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Automated Constraint-Induced Therapy for Restoring Movement After Stroke
This study has been completed.
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00037960
  Purpose

We propose to develop and evaluate a workstation that significantly enhances the application of Constraint-Induced (CI) Therapy by automating and instrumenting several of the tasks currently used in the shaping training. The motivation for development of such a device is as follows: 1) Patients could receive CI therapy at home without the need for constant supervision from a therapist. Many veterans do not have the resources to travel to their local VAMC for the two or three week period required for the treatment. A home-based device would expand the pool of veterans who could receive CI therapy. 2) For subjects who were able to receive CI therapy in the clinic, this device would facilitate an effective post-treatment home-practice program. 3) Currently, patients are treated on a one-on-one basis in the clinic. This device could allow one therapist to treat 3 or 4 patients at one time, thereby substantially reducing the cost of the therapy. 4) This workstation would provide clear and comprehensive quantification of the progress of the treatment. This could indicate on which tasks the patient was progressing most and least rapidly, and would therefore enable effective modifications of the treatment plan while treatment was in progress.

The hypothesis is that the positive outcomes of CI therapy can be achieved, and possibly enhanced, if the shaping training component is performed in a workstation that guides, motivates and records exercise of the more-affected limb. In the first 18 months, the workstation will be designed and fabricated. To expedite the design, we will rely on simple modifications to "off the shelf" components. In the last 18 months, a controlled, randomized, clinical trial will compare the effectiveness of automated CI therapy programs with standard CI therapy. The standard CI therapy group would receive shaping training in a clinical setting, one-on-one with a therapist. The clinic-based automated CI therapy group would perform the shaping training in the workstation, in a clinical setting and with minimal supervision. The home-based automated CI therapy group would perform the shaping training at home in the workstation, and with no direct supervision. All other aspects of the three treatment programs will be identical. At the end of this 3-year project, a device will have been designed, built and evaluated that could significantly enhance the application of CI therapy for chronic stroke patients.


Condition Intervention Phase
Cerebrovascular Accident
Procedure: Constrained Induced Therapy
Phase II

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: Automated Constraint-Induced Therapy for Restoring Movement After Stroke

Further study details as provided by Department of Veterans Affairs:

Study Start Date: June 2001
Study Completion Date: June 2004
Detailed Description:

Cerebrovascular accident (CVA) is the leading cause of disability in the United States. CVAs are a particular problem for the VA because of the large population of World War II and Korean War veterans who are now in the age range where CVAs are most frequent; in fiscal year 1997 the national VA system had 22,000 admissions for an acute CVA. The consequent motor deficits that veterans sustain result in very large costs to the VA and the Federal Government. The reduction of CVA-related disability thus represents a high VA and national health care priority.

Constraint-Induced (CI) therapy is one of the few techniques that has been proven with controlled, randomized studies to substantially reduce the incapacitating motor deficit of the more-affected upper extremity of patients with mild to moderately severe chronic strokes. The procedures of CI therapy are relatively simple and are deemed effective because they produce transfer of increased extremity use to the activities of daily living in the real world environment. The therapy involves promoting use of the more-affected upper extremity for 90% of waking hours by constraining the less-affected extremity for two or three consecutive weeks with a resting hand splint and sling or other device which prevents movement of the hand and wrist for activities of daily living. The patients receive a type of training termed "shaping" for 7 hours/day (with rest intervals) for all weekdays during this period (massed practice).

We propose to develop and evaluate a workstation that significantly enhances the application of CI therapy by automating and instrumenting several of the tasks currently used in the shaping training. The motivation for development of such a device is as follows: 1) Patients could receive CI therapy at home without the need for constant supervision from a therapist. Many veterans do not have the resources to travel to their local VAMC for the two or three week period required for the treatment. A home-based device would expand the pool of veterans who could receive CI therapy. 2) For subjects who were able to receive CI therapy in the clinic, this device would facilitate an effective post-treatment home-practice program. 3) Currently, patients are treated on a one-on-one basis in the clinic. This device could allow one therapist to treat 3 or 4 patients at one time, thereby substantially reducing the cost of the therapy. 4) This workstation would provide clear and comprehensive quantification of the progress of the treatment. This could indicate on which tasks the patient was progressing most and least rapidly, and would therefore enable effective modifications of the treatment plan while treatment was in progress.

The hypothesis is that the positive outcomes of CI therapy can be achieved, and possibly enhanced, if the shaping training component is performed in a workstation that guides, motivates and records exercise of the more-affected limb. In the first 18 months, the workstation will be designed and fabricated. To expedite the design, we will rely on simple modifications to "off the shelf" components. In the last 18 months, a controlled, randomized, clinical trial will compare the effectiveness of automated CI therapy programs with standard CI therapy. The standard CI therapy group would receive shaping training in a clinical setting, one-on-one with a therapist. The clinic-based automated CI therapy group would perform the shaping training in the workstation, in a clinical setting and with minimal supervision. The home-based automated CI therapy group would perform the shaping training at home in the workstation, and with no direct supervision. All other aspects of the three treatment programs will be identical. At the end of this 3-year project, a device will have been designed, built and evaluated that could significantly enhance the application of CI therapy for chronic stroke patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Stroke patients

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00037960

Locations
United States, California
VA Medical Center
Palo Alto, California, United States
Sponsors and Collaborators
Investigators
Investigator: David Wolff, Ph.D. Special Assistant to the Director Program Analysis and Review Section (PARS), VA Rehabilitation Research & Development Service
Investigator: Danielle Kerkovitch, Ph.D. Program Analysis and Review Section (PARS), VA Rehabilitation Research and Development Service
Investigator: Edward Taub, Ph.D. University of Alabama at Birmingham
  More Information

Study ID Numbers: B2480T
Study First Received: May 24, 2002
Last Updated: December 11, 2007
ClinicalTrials.gov Identifier: NCT00037960  
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Constrained Induced
CI therapy
CVA
Strokes

Study placed in the following topic categories:
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Brain Ischemia
Ischemia
Brain Infarction
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009