Robot Assisted Upper Limb Neuro-Rehabilitation

March 10, 2008 updated by: US Department of Veterans Affairs

Our long term objectives are to understand the mechanisms of motor impairment following neurologic injury and to develop interventions to improve motor recovery. A series of complementary, overlapping clinical trials and development activities will validate and optimize the use of robot-assisted upper limb therapy for neuro rehabilitation.

We have developed a robotic system that assists or resists elbow and shoulder movements in three dimensional space. In addition to unilateral exercise modes, a novel bimanual mode enables hemiparetic subjects to practice mirror image upper limb exercises.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized controlled clinical trial of the Mirror Image Movement Enabler (MIME) robotic device for shoulder and elbow neurorehabilitation in subacute stroke patients. MIME incorporates a PUMA 560 robot that applies forces to the paretic limb during unilateral and bilateral movements in three dimensions. Robot-assisted treatment (bilateral, unilateral, and combined bilateral and unilateral) was compared with conventional therapy.

Study Type

Interventional

Enrollment (Anticipated)

60

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
    • Texas
      • Temple, Texas, United States, 76504
        • Central Texas Veterans Health Care System

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:

Stroke patients

Exclusion Criteria:

Unable to follow instructions; medically unstable.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
1 hour/day of mechanically-assisted upper limb therapy
Device: Robot-assisted therapy
1 hour/day of mechanically-assisted upper limb therapy
Active Comparator: 2
1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot
Device: Traditional therapy
1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fugl-Meyer score
Time Frame: end of training, 6-month follow-up
end of training, 6-month follow-up

Collaborators and Investigators

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

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Charles Burgar, MD, Central Texas Veterans Health Care System

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

January 1, 2000

Primary Completion (Actual)

December 1, 2003

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

February 22, 2001

First Submitted That Met QC Criteria

February 23, 2001

First Posted (Estimate)

February 26, 2001

Study Record Updates

Last Update Posted (Estimate)

March 11, 2008

Last Update Submitted That Met QC Criteria

March 10, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2156

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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