Effects of Lycra Suits in Children With Cerebral Palsy (CP)
March 16, 2016 updated by: Domenico Romeo, Catholic University, Italy
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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).
|
|
Active Comparator: 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
|
All the children will be involved in regular physiotherapy treatment (2-3/week).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline evaluation of static balance at 6 months
Time Frame: 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.
|
The children were assessed twice, at baseline and 6 months after, each child acting as his/her own control.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline Gross Motor Function Classification System at 6 months
Time Frame: 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.
|
The children were assessed twice, at baseline and 6 months after, each child acting as his/her own control.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (Anticipated)
June 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
March 9, 2016
First Submitted That Met QC Criteria
March 16, 2016
First Posted (Estimate)
March 17, 2016
Study Record Updates
Last Update Posted (Estimate)
March 17, 2016
Last Update Submitted That Met QC Criteria
March 16, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27711/14
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