Robot Assisted Upper Limb Neuro-Rehabilitation

Phase 2

Completed

• Conditions: Acute Stroke

• Registration Number: NCT00011583
• Lead Sponsor: US Department of Veterans Affairs

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.

Study Timeline

• Study Start: 2000-01
• Study First Submitted: 2001-02-22
• Study First Submitted QC: 2001-02-23
• Study First Posted: 2001-02-26
• Primary Completion: 2003-12
• Study Completion: 2003-12
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-10
• Last Update Posted: 2008-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Stroke patients

Exclusion Criteria

Unable to follow instructions; medically unstable.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer score	end of training, 6-month follow-up

Trial Locations

Locations (1)

Central Texas Veterans Health Care System; 🇺🇸 Temple, Texas, United States