Effects of Lycra Suits in Children With Cerebral Palsy

Study Overview
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Brief Summary
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Lycra garments have recently been used for children with cerebral palsy, with favorable effects on alignment, biomechanics and neuromuscular activity. The aim of the present study is to determine the efficacy of a Lycra suit in improving motor function and static balance in children with cerebral palsy. The children included in this study will be part of a prospective project on children with cerebral palsy, older than 4 years of age, and their families regularly followed at the Child Neurology Unit of the Catholic University of Rome.

Detailed Description
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A total of 10 children with cerebral palsy will be recruited and included in the study. Five of them will be considered as study group and will wear a lycra suit, with shoulder, trunk and pelvis coverage, for more than 4 hours per day for 6 months. The other 5 will be considered as control group, matched for age and sex to the study group, and will not wear the lycra suit. The evaluation of static balance and the gross motor function measure will be used as outcome measure. The children of both groups will be assessed twice, at baseline and 6 months after, each child acting as his/her own control. The motor function assessments will be performed without the Lycra suit, whereas the static balance assessments were performed with and without the suit.

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Other: Lycra suit and physiotherapy treatment
* Other: physiotherapy treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of cerebral palsy based on the predominant type of motor impairment and classified according to the criteria proposed by Himmelmann. Exclusion Criteria: Presence of major congenital malformations or metabolic or haematological complications. The investigators will also exclude children who had previously worn a lycra garment and who received Botulinum toxin injections or orthopaedic surgery in the year before the study.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cerebral Palsy-Study group<br>The intervention consisted of wearing a lycra suit, with shoulder, trunk and pelvis coverage, for more than 4 hours per day for 6 months. The motor function assessments will be performed without the Lycra suit, whereas the static balance assessments were performed with and without the suit. | Other: Lycra suit and physiotherapy treatment<br>* Garments will be fitted by an occupational therapy with the treating therapist and child neurologist present. The garments will be constructed of Lycra with the possibility of adding reinforcing panels or derotation bands. All the children will be involved in regular physiotherapy treatment (2-3/week).<br>|
| Active Comparator: Cerebral Palsy-Control Group<br>Children with clinical characteristics similar to the study group; they will be assessed using the same protocol but with no use of lycra garments | Other: physiotherapy treatment<br>* All the children will be involved in regular physiotherapy treatment (2-3/week).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline evaluation of static balance at 6 months | The evaluation of static balance will be assessed by a seated stabilometry exam performed on a Prokin PK 254 P device produced by TecnoBody S.r.l. (Dalmine BG - Italy). This device consists of a static plate (47 centimeters of circumference) equipped internally with four piezoelectric sensors positioned at the extremity of the four cardinals points. | The children were assessed twice, at baseline and 6 months after, each child acting as his/her own control. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Gross Motor Function Classification System at 6 months | The Gross Motor Function Measure (GMFM) will be used to evaluate gross motor function quantitatively. The GMFM consists of 88 items grouped into 5 dimensions: A (lying and rolling), B (sitting), C (crawling and kneeling), D (standing), E (walking, running and jumping). Scores for each dimension are expressed as a percentage of the maximum score for that dimension. A total score is obtained by adding the scores for all dimensions and dividing by 5, ranging from 0 to 100. | The children were assessed twice, at baseline and 6 months after, each child acting as his/her own control. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Palsy, Lycra, Motor Function, Static Balance