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Robotic Upper-Limb Neurorehabilitation in Chronic Stroke Patient

This study has been completed.
Sponsor:
Collaborator:
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00037934
First received: May 24, 2002
Last updated: October 6, 2011
Last verified: October 2011
History of Changes
  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 2

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:

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 May 23, 2013