Light Constraint Induced Therapy Experiment

Phase 3

Terminated

• Conditions: Stroke
• Interventions: Other: Light constraint induced therapy; Other: Standard constraint induced therapy

• Registration Number: NCT00839670
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The purpose of this trial is to compare the effect of a modified constraint induced therapy to the treatment described originally by Taub et al.. This study will determine if LICITE will lead to similar improvements than the original described method.

Detailed Description

Constraint-Induced Movement therapy or CI therapy is a rehabilitation method, that has been shown in controlled studies to produce improvements of upper limb motor function in stroke patients. However, in the original method, 6 hours of daily training are requested, which is often impossible to apply in the majority of rehabilitation unit.

The aim of this trial is to compare the effect of a modified constraint induced therapy (90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation) to the treatment described originally by Taub et al. (360 minutes of motor training with a physical or occupational therapist).

Patients randomly received one of the two treatment and be evaluated pre- post- and 3 months after the intervention ended. The treatment will last two weeks, five days per week. The evaluations will include clinical measure of motor function and functional MRI of the brain. The brain activity will be measure just before and after the intervention with a manual motor task in order to asses brain plasticity.

Study Timeline

• Status Verified: 2009-02
• Study Start: 2009-02
• Study First Submitted: 2009-02-06
• Study First Submitted QC: 2009-02-06
• Study First Posted: 2009-02-09
• Primary Completion: 2010-11
• Study Completion: 2011-06
• Last Update Submitted: 2012-01-09
• Last Update Posted: 2012-01-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Therapy	Light constraint induced therapy	-
Standard Therapy	Standard constraint induced therapy	-

Primary Outcome Measures

Name	Time	Method
Motor activity log scale	10 days before inclusion, 10 days and 3 months after treatment achievement

Secondary Outcome Measures

Name	Time	Method
Wolf Motor Function test Stroke impact scale Functional MRI HAD scale	10 days before inclusion, 10 days and 3 months after treatment achievement except for fMRI (no evaluation at 3 month)

Trial Locations

Locations (1)

Service de Médecine Physique et de Réadaptation - Hôpital BICHAT; 🇫🇷 Paris, Paris Cedex 18, France