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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
Catholic University, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Lycra, Motor Function, Static Balance

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept 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.

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

    First Posted
    March 9, 2016
    Last Updated
    March 16, 2016
    Sponsor
    Catholic University, Italy
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    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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