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Robotic Upper-Limb Neurorehabilitation in Chronic Stroke Patient

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ClinicalTrials.gov Identifier: NCT00037934
Recruitment Status : Completed
First Posted : May 27, 2002
Last Update Posted : October 7, 2011
Sponsor:
Collaborator:
Massachusetts Institute of Technology
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment Phase
Stroke Device: Upper extremity robot Other: Traditional Supervised Upper Extremity Exercises Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Robotic Upper Extremity Neuro-Rehabilitation
Study Start Date : April 2002
Primary Completion Date : September 2004
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00037934


Locations
United States, Maryland
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
VA Office of Research and Development
Massachusetts Institute of Technology
Investigators
Principal Investigator: Christopher Bever, MD VA Maryland Health Care System, Baltimore

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00037934     History of Changes
Other Study ID Numbers: B2436
First Posted: May 27, 2002    Key Record Dates
Last Update Posted: October 7, 2011
Last Verified: October 2011

Keywords provided by VA Office of Research and Development:
Robot
Stroke
Upper Extremity

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases