Effects of Lycra Suits in Children With Cerebral Palsy (CP)

Catholic University, Italy

Status: Unknown

Conditions: Cerebral Palsy

Treatments: Other: Lycra suit and physiotherapy treatment; Other: physiotherapy treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02712021

27711/14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Cerebral Palsy-Study group

Experimental group

Description:

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.

Treatment:

Other: Lycra suit and physiotherapy treatment

Cerebral Palsy-Control Group

Active Comparator group

Description:

Children with clinical characteristics similar to the study group; they will be assessed using the same protocol but with no use of lycra garments

Treatment:

Other: physiotherapy treatment