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

Sponsor:	Department of Veterans Affairs
Collaborator:	Massachusetts Institute of Technology
Information provided by (Responsible Party):	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Evaluation of Robotic Upper Extremity Neuro-Rehabilitation

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Rehabilitation

U.S. FDA Resources

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:	December 2004
Primary Completion Date:	September 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Robot exercise group	Device: Upper extremity robot Robotic upper extremity neuro-rehabilitation
Active Comparator: 2 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

Massachusetts Institute of Technology

Investigators

Principal Investigator:

Christopher Bever, MD

VA Maryland Health Care System, Baltimore

More Information

No publications provided

Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00037934 History of Changes
Other Study ID Numbers:	B2436
Study First Received:	May 24, 2002
Last Updated:	October 6, 2011
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Robot
Stroke
Upper Extremity

Additional relevant MeSH terms:

Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on February 09, 2012