Effects of Lycra Suits in Children With Cerebral Palsy

NCT02712021 | Unknown

• 1 other identifier: 27711/14
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Lycra; Motor Function; Static Balance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Cerebral Palsy-Study group

EXPERIMENTAL

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

Cerebral Palsy-Control Group

ACTIVE COMPARATOR

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

Interventions

Lycra suit and physiotherapy treatment 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-Study group

physiotherapy treatment OTHER

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

Cerebral Palsy-Control Group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Confirmed diagnosis of cerebral palsy based on the predominant type of motor impairment and classified according to the criteria proposed by Himmelmann.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catholic University, Italy: lead

Related Publications (3)

• 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.

  PMID: 16028646 RESULT

• 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.

  PMID: 19440130 RESULT

• 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.

  PMID: 19961295 RESULT

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Domenico Romeo, MD, PhD

CONTACT

domenicomarco.romeo@policlinicogemalli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 17, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 17, 2016

Record last verified: 2016-03