Robotic Upper-Limb Neurorehabilitation in Chronic Stroke Patient - Full Text View

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00037934

Purpose

We have established the feasibility and effectiveness of robot-aided rehabilitation in stroke patients using a robot for neurological rehabilitation designed and built by MIT. Results of a pilot study of 20 patients were promising and showed that robot therapy is safe, tolerated by patients and produces a significant, measurable benefit. We propose to test that the robotic upper extremity trainer is an acceptable cost effective adjunct to standard occupational therapy for patients with dysfunction of the shoulder and elbow due to hemiparetic stroke in a VA rehabilitation program.

Condition	Intervention	Phase
Stroke	Device: Upper extremity robot Other: Traditional Supervised Upper Extremity Exercises	Phase II

MedlinePlus related topics: Exercise and Physical Fitness Rehabilitation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Evaluation of Robotic Upper Extremity Neuro-Rehabilitation

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Upper limb Motor Status Score, Wolf Motor Function Test, Motor Power Assessment, and Fugl-Meyer Upper Extremity Motor Performance Test [ Time Frame: The Primary Outcome measures were performed at baseline, after completion of 18 sessions of intervention and at 3 months follow-up. ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	April 2002
Study Completion Date:	January 2005
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Robot exercise group	Device: Upper extremity robot Robotic upper extremity neuro-rehabilitation
2: Active Comparator Traditional exercise group	Device: Upper extremity robot Robotic upper extremity neuro-rehabilitation Other: Traditional Supervised Upper Extremity Exercises Arm ergometer, reaching, and stretching exercises

Eligibility

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

Criteria

Inclusion Criteria:

Chronic Stroke
Manual Muscle Score of Grade 3 or lower in at least one muscle of the affected arm

Exclusion Criteria:

Acute Stroke
Contracture or orthopedic problems limiting the movement of the affected arm
Visual deficit such that the participant cannot see the test pattern on the robot trainer
Serious complicating medical illness
Botox treatment to the involved arm within three months of enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037934

Locations

United States, Maryland
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Christopher Bever, MD

VA Maryland Health Care System, Baltimore

More Information

Responsible Party:	Department of Veterans Affairs ( Bever, Christopher - Principal Investigator )
Study ID Numbers:	B2436
Study First Received:	May 24, 2002
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00037934
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Robot
Stroke
Upper Extremity

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases

Central Nervous System Diseases
Brain Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009