Light Constraint Induced Therapy Experiment (LICITE)
Primary Purpose
Stroke
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Light constraint induced therapy
Standard constraint induced therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring 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.
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
Sites / Locations
- Service de Médecine Physique et de Réadaptation - Hôpital BICHAT
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Modified Therapy
Standard Therapy
Arm Description
Outcomes
Primary Outcome Measures
Motor activity log scale
Secondary Outcome Measures
Wolf Motor Function test Stroke impact scale Functional MRI HAD scale
Full Information
NCT ID
NCT00839670
First Posted
February 6, 2009
Last Updated
January 9, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00839670
Brief Title
Light Constraint Induced Therapy Experiment
Acronym
LICITE
Official Title
Effects of a Modified Constraint Induced Therapy Intervention in Stroke Patients: A Multicenter, Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Terminated
Why Stopped
departure of the investigator coordinator into other country
Study Start Date
February 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified Therapy
Arm Type
Active Comparator
Arm Title
Standard Therapy
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Light constraint induced therapy
Other Intervention Name(s)
Modified constraint induced therapy
Intervention Description
90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation, 5 days/week/2 weeks.
Intervention Type
Other
Intervention Name(s)
Standard constraint induced therapy
Other Intervention Name(s)
Constraint induced therapy
Intervention Description
360 minutes of motor training with a physical or occupational therapist, 5 days/week/2 weeks
Primary Outcome Measure Information:
Title
Motor activity log scale
Time Frame
10 days before inclusion, 10 days and 3 months after treatment achievement
Secondary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier SIMON, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Médecine Physique et de Réadaptation - Hôpital BICHAT
City
Paris
State/Province
Paris Cedex 18
ZIP/Postal Code
75877
Country
France
12. IPD Sharing Statement
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Light Constraint Induced Therapy Experiment
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