Effects of Lycra Suits in Children With Cerebral Palsy

Not Applicable

• Conditions: Cerebral Palsy

• Registration Number: NCT02712021
• Lead Sponsor: Catholic University, Italy

Brief Summary

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

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.

Study Timeline

• Status Verified: 2016-03
• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-16
• Last Update Submitted: 2016-03-16
• Study First Posted: 2016-03-17
• Last Update Posted: 2016-03-17
• Study Start: 2016-04
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline evaluation of static balance at 6 months	The children were assessed twice, at baseline and 6 months after, each child acting as his/her own control.	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline Gross Motor Function Classification System at 6 months	The children were assessed twice, at baseline and 6 months after, each child acting as his/her own control.	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.