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PC MIROIR : Effects of Mirror Therapy in Children With Hemiplegic Cerebral Palsy (PC MIROIR)

Primary Purpose

Hemiplegic Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
mirror therapy
bimanual rehabilitation exercises
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hemiplegic Cerebral Palsy focused on measuring unilateral cerebral palsy, children, upper-limb, mirror therapy, bimanual coordination, kinematics analysis

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Unilateral spastic cerebral palsy as defined by SCPE (Surveillance of Cerebral Palsy in Europe)
  • Aged 7 to 17 years
  • MACS (Manual Ability Classification System) 1 to 3
  • Extension of the wrist more than 10°
  • Free, informed and written consent of the parents
  • Free, informed and written consent of the child
  • affiliated, via his/her parents, to the Social Security regime

Exclusion Criteria:

  • Other neuromuscular disorders known
  • Cognitive impairment hampering the understanding of instructions
  • Upper-limb pain (EVA score >3)
  • Restriction of passive range of motion
  • Visual impairment not allowing the visualization of the upper limb in the mirror
  • Upper-limb Botulinum toxin injection in upper limb 6 months prior to inclusion

Sites / Locations

  • CHU Rennes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

mirror therapy

bimanual rehabilitation exercises

Arm Description

5 sessions mirror therapy 15 minutes per week for 5 weeks

5 sessions control therapy 15 minutes per week for 5 weeks

Outcomes

Primary Outcome Measures

Measurement of the AHA (Assisting Hand Assessment) score

Secondary Outcome Measures

Evolution of the AHA score
a variance analysis using 2 factors (time, group) is used (between the onset and 5 weeks later, between the onset and 10 weeks later)
Measurement of the maximal grasp and pinch strength
with a Baseline dynamometer
Qualitative and quantitative measurement of movement
by a kinematic analysis via an Optitrack system
Measurement of the manual ability
by Abilhand-kids questionnaire

Full Information

First Posted
April 28, 2014
Last Updated
May 22, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02131909
Brief Title
PC MIROIR : Effects of Mirror Therapy in Children With Hemiplegic Cerebral Palsy
Acronym
PC MIROIR
Official Title
PC MIROIR : Effects of Mirror Therapy in Children With Hemiplegic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized and comparative prospective test, monocentric and controlled (mirror therapy versus bimanual rehabilitation exercises), in single-blind (investigator and occupational therapist " 1 " do not know the type of rehabilitation performed).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Cerebral Palsy
Keywords
unilateral cerebral palsy, children, upper-limb, mirror therapy, bimanual coordination, kinematics analysis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mirror therapy
Arm Type
Experimental
Arm Description
5 sessions mirror therapy 15 minutes per week for 5 weeks
Arm Title
bimanual rehabilitation exercises
Arm Type
Placebo Comparator
Arm Description
5 sessions control therapy 15 minutes per week for 5 weeks
Intervention Type
Procedure
Intervention Name(s)
mirror therapy
Intervention Description
During a session, the child performs a series of 10 single, bilateral and synchronous movements while viewing the reflected image
Intervention Type
Procedure
Intervention Name(s)
bimanual rehabilitation exercises
Intervention Description
During a session, the child performs a series of 10 single, bilateral and synchronous movements while watching his two hands
Primary Outcome Measure Information:
Title
Measurement of the AHA (Assisting Hand Assessment) score
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Evolution of the AHA score
Description
a variance analysis using 2 factors (time, group) is used (between the onset and 5 weeks later, between the onset and 10 weeks later)
Time Frame
baseline, 5 weeks, 10 weeks
Title
Measurement of the maximal grasp and pinch strength
Description
with a Baseline dynamometer
Time Frame
baseline, 5 weeks, 10 weeks
Title
Qualitative and quantitative measurement of movement
Description
by a kinematic analysis via an Optitrack system
Time Frame
baseline, 5 weeks, 10 weeks
Title
Measurement of the manual ability
Description
by Abilhand-kids questionnaire
Time Frame
baseline, 5 weeks, 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unilateral spastic cerebral palsy as defined by SCPE (Surveillance of Cerebral Palsy in Europe) Aged 7 to 17 years MACS (Manual Ability Classification System) 1 to 3 Extension of the wrist more than 10° Free, informed and written consent of the parents Free, informed and written consent of the child affiliated, via his/her parents, to the Social Security regime Exclusion Criteria: Other neuromuscular disorders known Cognitive impairment hampering the understanding of instructions Upper-limb pain (EVA score >3) Restriction of passive range of motion Visual impairment not allowing the visualization of the upper limb in the mirror Upper-limb Botulinum toxin injection in upper limb 6 months prior to inclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène HR Rauscent
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Rennes
City
Rennes
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29701242
Citation
Gaillard F, Cretual A, Cordillet S, Le Cornec C, Gonthier C, Bouvier B, Heyman R, Marleix S, Bonan I, Rauscent H. Kinematic motion abnormalities and bimanual performance in children with unilateral cerebral palsy. Dev Med Child Neurol. 2018 Aug;60(8):839-845. doi: 10.1111/dmcn.13774. Epub 2018 Apr 27.
Results Reference
result

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PC MIROIR : Effects of Mirror Therapy in Children With Hemiplegic Cerebral Palsy

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