or decreased (i.e., methodological limitations, risk of stability during walking. It is possible that the discrepancy 237
184 bias, inconsistency, inaccuracy, indirect evidence and pub- in their results might be attributed to type II error, wherein 238
185 lication bias).21,22 The strength of the recommendation is one study’s small sample size26 precluded demonstration of 239
186 classified as strong or weak and expresses an indication that the effects that were shown in the other study.27 240
187 a treatment should be adopted in clinical practice or not
188 by considering potential advantages and disadvantages.21,22
189 The GRADE recommendations were performed by the first TheraTogs 241
190 author.
Three studies tested the effects of TheraTogs in children 242
with diplegic CP wearing the suits for 12 h/day for 12 243

191 Results weeks.28---30 El-Kafy and El-Shemy28 compared a control 244
group (CG) submitted to an exercise program, with an 245
192 From an initial total of 273 articles, 13 met the criteria experimental group (EG) who undertook the same program 246
193 and were included in this review (Fig. 1). The studies were in addition to wearing TheraTogs. Their results showed a 247
194 published between 2000 and 2015. Two studies investigated significant difference between groups for postural align- 248
195 the effects of the Full Body Suit (FBS), two investigated ment and gait kinematics, favoring the EG. Within-groups 249
196 the Dynamic Elastomeric Fabric Orthose (DEFO), three comparison revealed that CG did not improve after treat- 250
197 investigated TheraTogs, and six investigated the TSM ment. In addition, after the intervention, evaluation of the 251
198 or AST protocols. A total of 285 children with different EG wearing the suit revealed significant improvements in 252
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Therapeutic suits in CP
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impairments and functional limitations of children with cerebral palsy: a systematic review. Braz J Phys Ther.
Table 2 Summary of evidence from studies investigating the effects of therapeutic suits associated or not with intensive protocols.
Author/year Study design Sample Intervention Variables/instruments Outcomes
Matthews SSED --- ABA. Each 8 children; 3---13 years; DEFO 8 h/daily (mean = 6.9 h), 6 Gait speed (10-Meter Five out of 8 children presented a
et al., phase lasted 6 diplegic CP; crouch weeks. Usual rehabilitation sessions Walking Test). statistically significant improvement in gait
200924 weeks. gait; GMFCS I---III. were maintained. speed between phases A1 (baseline) and B
(intervention) (p < 0.05 --- celeration line).
Bahramizadeh QED. EG: 10 children; 5---11 EG: DEFO 4---6 h/daily, 6 weeks. GC: no EG: Knee joint angle in The EG showed a statistically significant
et al., Assessments: EG years; diplegic CP; intervention. the standing position reduction in knee flexion in the standing
201525 baseline (without crouch gait; GMFCS (electrogoniometer). position post intervention compared to
suit) and I---II. CG: 10 typically EG and CG: postural baseline (p = 0.009), with large effect
post-treatment developing children, control by means of (d = 2.54). No significant differences
(with suit); CG age and weight velocity and between groups (p > 0.05) were identified
(single matched. displacement of the for postural control variables.
ARTICLE IN PRESS
assessment). center of gravity
(force plate).
Rennie et al., QED. 7 children with CP; Full body suit (Kendall-Camp UK Ltd), Proximal and distal No significant differences in gait stability
200026 Assessments: 5---11 years; spasticity, 6 h/daily, 6 weeks. Usual physiotherapy stability during gait or PEDI scores post intervention compared
baseline (without athetosis, hypotonia; treatment as well as the use of (3D-MAS); FS and CA to baseline.
suit) and able to walk 5 m orthotic devices were maintained (PEDI)
post-treatment without support. 1 during the intervention although
(with suit). child with Duchenne neither of them have been described.
muscular dystrophy.
Nicholson QED. 12 children; 2---17 Full body suit (Kendall-Camp UK Ltd), FS and CA (PEDI) PEDI-FS: significant improvement in
et al., Assessments: years; athetosis, 6 h/daily, 6 weeks. Usual rehabilitation self-care (p < 0.01) and mobility (p < 0.05)
200127 baseline (without ataxia, spastic, treatment as well as the use of post intervention. PEDI-CA: significant
suit) and hemiplegic, orthotic devices were maintained improvement in mobility (p < 0.05) post
post-treatment quadriplegic, diplegic. during the intervention although intervention.
(without suit). GMFCS level not neither of them have been described.
informed.
El-Kafy and RCT: 2 groups. 30 children; 6---8 years; CG: postural reactions facilitation, Rotational angles of Between groups: statistically significant
El-Shemy, Assessments: diplegic CP; crouch postural correction while walking, gait the hip and knee in differences for all the kinematic
201328 baseline (without gait; GMFCS I---II. training, 2 h/daily, 3 days/week, 12 the standing position, parameters, favoring the EG (p < 0.01),
suit) and Subjects were weeks. EG: same intervention as CG in Foot progression angle with large effect (1.0 < d < 1.91).
post-treatment randomized in 2 addition of wearing TheraTogs for during the gait cycle Within-groups: CG: no significant
(two conditions: groups: CG (n = 15) and 12 h/daily (except on weekends). and gait speed differences post-treatment (p > 0.05); EG:
wearing and not EG (n = 15). Elastic straps were positioned so as to (3D-MAS). significant differences between the three
wearing the suit favor femur’s external rotation and assessments for all the kinematic
for the EG). tibia’s internal rotation. parameters; the ‘‘wearing suit’’ condition
BJPT 51
was the one in which participants showed

the best results (p < 0.01), with large effect
2017,
CG vs EG ‘‘wearing suit’’ (2.79 < d < 3.98).

1---14
5
6
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Table 2 (Continued)

El-Kafy, RCT: 3 groups. 51 children; 6---8 years; CG: NDT, 2 h/daily, 5 days/week, 12 Gait kinematics: hip Between groups: statistically significant
201429 Assessments: diplegic CP; crouch weeks. EG1: NDT in addition of and knee flexion differences between groups for all the
baseline (without gait; GMFCS I---II. wearing TheraTogs 12 h/daily (elastic during the stance kinematic parameters, favoring the EG2
suit) and Subjects were straps were positioned so as to favor phase; gait speed; (p < 0.05), with small to large effect CG vs
post-treatment randomized in 3 femur’s external rotation and tibia’s cadence; step length. EG1 (0.25 < d < 1.48) and large effect CG vs
(without suit). groups: CC (n = 18), EG1 internal rotation). EG2: same as EG1 in Rotational angles of EG2 (1.03 < d < 3.10). EG1 vs EG2: no
(n = 16), EG2 (n = 17). addition of wearing GRO during the hip and knee significant differences between groups for
treatment sessions. during the stance the rotational angles of hip and knee
phase were assessed in (p > 0.05). Within-groups: significant
EG1 and EG2 (3D-MAS). improvements in all kinematic parameters
ARTICLE IN PRESS
were observed in the three groups
(p < 0.05), with large effect
(0.97 < d < 4.96).
Flanagan QED. 5 children; 7---13 years; TheraTogs 10---12 h/daily, 12 weeks. Gait kinematics Gait kinematics: significant improvement
et al., Assessments: diplegic CP; GMFCS I. Individual suit adjustment. All subjects (3D-MAS); gross motor in peak hip extension and pelvis alignment
200930 baseline, received elastic straps for oblique and abilities and balance post-treatment wearing the suit vs the
post-treatment erector spinae muscles. Participants (BOTMP); performance other assessment conditions. No changes in
(wearing and not did not receive other therapies during and satisfaction gait speed, cadence or step length were
wearing the suit), the intervention period. perceived by the identified. BOTMP: significant difference
follow-up (2 and 4 caregiver regarding between baseline and post-treatment not
months after the performance of wearing the suit (p = 0.025) moderate
intervention --- no functional tasks effect (d = 0.76), post-treatment wearing
suit). (COPM). the suit (p = 0.023) large effect (d = 0.89),
follow-up 2 months (p = 0.007) moderate
effect (d = 0.70) and follow-up 4 months
(p = 0.02) large effect (d = 0.96). COPM: no
significant improvement with the exception
of satisfaction after follow-up 2 months.
Alagesan and RCT: 2 groups. 30 children; 4---12 CG: conventional therapy (active limb Gross motor function Between groups: significant differences in
Shetty, Assessments: years; diplegic CP. movements, muscle strengthening and (GMFM-88). GMFM-88 scores between groups, favoring
201131 baseline and Subjects were stretching, weight bearing and the EG (p = 0.03) with large effect
post-treatment. randomized in 2 shifting, orthostatic posture training, (d = 0.83). Within-groups: both groups
groups: CG (n = 15) and abnormal posture corrections, balance showed significant improvement in
K.M. Almeida et al.

EG (n = 15). training, gait training and stair GMFM-88z scores after intervention
climbing training), 2 h/daily, 5 (p < 0.001), with small effect to CG
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days/week, 3 weeks. EG: same as CG (d = 0.11) and small effect to EG (d = 0.4)

in addition of wearing TheraSuit.
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Table 2 (Continued)

Bailes et al., RCT. 2 groups. 20 children; 3---8 years; EG: TheraSuit Method, 4 h/daily, 5 Gross motor function Between groups: no significant differences
201132 Assessments: GMFCS III. Subjects days/week, 3 weeks. Subjects in EG (GMFM-66). FS and CA between groups neither in GMFM-66 scores
baseline, were randomized in 2 wore TheraSuit with the elastic (PEDI). (p = 0.48), nor in PEDI subscales scores
post-treatment groups: CG (n = 10) and bungee cords attached. CG: same (p > 0.18); the combined effect, although
(3---4 weeks), EG (n = 10). intervention method as EG, although of small magnitude, was positive for all the
follow-up (4 subjects in this group wore a ‘‘control outcome variables (0.17 < d < 0.23), except
weeks). suit’’ (TheraSuit without the elastic for PEDI-CA mobility, which was negative
(d = −0.37). Within-groups: EG significant
ARTICLE IN PRESS
bungee cords attached).
improvement in PEDI-CA self-care
post-treatment vs baseline (p = 0.04) small
effect (d = 0.19); significant improvement
in GMFM-66 scores (p = 0.002) small effect
(d = 0.37), PEDI-FS self-care (p = 0.04) and
mobility (p = 0.005) small effect
(0.20 < d = 0.25), PEDI-CA self care
(p = 0.01) small effect (d = 0.24) in the
follow-up vs baseline; PEDI-FS mobility in
the follow-up vs post-treatment (p = 0.03)
small effect (d = 0.14). CG: significant
improvement in GMFM-66 scores in the
follow-up vs baseline (p = 0.03) moderate
effect (d = 0.54).
Bar-Haim RCT: 2 groups. 24 children; 5---12 EG: Adelisuit Therapy, 2 h/daily, 5 Gross motor function Between groups: no significant differences
et al., Assessments: years; hemiplegic, days/week, 4 weeks. CG: NDT (GMFM-66). Energy between groups. Within-groups: EG ---
200633 baseline, quadriplegic, triplegic 2 h/daily, 5 days/week, 4 weeks. cost during significant improvement in GMFM-66 scores
post-treatment (4 CP; GMFCS II---IV. Participants did not receive other stair-climbing (MEI). (p < 0.03) small effect (d = 0.24)
weeks), follow-up Subjects were therapies during the intervention post-treatment vs baseline, MEI (p < 0.05)
(9 months). randomized in 2 period. with large effect (d = 1.53) in the follow-up
groups: EG (n = 12) and vs baseline, especially in children with
CG (n = 12). higher GMFM-66 scores. CG --- significant
improvement in GMFM-66 scores in the
follow-up vs baseline (p = 0.006) with
moderate effect (d = 0.62).
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8
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Table 2 (Continued)

Mahani et al., RCT. 3 groups. 36 children; mean CG: NDT (passive exercises in the first Gross motor function Between groups: significant differences
201134 Assessments: age = 7.78 years; hour and active exercises in the second (GMFM-66). (p = 0.000); the differences were between
baseline, diplegic, quadriplegic, hour). EG-AST: AdeliSuit Therapy. EG-MAST and EG-AST favoring the EG-MAST
post-treatment (4 spastic and dystonic EG-MAST: Modified AdeliSuit Therapy (p = 0.000) small effect (d = 0.41); and
weeks), follow-up CP; GMFCS I---IV. (NDT in the first hour and AdeliSuit in between EG-MAST and CG favoring the
(16 weeks). Subjects were the second hour). Subjects in all 3 EG-MAST (p = 0.000) moderate effect
randomized in 3 groups were treated for 4 weeks (d = 0.56); no significant differences
groups: CG (n = 12), (2 h/daily, 5 days/week). between EG-AST and CG (p = 0.272).
EG-AST (n = 12) and Within-groups: the 3 groups improved in
EG-MAST (n = 12). GMFM-66 scores post-treatment vs baseline
(p < 0.001) with small to large effect
(0.29 < d < 0.88); no significant differences
ARTICLE IN PRESS
within-groups were identified in the
follow-up (p = 0.637).
Christy et al., QED. 17 children; 4---12 TheraSuit Method, 4 h/daily, 5 Gross motor function Post-treatment vs baseline: significant
201235 Assessments: years; spastic, days/week, 3 weeks. (GMFM-66). improvement in GMFM-66 scores (p < 0.001)
baseline, hypotonic, athetosis, Performance in small effect (d = 0.24), COPM (p < 0.001)
post-treatment (3 ataxia, quadriplegic, community walking large effect (2.25 < d < 2.83) and PODCI
weeks), follow-up diplegic and triplegic (SAM). Global (p = 0.001) small effect (d = 0.45).
(3 months). CP; GMFCS I---III. functionality (PODCI). Follow-up vs baseline: significant
Performance and improvement in GMFM-66 scores (p = 0.01)
satisfaction perceived small effect (d = 0.21) and COPM (p < 0.001)
by the caregiver large effect (1.74 < d < 2.15). No significant
regarding the differences in community walking
performance of performance (SAM).
functional tasks
(COPM).
Ko et al., SSED --- AB. Phase 1 child; 8 years; Phase A: baseline. Phase B Gait speed (10-Meter There was significant improvement in gait
201436 A: 6 weeks; Phase diplegic CP; crouch (intervention): AdeliSuit Therapy, Walking Test). Gross speed (p = 0.014), GMFM-88 (p = 0.012) and
B: 18 weeks. gait; GMFCS III. 50 min sessions, 1 day/week, 18 motor function PBS scores (0.001) in phase B compared to
weeks. Each session was divided into (GMFM-88). Balance baseline (two-standard deviation band
10 min preparation, 10 min muscle (PBS). method).
strengthening and 30 min gait training
with AdeliSuit on. Usual physical and
K.M. Almeida et al.

occupational therapies were
maintained twice a week.
SSED, single-subject experimental design; CP, cerebral palsy; GMFCS, Gross Motor Function Classification System; DEFO, Dynamic Elastomeric Fabric Orthoses; QED, quasi-experimental
BJPT 51
design; EG, experimental group; CG, control group; 3D-MAS, three-dimensional motion analysis system; PEDI, Pediatric Evaluation of Disability Inventory (FS, Functional Skills Scale;
CA, Caregiver Assistance Scale); BOTMP, Bruininks-Oseretsky Test of Motor Proficiency; COPM, Canadian Occupational Performance Measure; RCT, randomized controlled trial; NDT,
2017,
neurodevelopmental treatment; GRO, ground reaction orthosis; GMFM, Gross Motor Function Measure; MEI, Mechanical Efficiency Index; SAM, Step Watch Activity Monitor; PODCI,
1---14
Pediatric Outcomes Data Collection Instrument; PBS, Pediatric Balance Scale.

+Model
253 all parameters compared to the conditions without the suit analyzing the effects of FBS obtained scores of 37%26 and 310
254 evaluated before and after intervention.28 El-Kafy29 com- 40%,27 studies of DEFO obtained 43%24 and 53%,25 Ther- 311
255 pared the following three groups: CG --- neurodevelopmental aTogs studies obtained 37%,28 59%29 and 68%,30 TSM and AST 312
256 treatment (NDT); EG1 --- NDT plus TheraTogs; and EG2 --- NDT studies31---36 scored between 34% and 90% of the total check- 313
257 plus TheraTogs and ground reaction orthosis. After the inter- list value. Overall, the studies obtained good scores in the 314
258 ventions, although the three groups showed improvements description of objectives, methods and results. Low scores 315
259 in all gait kinematic parameters, EG2 showed better results were related to external validity items and the blinding of 316
260 than CG and EG1, demonstrating that combining rigid and subjects, therapists and examiners. The item regarding con- 317
261 dynamic orthoses might potentiate gait performance in sistency in the intervention was scored only by studies that 318
262 diplegic children with a crouch gait.29 Flanagan et al.30 verified the effects of TSM and AST; studies evaluating the 319
263 demonstrated a positive effect of TheraTogs on gross motor effects of FBS, DEFO and TheraTogs received a zero score 320
264 skills and balance after intervention and at follow-up. in this item because they did not provide information about 321
265 Changes in gait kinematics were found with the suit on the control of suit usage time. Most studies obtained a max- 322
266 (i.e., increase in peak hip extension and pelvic alignment). imum score on the item related to statistical power (score 323
267 Even after prolonged use, the effects of TheraTogs were 5), because study groups had eight or more subjects, lead- 324
268 demonstrated only when children were wearing the suit.30 ing to the checklist’ criteria for maximum scoring on that 325
item.18 326
269 TheraSuit Method and AdeliSuit Therapy Protocols The summarized evaluation by GRADE suggests that the 327
quality of evidence on the use of the suits was low to very 328
270 Two studies 31,32

investigated the effects of the TheraSuit low for body structure and function and activity1 outcomes. 329
271 associated with intensive protocols on activity outcomes1 Such classification was primarily due to the small number 330
272 of children with CP. In both studies, participants were sub- of RCTs and to certain methodological limitations in the 331
273 mitted to exercise programs, with one group (EG) wearing studies, resulting in weak recommendations for the use of 332
274 the suit and the other group (CG) not wearing it. Alage- therapeutic suits. Table 4 shows the application of GRADE 333
275 san and Shetty31 found a significant improvement in gross with respect to the body of evidence available for the out- 334
276 motor function in the EG compared to the CG. Bailes et al.32 comes investigated for each suit. 335
277 found improvements in gross motor function, functional abil-

278 ities and caregiver assistance in both groups but found no
Discussion 336
279 difference between CG and EG post-treatment.32 Although
280 both studies showed significant effects following the use
This systematic review examined the available evidence on 337
281 of this suit, there were inconsistencies in groups’ compar-
the effects of therapeutic suits associated or not with inten- 338
282 isons due to differences in the treatment characteristics. For
sive protocols on the functioning of children with CP. Four 339
283 example, in the study by Alagesan and Shetty31 the exercise
main suit models were found in the 13 selected studies. Gen- 340
284 program was based on conventional therapy, whereas Bailes
erally, the postural alignment and gait kinematic improved 341
285 et al.32 used the original TSM protocol.
in children with CP who wore the suits, especially when they 342
286 Two studies33,34 compared AST to NDT and found no dif-
were wearing them. However, the quality of evidence is low 343
287 ference in gross motor function in groups of children with
and the recommendation for therapeutic suits in the treat- 344
288 different CP types. Mahani et al.34 also compared NDT and
ment of impairments and limitations of children with CP 345
289 AST to the modified AST (MAST) protocol, which associates
is weak due to uncertainty regarding the advantages and 346
290 NDT and AST techniques. The group submitted to MAST
disadvantages of wearing the investigated suits. 347
291 showed better results in gross motor function, revealing the
The review did not find any effect arising from the iso- 348
292 positive effects of combining a traditional technique with
lated use of TheraSuit and AdeliSuit without an associated 349
293 the use of this therapeutic suit.34 Christy et al.35 investi-
intensive treatment protocol in the functioning of children 350
294 gated the effects of TSM on 17 children with CP and found
with CP. The association of the suits with intensive protocols 351
295 a significant improvement in gross motor function, over-
(e.g., TSM/AST) has increased expectations of good results 352
296 all functioning, performance and satisfaction perceived by
in the rehabilitation of children and youth with CP.2,12,14,15 353
297 caregivers regarding children’s performance of functional
Among the selected studies, Bailes et al.,32 with better 354
298 tasks.35 Ko et al.36 evaluated the effects of AST in a child
methodological quality, showed that there was no differ- 355
299 with diplegic CP undergoing weekly sessions for 18 weeks.
ence in the gross motor function and functional skills of 356
300 Improvements in gross motor function, gait speed and bal-
children with CP when submitted to the TSM with or with- 357
301 ance were observed.36
out the suit. The effects found might be due to the intensity 358
of treatment and cannot be attributed to the isolated use 359

302 Evaluation of the methodological quality of the of TheraSuit.32 In addition, Bar-Haim et al.33 and Mahani 360
303 studies et al.34 revealed no difference between those interventions 361
and other therapies when performed with the same intensity 362
304 The consistency of the three researchers regarding the use and duration. It is possible that the high intensity of train- 363
305 of the Checklist for Measuring Quality for measuring study ing, instead of the specificity of the TSM and AST protocols, 364
306 quality18 was very good20 (ICC2.1 = 0.89 ± 0.09). Table 3 shows may be responsible for the improvements presented by the 365
307 the scoring for each study for each item. Scores varied children submitted such interventions. This review corrob- 366
308 according to the design, with higher values obtained by orates a recent systematic review and meta-analysis13 that 367
309 RCTs,29---34 followed by QEDs25---28,35 and SSEDs.24,36 Studies examined the effects of these therapies on the functioning 368
BJPT 51
2017,
10
BJPT 51 1---14
+Model
Table 3 Evaluation of the methodological quality of studies on the effects of interventions with therapeutic suits on impairments and functional limitations of children with
cerebral palsy using the Checklist for Measuring Qualitya .
Checklist items Selected studies
Matthews Bahramizadeh Rennie Nicholson El-Kafy El- Flanagan Alagesan Bailes Bar-Haim Mahani Christy Ko
et al.24 et al.25 et al.26 et al.27 and El- Kafy29 et al.30 and et al.32 et al.33 et al.34 et al.35 et al.36
Shemy28 Shetty31
Reporting
1. Hypothe- 1 1 0 1 1 1 1 1 1 1 1 1 1
sis/aim/objective
2. Outcomes 1 1 1 1 1 1 1 1 1 1 1 1 1
3. Inclusion/exclusion 1 1 1 0 1 1 1 1 1 1 1 1 1
criteria
ARTICLE IN PRESS
4. Interventions 1 1 1 1 1 1 1 1 1 1 1 1 1
5. Principal 0 0 0 0 0 0 0 0 2 0 0 0 0
confounders
6. Findings 0 1 1 1 1 1 0 1 1 1 1 1 1
7. Random variability 0 1 0 0 1 1 0 1 1 1 1 1 1
8. Adverse events 1 0 1 1 0 0 1 0 1 0 0 1 0
9. Lost to follow-up 1 0 0 0 0 0 1 0 1 1 1 1 0
10. Probability values 0 1 0 0 1 1 0 1 1 1 1 1 1
External validity
11. Subjects asked to 0 0 0 0 0 0 0 0 0 0 0 0 0
participate
representative of
population
12. Subjects prepared 0 0 0 0 0 0 0 0 0 0 0 0 0
to participate
representative of
population
13. Representative of 1 1 1 1 1 1 1 1 1 1 1 1 0
the treatment
Internal validity
14. Blinding subjects 0 0 0 0 0 0 0 0 1 0 0 0 0
to the intervention
15. Blinding of 0 0 0 0 0 1 0 1 1 0 1 0 0
K.M. Almeida et al.

examiners
16. Clear ‘‘data 0 1 0 0 1 1 0 1 1 1 1 1 0
dredging’’
BJPT 51
17. Adjust for 0 0 0 0 0 0 0 0 1 1 1 0 0

different lengths of
2017,
follow-up
1---14
BJPT 51 1---14
+Model
Table 3 (Continued)
Checklist items Selected studies
Matthews Bahramizadeh Rennie Nicholson El-Kafy El- Flanagan Alagesan Bailes Bar-Haim Mahani Christy Ko
et al.24 et al.25 et al.26 et al.27 and El- Kafy29 et al.30 and et al.32 et al.33 et al.34 et al.35 et al.36
Shemy28 Shetty31
18. Appropriate 1 1 0 1 1 1 0 1 1 1 1 1 1
statistical tests
19. Reliable 0 0 0 0 0 0 0 0 1 1 1 1 1
compliance with the
intervention
ARTICLE IN PRESS
20. Accurate outcome 1 1 1 1 1 1 1 1 1 1 1 1 1
measures
21. Recruitment 0 0 0 0 1 1 0 1 1 1 1 0 0
population of subjects
22. Recruitment 0 1 0 0 1 1 0 1 1 1 1 0 0
period of time of the
subjects
23. Randomization 0 0 0 0 1 1 0 1 1 1 1 0 0
groups
24. Concealed 0 0 0 0 0 1 0 0 0 0 0 0 0
randomized
intervention
assignment from
patients and staffs
25. Adjustment for 0 0 0 0 0 1 0 0 1 1 0 0 0
confounding
26. Losses of subjects 0 0 0 0 0 0 1 0 1 0 1 0 0
to follow-up
Power
27. Sufficient power to 5 5 5 5 5 5 3 5 5 5 5 5 1
detect a clinically
effect/sample sizes
Study total score 14 17 12 13 19 22 12 20 29 23 24 19 11
Percentage (%)b 43 53 37 40 59 68 37 62 90 71 75 59 34
Q4 a Downs and Black.18
BJPT 51
b Percentage of total score of the study according to the Checklist’s total score (32 points).
2017,
1---14
11
12
BJPT 51 1---14
+Model
Table 4 Evidence profile of the four models of therapeutic suits and intensive protocols associated with therapeutic suits.
Suits ICF-level outcome Studies Participants Outcome variables Comments Quality of Recommendation
evidence
DEFO Body structure Bahramizadeh 10 children with Postural alignment and Important Very low Weak
and function et al.25 CP control methodological
limitations
Activity Matthews et al.24 8 children with Gait velocity Important Very low
CP methodological
limitations
Full Body Suit Body structure Rennie et al.26 7 children with Gait stability Effect was not Very low Strong (---)
and function CP reported
ARTICLE IN PRESS
Activity Rennie et al.26 and 19 children with Functional skills, Important Very low
Nicholson et al.27 CP caregiver assistance methodological
limitations, results
inconsistency
TheraTogs Body structure El-Kafy and 86 children with Gait kinematics, postural Methodological Low Weak
and function El-Shemy28 , CP alignment limitations
El-Kafy29 and
Flanagan et al.30
Activity El-Kafy29 and 56 children with Gait velocity, gross motor Methodological Low
Flanagan et al.30 CP function, perceived limitations
satisfaction and
performance
TheraSuita Activity Alagesan and 50 children with Gross motor function, Methodological Very low Weak
Shetty31 and Bailes CP functional skills, limitations, results
et al.32 caregiver assistance inconsistency
TheraSuit Body structure Bar-Haim et al.33 25 children with Energy cost, gait velocity, Methodological Very low Weak
Method/AdeliSuit and function and Ko et al.36 CP balance limitations,
Therapy indirect evidence
Activity Bailes et al.32 , 128 children with Gross motor function, Methodological Low
Bar-Haim et al.33 , CP functional skills, limitations, results
Mahani et al.34 , caregiver assistance, inconsistency
Christy et al.35 and global function,
K.M. Almeida et al.

Ko et al.36 perceived satisfaction
and performance
BJPT 51
ICF, International Classification of Functioning, Disability and Health; DEFO, Dynamic Elastomeric Fabric Orthoses; CP, cerebral palsy.
a Associated with intensive protocols.
2017,
1---14
+Model
369 of children with CP. The authors concluded that the avail- have hindered the identification of potentially relevant 431
370 able evidence was not sufficient to draw conclusions about studies. The Checklist for Measuring Study Quality presented 432
371 the advantages and disadvantages of the TSM and AST in the difficulties regarding the interpretation and application of 433
372 treatment of gross motor function of children with CP.13 some items, especially those concerning external validity, 434
373 The DEFO and TheraTogs demonstrated positive which caused disagreements between the evaluators. 435
374 effects24,25,28---30 on postural alignment and gait kine- These disagreements were minimized by discussion to 436
375 matics of children with diplegic CP. This type of child often reach a consensus. Finally, it was not possible to add a 437
376 presents with hip internal rotation and flexion, knee flexion, meta-analysis to this systematic review because the studies 438
377 and tibia internal rotation, resulting in a gait pattern named tested various therapeutic suit models in samples with 439
378 ‘‘crouch gait’’.37 Positive effects on the posture and gait of different characteristics and compared different protocols. 440
379 these children were previously documented with subjects

380 wearing rigid orthoses.3,38 Hence, the association of rigid Recommendations for future studies 441
381 orthoses with a therapeutic suit (i.e., a dynamic orthoses)
382 seems to potentiate the individual effects of each of these
The selected studies did not have sufficient information 442
383 interventions in the diplegic children’s gait kinematics.30
about (1) the direction and level of tension applied to the 443
384 While rigid orthoses provide greater joint stability, dynamic
elastic elements in order to adjust the suits and (2) the exer- 444
385 orthoses have the potential to facilitate the execution
cises and activities conducted during the therapy sessions. 445
386 of movements and their combination may perpetuate
Detailing the procedures is important since these elements 446
387 long-term positive changes in the musculoskeletal system
constitute the mechanisms underlying therapeutic changes. 447
388 of diplegic children.39,40
Additionally, there is a lack of studies with a high level of evi- 448
389 FBS, whose compressive characteristic aims to promote
dence that identified the dose-response of this therapeutic 449
390 stability, did not demonstrate any improvements in gait
resource (i.e., the sufficient and appropriate intensity and 450
391 stability when used in children with different CP types,
duration of suit wearing for the effects on different func- 451
392 even when the child was wearing the suit during the
tional components). Finally, the studies lacked information 452
393 assessments.26,27 Additionally, Rennie et al.26 and Nichol-
about which children with CP (i.e., descriptive characteris- 453
394 son et al.27 have reported parents’ complaints concerning
tics including age, topographic and severity) might be better 454
395 the discomfort associated with FBS, including changes in
candidates for obtaining the effects of different therapeu- 455
396 the urinary system and constipation, movement restrictions,
tic suit models. Most studies that were part of this review 456
397 warmth, and eczema. These discomforts contributed to
included only children with mild to moderate severity of CP 457
398 most children not enjoying the use of the suit and reporting
(GMFCS I---III) and with diplegic CP type, limiting the results 458
399 they would not consider wearing it again.26,27 Knox41 fol-
for these subgroups. 459
400 lowed a series of eight cases of children with CP who wore
401 a suit with the same compressive characteristics for four
402 weeks. Three children withdrew from participating in the Conclusion 460
403 study because they could not adapt to the suit. Those who
404 completed the intervention stated that the suit was tight, The suits DEFO and TheraTogs seem to improve the postural 461
405 hot, and difficult to put on and take off, with difficulties in alignment and gait performance in children with diplegic CP. 462
406 using the toilet.41 The very low evidence of FBS’s efficacy, However, the quality of current available evidence ranges 463
407 in association with its adverse effects, result in a strong rec- from low to very low for the different suit models tested. 464
408 ommendation that it should not be used in the rehabilitation The recommendation to use these suits in the treatment of 465
409 of children with CP. children with CP is weak. Future studies that address the 466
410 The intensity and duration of therapeutic suit treatment inconclusive elements indicated in this review may help to 467
411 varied greatly among the studies. Positive effects on body endorse or refute the effects of these dynamic orthoses and 468
412 structure and function outcomes were found in situations will most certainly affect the strength with which they can 469
413 of reduced intensity and duration25 (i.e., wearing DEFO for be recommended. 470
414 four to six hours/day for six weeks) as well as in situations

415 of higher intensity28---30 and duration (i.e., wearing Ther- Conflicts of interest Q2 471
416 aTogs for 12 h/day for 12 weeks). However, long-term effects
417 were not systematically investigated. Only Flanagan et al.,30 The authors declare no conflicts of interest. 472
418 investigated the isolated effects of TheraTogs, and found
419 stable gains in gross motor skills in the follow-up period.30
420 Due to the differences among therapeutic suits and the time Acknowledgements 473
421 regimens in which they were implemented, the available

422 evidence is not conclusive regarding the optimal intensity Financial support was granted by the Brazilian government 474
423 of suit wearing to guarantee their efficacy. agencies Conselho Nacional de Desenvolvimento Científico 475
424 This systematic review has limitations that need to e Tecnológico (CNPq), Coordenação de Aperfeiçoamento de Q3 476
425 be considered. The criteria for selecting studies was met Pessoal de Nível Superior (CAPES), Fundação de Amparo a 477
426 with a language restriction (only studies written in English, Pesquisa do Estado de Minas Gerais (FAPEMIG), and Labo- 478
427 Portuguese or Spanish were included), resulting in the ratório de Investigação Médica do Hospital das Clínicas da 479
428 exclusion of seven potentially relevant studies published in FMUSP --- LIM 34 (Ciências da Reabilitação). Funding from 480
429 Russian. Besides, no literature searches were conducted in CNPq (Universal 14/2012 --- Faixa B; Process: 477575/2012-9) 481
430 databases with no free access (e.g., EMBASE), which may paid for the English translation. 482
BJPT 51
2017,
+Model
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BJPT 51 1---14 ARTICLE IN PRESS

4 Effects of interventions with therapeutic suits

44 Introduction system. These elastic elements are systematically adjusted 91

based on individual needs and limitations.5,8 In addition 92

48 activity and participation,1 in addition to improving their CP.13,16 96

64 efﬁciency.8 systematic review was to evaluate the available evidence 112

73 The TheraSuit Method (TSM) and AdeliSuit Therapy (AST)

76 speciﬁc motor activities, during which the child wears the

Studies identified from the search in the

Studies after removal by duplicity

Excluded by not attending

Studies selected for reading in full

Excluded (n=4): absence of

Studies included in this review

clinical types of CP, aged between three and 17 years, 199

Compression clothing; Different standardized instruments evaluated outcomes 207

AdeliSuit; activity.1 A summary of the studies is presented in Table 2. 209

the procedures of the

maintaining their usual treatments and orthoses.26,27 Nichol- 232

son et al.27 revealed signiﬁcant differences in self-care and 233

with diplegic CP wearing the suits for 12 h/day for 12 243

group (CG) submitted to an exercise program, with an 245

was the one in which participants showed

CG vs EG ‘‘wearing suit’’ (2.79 < d < 3.98).

Author/year Study design Sample Intervention Variables/instruments Outcomes

K.M. Almeida et al.

days/week, 3 weeks. EG: same as CG (d = 0.11) and small effect to EG (d = 0.4)

Author/year Study design Sample Intervention Variables/instruments Outcomes

Author/year Study design Sample Intervention Variables/instruments Outcomes

K.M. Almeida et al.

Pediatric Outcomes Data Collection Instrument; PBS, Pediatric Balance Scale.

270 Two studies 31,32

277 found improvements in gross motor function, functional abil-

of treatment and cannot be attributed to the isolated use 359

K.M. Almeida et al.

17. Adjust for 0 0 0 0 0 0 0 0 1 1 1 0 0

Checklist items Selected studies

K.M. Almeida et al.

379 these children were previously documented with subjects

414 four to six hours/day for six weeks) as well as in situations

421 regimens in which they were implemented, the available

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