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

February 6, 2009
January 9, 2012
February 2009
November 2010   (final data collection date for primary outcome measure)
Motor activity log scale [ Time Frame: 10 days before inclusion, 10 days and 3 months after treatment achievement ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00839670 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Light Constraint Induced Therapy Experiment
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Stroke
  • 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
  • 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
  • Active Comparator: Modified Therapy
    Intervention: Other: Light constraint induced therapy
  • Active Comparator: Standard Therapy
    Intervention: Other: Standard constraint induced therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
34
June 2011
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00839670
P070161
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Olivier SIMON, MD, PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP