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Robot Assisted Upper Limb Neuro-Rehabilitation

Primary Purpose

Acute Stroke

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Robot-assisted therapy
Traditional therapy
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Stroke focused on measuring Cerebrovascular, Hemiplegia, Robotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Stroke patients Exclusion Criteria: Unable to follow instructions; medically unstable.

Sites / Locations

  • Central Texas Veterans Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

1 hour/day of mechanically-assisted upper limb therapy

1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot

Outcomes

Primary Outcome Measures

Fugl-Meyer score

Secondary Outcome Measures

Full Information

First Posted
February 22, 2001
Last Updated
March 10, 2008
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00011583
Brief Title
Robot Assisted Upper Limb Neuro-Rehabilitation
Official Title
Robot Assisted Upper Limb Neuro-Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
December 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
Cerebrovascular, Hemiplegia, Robotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
1 hour/day of mechanically-assisted upper limb therapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot
Intervention Type
Device
Intervention Name(s)
Robot-assisted therapy
Intervention Description
1 hour/day of mechanically-assisted upper limb therapy
Intervention Type
Device
Intervention Name(s)
Traditional therapy
Intervention Description
1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot
Primary Outcome Measure Information:
Title
Fugl-Meyer score
Time Frame
end of training, 6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stroke patients Exclusion Criteria: Unable to follow instructions; medically unstable.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Burgar, MD
Organizational Affiliation
Central Texas Veterans Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Texas Veterans Health Care System
City
Temple
State/Province
Texas
ZIP/Postal Code
76504
Country
United States

12. IPD Sharing Statement

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Robot Assisted Upper Limb Neuro-Rehabilitation

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