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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02131909
Other study ID # 2013-A01325-40
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2014
Est. completion date November 2017

Study information

Verified date May 2023
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date November 2017
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 7 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
mirror therapy
During a session, the child performs a series of 10 single, bilateral and synchronous movements while viewing the reflected image
bimanual rehabilitation exercises
During a session, the child performs a series of 10 single, bilateral and synchronous movements while watching his two hands

Locations

Country Name City State
France CHU Rennes Rennes

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

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- — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of the AHA (Assisting Hand Assessment) score 5 weeks
Secondary 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) baseline, 5 weeks, 10 weeks
Secondary Measurement of the maximal grasp and pinch strength with a Baseline dynamometer baseline, 5 weeks, 10 weeks
Secondary Qualitative and quantitative measurement of movement by a kinematic analysis via an Optitrack system baseline, 5 weeks, 10 weeks
Secondary Measurement of the manual ability by Abilhand-kids questionnaire baseline, 5 weeks, 10 weeks
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