Light Constraint Induced Therapy Experiment "LICITE"

Terminated

Phase 3 Results N/A

Trial Description

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.

Trial Stopped: departure of the investigator coordinator into other country

Conditions

Interventions

  • Light constraint induced therapy Other
    Other Names: Modified constraint induced therapy
    Intervention Desc: 90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation, 5 days/week/2 weeks.
    ARM 1: Kind: Experimental
    Label: Modified Therapy
  • Standard constraint induced therapy Other
    Other Names: Constraint induced therapy
    Intervention Desc: 360 minutes of motor training with a physical or occupational therapist, 5 days/week/2 weeks
    ARM 1: Kind: Experimental
    Label: Standard Therapy

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Investigator)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Motor activity log scale 10 days before inclusion, 10 days and 3 months after treatment achievement No
Secondary 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) Yes

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