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

May 22, 2023 updated by: Rennes University Hospital
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

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.

Study Locations

  • France
      • Rennes, France
        • CHU Rennes

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

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mirror therapy
5 sessions mirror therapy 15 minutes per week for 5 weeks
Procedure: mirror therapy
During a session, the child performs a series of 10 single, bilateral and synchronous movements while viewing the reflected image
Placebo Comparator: bimanual rehabilitation exercises
5 sessions control therapy 15 minutes per week for 5 weeks
Procedure: bimanual rehabilitation exercises
During a session, the child performs a series of 10 single, bilateral and synchronous movements while watching his two hands

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of the AHA (Assisting Hand Assessment) score
Time Frame: 5 weeks
5 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Hélène HR Rauscent, CHU Rennes

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

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 (Actual)

February 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

May 5, 2014

First Posted (Estimate)

May 6, 2014

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A01325-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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