Light Constraint Induced Therapy Experiment

NCT00839670 | Terminated Phase 3

• 1 other identifier: P070161
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

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.

Outcome Measures

Primary Outcomes (1)

• Motor activity log scale

  10 days before inclusion, 10 days and 3 months after treatment achievement

Secondary Outcomes (1)

• 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)

Study Arms (2)

Modified Therapy

ACTIVE COMPARATOR

Other: Light constraint induced therapy

Standard Therapy

ACTIVE COMPARATOR

Other: Standard constraint induced therapy

Interventions

Light constraint induced therapy OTHER

90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation, 5 days/week/2 weeks.

Also known as: Modified constraint induced therapy

Modified Therapy

Standard constraint induced therapy OTHER

360 minutes of motor training with a physical or occupational therapist, 5 days/week/2 weeks

Also known as: Constraint induced therapy

Standard Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Major cognitive impairment
• Prior stroke
• Excessive fatigability
• Severe aphasia
• MAL score ≥ 2,5

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Médecine Physique et de Réadaptation - Hôpital BICHAT

Paris, Paris Cedex 18, 75877, France

Location

MeSH Terms

Conditions

Stroke; Hemorrhagic Stroke

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Olivier SIMON, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 9, 2009
• Study Start: February 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: June 1, 2011
• Last Updated: January 10, 2012

Record last verified: 2009-02

Locations

FR (1)