Effects of Lycra Suits in Children With Cerebral Palsy (CP)
Primary Purpose
Cerebral Palsy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lycra suit and physiotherapy treatment
physiotherapy treatment
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Lycra, Motor Function, Static Balance
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cerebral Palsy-Study group
Cerebral Palsy-Control Group
Arm 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.
Children with clinical characteristics similar to the study group; they will be assessed using the same protocol but with no use of lycra garments
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change from baseline Gross Motor Function Classification System at 6 months
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.
Full Information
NCT ID
NCT02712021
First Posted
March 9, 2016
Last Updated
March 16, 2016
Sponsor
Catholic University, Italy
1. Study Identification
Unique Protocol Identification Number
NCT02712021
Brief Title
Effects of Lycra Suits in Children With Cerebral Palsy
Acronym
CP
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University, Italy
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral Palsy, Lycra, Motor Function, Static Balance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cerebral Palsy-Study group
Arm Type
Experimental
Arm 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.
Arm Title
Cerebral Palsy-Control Group
Arm Type
Active Comparator
Arm 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
Intervention Type
Other
Intervention Name(s)
Lycra suit and physiotherapy treatment
Intervention Description
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
Intervention Name(s)
physiotherapy treatment
Intervention Description
All the children will be involved in regular physiotherapy treatment (2-3/week).
Primary Outcome Measure Information:
Title
Change from baseline evaluation of static balance at 6 months
Description
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.
Time Frame
The children were assessed twice, at baseline and 6 months after, each child acting as his/her own control.
Secondary Outcome Measure Information:
Title
Change from baseline Gross Motor Function Classification System at 6 months
Description
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.
Time Frame
The children were assessed twice, at baseline and 6 months after, each child acting as his/her own control.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Domenico Romeo, MD, PhD
Email
domenicomarco.romeo@policlinicogemalli.it
12. IPD Sharing Statement
Citations:
PubMed Identifier
16028646
Citation
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.
Results Reference
result
PubMed Identifier
19440130
Citation
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.
Results Reference
result
PubMed Identifier
19961295
Citation
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.
Results Reference
result
Learn more about this trial
Effects of Lycra Suits in Children With Cerebral Palsy
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