search
Back to results

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
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
February 6, 2009
Last Updated
January 9, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
search

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

Learn more about this trial

Light Constraint Induced Therapy Experiment

We'll reach out to this number within 24 hrs