Light Constraint Induced Therapy Experiment (LICITE)

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

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.

Study Overview

• Status: Terminated
• Conditions: Stroke
• Intervention / Treatment: Other: Light constraint induced therapy; Other: Standard constraint induced therapy

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris Cedex 18
    • Paris, Paris Cedex 18, France, 75877
      • Service de Médecine Physique et de Réadaptation - Hôpital BICHAT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Olivier SIMON, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: February 6, 2009
• First Submitted That Met QC Criteria: February 6, 2009
• First Posted (Estimate): February 9, 2009

Study Record Updates

• Last Update Posted (Estimate): January 10, 2012
• Last Update Submitted That Met QC Criteria: January 9, 2012
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: 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.
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: P070161