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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00011583 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Stroke |
Device: Robot-assisted therapy Device: Traditional therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Robot Assisted Upper Limb Neuro-Rehabilitation |
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2000 |
| Study Completion Date: | December 2003 |
| Primary Completion Date: | December 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
1 hour/day of mechanically-assisted upper limb therapy
|
Device: Robot-assisted therapy
1 hour/day of mechanically-assisted upper limb therapy
|
|
2: Active Comparator
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Stroke patients
Exclusion Criteria:
Unable to follow instructions; medically unstable.
Contacts and Locations| United States, Texas | |
| Central Texas Veterans Health Care System | |
| Temple, Texas, United States, 76504 | |
| Principal Investigator: | Charles Burgar, MD | Central Texas Veterans Health Care System |
More Information
| Responsible Party: | Department of Veterans Affairs ( Burgar, Charles - Principal Investigator ) |
| Study ID Numbers: | B2156 |
| Study First Received: | February 22, 2001 |
| Last Updated: | March 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00011583 History of Changes |
| Health Authority: | United States: Federal Government |
|
Cerebrovascular Hemiplegia Robotics |
|
Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases |
Cardiovascular Diseases Brain Diseases Cerebrovascular Disorders |
