Light Constraint Induced Therapy Experiment

Phase 3TerminatedNCT00839670

Assistance Publique - Hôpitaux de Paris34 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke

Interventions

Light constraint induced therapyOTHER

90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation, 5 days/week/2 weeks.

Standard constraint induced therapyOTHER

360 minutes of motor training with a physical or occupational therapist, 5 days/week/2 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Service de Médecine Physique et de Réadaptation - Hôpital BICHAT

Paris, Paris Cedex 18, France

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

Time frame: 10 days before inclusion, 10 days and 3 months after treatment achievement except for fMRI (no evaluation at 3 month)

Data from ClinicalTrials.gov

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