Light Constraint Induced Therapy Experiment

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Other: Light constraint induced therapy
* Other: Standard constraint induced therapy


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Age > 18 years First ischemic or hemorrhagic stroke between 2 and 12 months at least 10°of active wrist extension and at least 10° of thumb abduction/ extension, and at least 10° of extension in at least 2 additional digits. adequate balance while wearing the restraint EXCLUSION CRITERIA: Major cognitive impairment Prior stroke Excessive fatigability Severe aphasia MAL score ≥ 2,5 Specific exclusion criteria for fMRI ancillary study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Modified Therapy<br> | Other: Light constraint induced therapy<br>* 90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation, 5 days/week/2 weeks.<br>* Other names: Modified constraint induced therapy;|
| Active Comparator: Standard Therapy<br> | Other: Standard constraint induced therapy<br>* 360 minutes of motor training with a physical or occupational therapist, 5 days/week/2 weeks<br>* Other names: Constraint induced therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor activity log scale |  | 10 days before inclusion, 10 days and 3 months after treatment achievement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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1- Constraint induced therapy, 2- Stroke, 3- Upper limb, 4- Rehabilitation, 5- Motor training, 1- First time clinical ischemic or hemorrhagic stroke, 2- At least 10° of active wrist extension, 3- At least 10° of thumb abduction/ extension, 4- At least 10° of extension in at least 2 additional digits, 3- Adequate balance while wearing the restraint.