LICITE: Light Constraint Induced Therapy Experiment

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Terminated

CT.gov ID

NCT00839670

Collaborator

(none)

Enrollment

Location

Arms

27.9

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: Light constraint induced therapy Other: Standard constraint induced therapy	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

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.

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Constraint induced therapy

Arm

Intervention/Treatment

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 Names:

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 Names:

Constraint induced therapy

Outcome Measures

Primary Outcome Measures

Motor activity log scale [10 days before inclusion, 10 days and 3 months after treatment achievement]

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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