Rehabilitation of children with cerebral palsy (CP) has focused on minimizing impairments and disabilities, promoting functioning in patients’ body structures and functions, activity and participation,1 in addition to improving their quality of life.2 New technologies have been used to support and/or enhance the engagement of these children in activities and tasks in different environments.2 One example is the use of rigid and dynamic orthoses. These devices are intended to improve posture and movement, prevent deformities and facilitate functional performance.3

Since the 1990s, different types of therapeutic suits have been used for children with CP.4–6 These suits are dynamic orthoses available in various models. Body suit type orthoses are custom manufactured, made of Lycra, fit tight to the body and may cover the trunk and limbs, exerting a compressive force on the body.4,7 TheraTogs are elastic straps attached by Velcro onto a vest, onto shorts and onto anchors on the legs and feet. These technologies are intended to improve postural alignment, joint stability and movement efficiency.8

TheraSuit, AdeliSuit and PediaSuit were created from a prototype developed for Russian astronauts so they could perform counter-resistance exercises in zero gravity situations.5,9,10 These models have hooks that anchor a system of individually fixed elastic tubes that exert traction between the trunk and pelvis and between the pelvis and lower limbs.9 They have become popular in many countries and are often associated with specific treatment protocols. The TheraSuit Method (TSM) and AdeliSuit Therapy (AST) protocols9,11,12 consist of intensive treatments, including vigorous strengthening and stretching exercises and training of specific motor activities, during which the child wears the suits.9,13

Therapeutic suits have gained popularity in pediatric rehabilitation and are widely commercialized. Families of children with CP have made efforts to acquire these suits and submit their children to these very expensive supplementary treatments.12–16 There are clinical claims that the use of these dynamic orthoses can modify joint alignment and contribute to the strengthening and/or stretching of certain muscle groups, thereby affecting posture, balance, coordination, gross motor function, hand function and gait of children with CP and other health conditions.4–11 The mechanisms of action proposed to explain such functional changes are the compression and/or continuous tension exerted by the suits’ elastic elements on the child's musculoskeletal system. These elastic elements are systematically adjusted based on individual needs and limitations.5,8 In addition to the clinical claims and families’ positive expectations, studies have provided scientific evidence on the effects of these suits regarding posture and movement of children with CP.13,16

A recent systematic review with meta-analysis showed that the effect of TSM and AST protocols on the functioning of children with CP was of small magnitude.13 As this review focused on specific intensive training protocols, which involved elements other than suit wearing, no conclusions regarding the effects of alternative types of therapeutic suits (e.g., TheraTogs) worn by children with CP irrespectively of intensive training can be drawn. Moreover, given that the commercially available interventions include therapeutic suits associated or not with intensive protocols, it is necessary to evaluate the isolated and combined effects of these two elements (i.e., intensive training and suit wearing). It is possible that positive evidence of one element does not reflect the effect of the other, nor the combination of both. Therefore, the objective of this systematic review was to evaluate the available evidence regarding the effects of interventions based on the use of therapeutic suits (combined or not with intensive protocols) on the treatment of functional limitations and disabilities in children with CP. The summary and critical analysis of this literature may guide clinical decision making regarding these resources and provide scientific evidence to enable rehabilitation services to make judicious choices about the provision of these types of treatment.

Three independent examiners performed literature searches on MEDLINE, SciELO, BIREME, LILACS, PEDro and Cochrane Central Register of Controlled Trials databases. The searches were conducted between October and December 2015 and updated in May 2016. These searchers were standardized and involved no restrictions of year of publication. The search strategy, along with the inclusion and exclusion criteria, is shown in Table 1. As the use of therapeutic suits in child rehabilitation is a relatively new modality of treatment, studies with different experimental designs were included.

After reading the titles and abstracts, duplicate studies or studies that did not meet the inclusion criteria were excluded. The remainder were selected for full reading. An active manual search on the articles’ reference lists was performed to identify potentially relevant studies. Fig. 1 illustrates the selection process.17

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.

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The following data was extracted from the selected articles: author and year of publication; study design; sample size and characteristics; details of the intervention: frequency, duration, suit type and settings, activities performed and control intervention; outcomes analyzed using inferential statistics and the instrumentation used; and the results obtained. Due to heterogeneity regarding the therapeutic suits types, intervention protocols and samples’ characteristics across the studies, it was not possible to conduct a meta-analysis.

Each study's methodological quality was evaluated independently by three examiners using the Checklist for Measuring Study Quality,18 which is a valid and reliable instrument recommended to be used in systematic reviews that include studies with different experimental designs.18,19 The checklist evaluates the methodological quality of articles according to the following aspects: reporting (10 items); external validity (3 items); internal validity – bias (13 items); and statistical power (one item).18,19 Twenty-five items are given a score of zero (0) if the study does not meet the requirements or a score of one (1) if the study meets the item requirements. Item 27 on statistical power is scored between zero (0) and five (5), with higher scores for studies with larger samples. Item five, related to principal confounders, is scored between zero (0) and two (2). The maximum possible score is 32.18 Interrater reliability for the use of the checklist has been verified using the Intraclass Correlation Coefficient (ICC) type 2.1, a coefficient that measures absolute agreement with two-way random analysis.20 Consensus regarding disagreements between examiners in the checklist application was reached after a discussion mediated by the first author.

The Grading of Recommendations Assessment, Development and Evaluation (GRADE)21,22 summarized evidence regarding the therapeutic suits effects on each functioning component1 and classified the strength of the recommendation for this therapeutic resource. In GRADE, evidence is initially categorized into four levels (i.e., high, moderate, low, and very low) depending on the study design. Afterwards, several methodological attributes from the studies are taken into account and may cause the level of quality of the evidence available for each outcome to be increased (i.e., large effect size, dose-response gradient, and residual confounding factors that increase the confidence in the estimate) or decreased (i.e., methodological limitations, risk of bias, inconsistency, inaccuracy, indirect evidence and publication bias).21,22 The strength of the recommendation is classified as strong or weak and expresses an indication that a treatment should be adopted in clinical practice or not by considering potential advantages and disadvantages.21,22 The GRADE recommendations were performed by the first author.

From an initial total of 273 articles, 13 met the criteria and were included in this review (Fig. 1). The studies were published between 2000 and 2015. Two studies investigated the effects of the Full Body Suit (FBS), two investigated the Dynamic Elastomeric Fabric Orthose (DEFO), three investigated TheraTogs, and six investigated the TSM or AST protocols. A total of 285 children with different clinical types of CP, aged between three and 17 years, with Gross Motor Function Classification System (GMFCS)23 levels between I and IV, made up the sample. In terms of the designs, six studies were Randomized Controlled Trials (RCTs), five were quasi-experimental designs (QED), and two were single-subject experimental designs (SSED). Interventions with the suits ranged from three to 18 weeks, with usage times ranging between 30min and 12h/day. Different standardized instruments evaluated outcomes focusing on (1) body structures and functions and (2) activity.1 A summary of the studies is presented in Table 2.

This systematic review examined the available evidence on the effects of therapeutic suits associated or not with intensive protocols on the functioning of children with CP. Four main suit models were found in the 13 selected studies. Generally, the postural alignment and gait kinematic improved in children with CP who wore the suits, especially when they were wearing them. However, the quality of evidence is low and the recommendation for therapeutic suits in the treatment of impairments and limitations of children with CP is weak due to uncertainty regarding the advantages and disadvantages of wearing the investigated suits.

The review did not find any effect arising from the isolated use of TheraSuit and AdeliSuit without an associated intensive treatment protocol in the functioning of children with CP. The association of the suits with intensive protocols (e.g., TSM/AST) has increased expectations of good results in the rehabilitation of children and youth with CP.2,12,14,15 Among the selected studies, Bailes et al.,32 with better methodological quality, showed that there was no difference in the gross motor function and functional skills of children with CP when submitted to the TSM with or without the suit. The effects found might be due to the intensity of treatment and cannot be attributed to the isolated use of TheraSuit.32 In addition, Bar-Haim et al.33 and Mahani et al.34 revealed no difference between those interventions and other therapies when performed with the same intensity and duration. It is possible that the high intensity of training, instead of the specificity of the TSM and AST protocols, may be responsible for the improvements presented by the children submitted such interventions. This review corroborates a recent systematic review and meta-analysis13 that examined the effects of these therapies on the functioning of children with CP. The authors concluded that the available evidence was not sufficient to draw conclusions about the advantages and disadvantages of the TSM and AST in the treatment of gross motor function of children with CP.13

The DEFO and TheraTogs demonstrated positive effects24,25,28–30 on postural alignment and gait kinematics of children with diplegic CP. These individuals often present hip internal rotation and flexion, knee flexion, and tibia internal rotation, resulting in a gait pattern named “crouch gait”.37 Positive effects on the posture and gait of these children were previously documented with subjects wearing rigid orthoses.3,38 Hence, the association of rigid orthoses with a therapeutic suit (i.e., a dynamic orthoses) seems to potentiate the individual effects of each of these interventions in the diplegic children's gait kinematics.30 While rigid orthoses provide greater joint stability, dynamic orthoses have the potential to facilitate the execution of movements and their combination may perpetuate long-term positive changes in the musculoskeletal system of diplegic children.39,40

FBS, whose compressive characteristic aims to promote stability, did not demonstrate any improvements in gait stability when used in children with different CP types, even when the child was wearing the suit during the assessments.26,27 Additionally, Rennie et al.26 and Nicholson et al.27 have reported parents’ complaints concerning the discomfort associated with FBS, including changes in the urinary system and constipation, movement restrictions, warmth and eczema. These discomforts contributed to most children not enjoying the use of the suit and reporting they would not consider wearing it again.26,27 Knox41 followed a series of eight cases of children with CP who wore a suit with the same compressive characteristics for four weeks. Three children withdrew from participating in the study because they could not adapt to the suit. Those who completed the intervention stated that the suit was tight, hot, and difficult to put on and take off, with difficulties in using the toilet.41 The very low evidence of FBS's efficacy, in association with its adverse effects, result in a strong recommendation that it should not be used in the rehabilitation of children with CP.

The intensity and duration of therapeutic suit treatment varied greatly among the studies. Positive effects on body structure and function outcomes were found in situations of reduced intensity and duration25 (i.e., wearing DEFO for four to six hours/day for six weeks) as well as in situations of higher intensity28–30 and duration (i.e., wearing TheraTogs for 12h/day for 12 weeks). However, long-term effects were not systematically investigated. Only Flanagan et al.,30 investigated the isolated effects of TheraTogs, and found stable gains in gross motor skills in the follow-up period.30 Due to the differences among therapeutic suits and the time regimens in which they were implemented, the available evidence is not conclusive regarding the optimal intensity of suit wearing to guarantee their efficacy.

This systematic review has limitations that need to be considered. The criteria for selecting studies was met with a language restriction (only studies written in English, Portuguese or Spanish were included), resulting in the exclusion of seven potentially relevant studies published in Russian. Besides that, no literature searches were conducted in databases with no free access (e.g., EMBASE), which may have hindered the identification of potentially relevant studies. The Checklist for Measuring Study Quality presented difficulties regarding the interpretation and application of some items, especially those concerning external validity, which caused disagreements between the evaluators. These disagreements were minimized by discussion to reach a consensus. Finally, it was not possible to add a meta-analysis to this systematic review because the studies tested various therapeutic suit models in samples with different characteristics and compared different protocols.

The selected studies did not have sufficient information about (1) the direction and level of tension applied to the elastic elements in order to adjust the suits and (2) the exercises and activities conducted during the therapy sessions. Detailing the procedures is important since these elements constitute the mechanisms underlying therapeutic changes. Additionally, there is a lack of studies with a high level of evidence that identified the dose-response of this therapeutic resource (i.e., the sufficient and appropriate intensity and duration of suit wearing for the effects on different functional components). Finally, the studies lacked information about which children with CP (i.e., descriptive characteristics including age, topographic and severity) might be better candidates for obtaining the effects of different therapeutic suit models. Most studies that were part of this review included only children with mild to moderate severity of CP (GMFCS I–III) and with diplegic CP type, limiting the results for these subgroups.

The suits DEFO and TheraTogs seem to improve the postural alignment and gait performance in children with diplegic CP. However, the quality of current available evidence ranges from low to very low for the different suit models tested. The recommendation to use these suits in the treatment of children with CP is weak. Future studies that address the inconclusive elements indicated in this review may help to endorse or refute the effects of these dynamic orthoses and will most certainly affect the strength with which they can be recommended.

The authors declare no conflicts of interest.