Light Constraint Induced Therapy Experiment

Stroke Clinical Trial

— LICITE  

Official title:

Effects of a Modified Constraint Induced Therapy Intervention in Stroke Patients: A Multicenter, Randomized Controlled Trial.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00839670
• Other study ID #: P070161
• Status: Terminated
• Phase: Phase 3
• First received: February 6, 2009
• Last updated: January 9, 2012
• Start date: February 2009
• Est. completion date: June 2011

Study information

• Verified date: February 2009
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: June 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• Standard constraint induced therapy
360 minutes of motor training with a physical or occupational therapist, 5 days/week/2 weeks

Locations

Country	Name	City	State
France	Service de Médecine Physique et de Réadaptation - Hôpital BICHAT	Paris	Paris Cedex 18

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor activity log scale		10 days before inclusion, 10 days and 3 months after treatment achievement	No
Secondary	Wolf Motor Function test Stroke impact scale Functional MRI HAD scale		10 days before inclusion, 10 days and 3 months after treatment achievement except for fMRI (no evaluation at 3 month)	Yes