Robotic Upper-Limb Neurorehabilitation in Chronic Stroke Patient

October 6, 2011 updated by: US Department of Veterans Affairs

Evaluation of Robotic Upper Extremity Neuro-Rehabilitation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
The Primary Outcome measures were performed at baseline, after completion of 18 sessions of intervention and at 3 months follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Collaborators

Massachusetts Institute of Technology

Investigators

  • Principal Investigator: Christopher Bever, MD, VA Maryland Health Care System, Baltimore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

May 24, 2002

First Submitted That Met QC Criteria

May 24, 2002

First Posted (Estimate)

May 27, 2002

Study Record Updates

Last Update Posted (Estimate)

October 7, 2011

Last Update Submitted That Met QC Criteria

October 6, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2436

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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