NCT02712021

Effects of Lycra Suits in Children With Cerebral Palsy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Catholic University, Italy · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
OTHER	Lycra suit and physiotherapy treatment	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).
OTHER	physiotherapy treatment	All the children will be involved in regular physiotherapy treatment (2-3/week).

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-06-01
• Completion: 2016-12-01
• First posted: 2016-03-17
• Last updated: 2016-03-17