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Clinical Trials/NCT00839670
NCT00839670
Terminated
Phase 3

Effects of a Modified Constraint Induced Therapy Intervention in Stroke Patients: A Multicenter, Randomized Controlled Trial.

Assistance Publique - Hôpitaux de Paris1 site in 1 country34 target enrollmentFebruary 2009
ConditionsStroke

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Stroke
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
34
Locations
1
Primary Endpoint
Motor activity log scale
Status
Terminated
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
June 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Motor activity log scale

Time Frame: 10 days before inclusion, 10 days and 3 months after treatment achievement

Secondary Outcomes

  • 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))

Study Sites (1)

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