Light Constraint Induced Therapy Experiment (LICITE)
|Stroke||Other: Light constraint induced therapy Other: Standard constraint induced therapy||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
|Official Title:||Effects of a Modified Constraint Induced Therapy Intervention in Stroke Patients: A Multicenter, Randomized Controlled Trial.|
- Motor activity log scale [ Time Frame: 10 days before inclusion, 10 days and 3 months after treatment achievement ]
- Wolf Motor Function test Stroke impact scale Functional MRI HAD scale [ Time Frame: 10 days before inclusion, 10 days and 3 months after treatment achievement except for fMRI (no evaluation at 3 month) ]
|Study Start Date:||February 2009|
|Study Completion Date:||June 2011|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
|Active Comparator: Modified Therapy||
Other: Light constraint induced therapy
90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation, 5 days/week/2 weeks.
Other Name: Modified constraint induced therapy
|Active Comparator: Standard Therapy||
Other: Standard constraint induced therapy
360 minutes of motor training with a physical or occupational therapist, 5 days/week/2 weeks
Other Name: Constraint induced therapy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839670
|Service de Médecine Physique et de Réadaptation - Hôpital BICHAT|
|Paris, Paris Cedex 18, France, 75877|
|Principal Investigator:||Olivier SIMON, MD, PhD||Assistance Publique - Hôpitaux de Paris|