Effects of Lycra Suits in Children With Cerebral Palsy

NCT ID: NCT02712021

Last Updated: 2016-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-12-31

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cerebral Palsy-Study group

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.

Group Type: EXPERIMENTAL

Lycra suit and physiotherapy treatment

Intervention Type: OTHER

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).

Cerebral Palsy-Control Group

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

Group Type: ACTIVE_COMPARATOR

physiotherapy treatment

Intervention Type: OTHER

All the children will be involved in regular physiotherapy treatment (2-3/week).

Interventions

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).

Intervention Type: OTHER

physiotherapy treatment

All the children will be involved in regular physiotherapy treatment (2-3/week).

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catholic University, Italy

OTHER

Sponsor Role: lead

Responsible Party

Domenico Romeo

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Domenico Romeo, MD, PhD

Role: CONTACT

domenicomarco.romeo@policlinicogemalli.it

References

Himmelmann K, Hagberg G, Beckung E, Hagberg B, Uvebrant P. The changing panorama of cerebral palsy in Sweden. IX. Prevalence and origin in the birth-year period 1995-1998. Acta Paediatr. 2005 Mar;94(3):287-94. doi: 10.1111/j.1651-2227.2005.tb03071.x.

Reference Type: RESULT

PMID: 16028646 (View on PubMed)

Flanagan A, Krzak J, Peer M, Johnson P, Urban M. Evaluation of short-term intensive orthotic garment use in children who have cerebral palsy. Pediatr Phys Ther. 2009 Summer;21(2):201-4. doi: 10.1097/PEP.0b013e3181a347ab.

Reference Type: RESULT

PMID: 19440130 (View on PubMed)

Matthews MJ, Watson M, Richardson B. Effects of dynamic elastomeric fabric orthoses on children with cerebral palsy. Prosthet Orthot Int. 2009 Dec;33(4):339-47. doi: 10.3109/03093640903150287.

Reference Type: RESULT

PMID: 19961295 (View on PubMed)

Other Identifiers

27711/14

Identifier Type: -

Identifier Source: org_study_id