Clinical trial NCT00839670: Light Constraint Induced Therapy Experiment
Official title: Effects of a Modified Constraint Induced Therapy Intervention in Stroke Patients: A Multicenter, Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Stroke
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.
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-02-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Motor activity log scale
timeFrame: 10 days before inclusion, 10 days and 3 months after treatment achievement
Secondary outcomes:
measure: Wolf Motor Function test Stroke impact scale Functional MRI HAD scale
timeFrame: 10 days before inclusion, 10 days and 3 months after treatment achievement except for fMRI (no evaluation at 3 month)
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Médecine Physique et de Réadaptation - Hôpital BICHAT
state: Paris Cedex 18
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Olivier SIMON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: