Principal Investigators: Charles G. Burgar, MD and Peter S. Lum, PhD Project Staff: H.F. Machiel Van der Loos, PhD; Henry L. Lew, MD, PhD; AM Sherwood, PE, PhD (Houston VA); TN Monga, MD (Houston VA); AME Scremin, MD (W Los Angeles VA); and R Kumar, MD (W Los Angeles VA) Project Category: Stroke - 2001 Objective: This study continues our investigation of the optimal timing, intensity, and duration of robot-assisted training to improve motor performance in patients with hemiplegia following stroke. These hypotheses will be tested: 1) subjects receiving robot-assisted upper limb therapy with MIME in the initial (beginning 1-3 weeks post ictus) phase of recovery from stroke experience greater functional gains than a control group receiving additional conventional therapy of equal intensity and duration, 2) robot-assisted therapy results in a dose-dependent response, and 3) robot-assisted therapy promotes greater control of movement, greater recovery of strength, and greater reduction of co-contraction than the control intervention. Research Plan: A multi-site clinical trial will be conducted at the VA Houston Rehabilitation Research and Development Center of Excellence on Healthy Aging with Disabilities, the VA Greater Los Angeles Health Care System, and the VA Palo Alto Rehabilitation Research and Development Center of Excellence on Mobility. Palo Alto will serve as the coordinating site and will provide training and technical assistance for the other sites. One hundred two subjects with hemiparesis due to a unilateral single (first) stroke will be randomly assigned to 3 groups. Group 1 will receive 1 hour/day of robot-assisted upper limb therapy in addition to their usual physical and occupational therapy. Group 2 will receive a total of 2 hours/day of robot-assisted therapy. Group 3 will receive 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Outcome measures will include strength, motor control, functional, and patient satisfaction assessments at intake, discharge, 6 and 12 months. Two MIME robotic therapy systems are currently being fabricated for installation in Houston and Los Angeles. The addition of these locations to the VA robot-assisted neuro-rehabilitation program will facilitate enrollment of stroke subjects and allow evaluation of MIME outside its development environment. Expected Outcome: We believe earlier initiation of robot-assisted training will enhance neurological recovery, beyond that achieved with an equivalent amount of traditional therapy, by improving strength and decreasing abnormal co-contractions. We expect to observe a dose-dependent training effect. Funding Source: VA RR&D Merit Review Funding Status: Approved |
