Light Constraint Induced Therapy Experiment (LICITE)

This study has been terminated.
(departure of the investigator coordinator into other country)
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00839670
First received: February 6, 2009
Last updated: January 9, 2012
Last verified: February 2009
  Purpose

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 Intervention Phase
Stroke
Other: Light constraint induced therapy
Other: Standard constraint induced therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effects of a Modified Constraint Induced Therapy Intervention in Stroke Patients: A Multicenter, Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Motor activity log scale [ Time Frame: 10 days before inclusion, 10 days and 3 months after treatment achievement ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 34
Study Start Date: February 2009
Study Completion Date: June 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839670

Locations
France
Service de Médecine Physique et de Réadaptation - Hôpital BICHAT
Paris, Paris Cedex 18, France, 75877
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Olivier SIMON, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00839670     History of Changes
Other Study ID Numbers: P070161
Study First Received: February 6, 2009
Last Updated: January 9, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
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:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 24, 2014