Principal Investigators: Charles G. Burgar, MD and Peter S. Lum, PhD Project Staff: Machiel Van der Loos, PhD Project Category: Stroke Objective: This clinical trial will validate and help optimize the use of robot-assisted upper limb therapy for neuro-rehabilitation of subacute stroke survivors. Research Plan: With VA RR&D support, we have developed a robotic system (MIME) 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. In this clinical trial with subacute subjects, we will begin to identify the essential features of the robot therapy. A total of 100 subjects in the subacute phase of recovery from stroke will be recruited. Following stratification, subjects will be randomly assigned to four groups. One test group will receive treatment sessions incorporating both bimanual and unilateral robot modes. A 2nd test group will receive only unilateral robot treatment modes. A 3rd test group will receive only bimanual mirror-image exercise and none of the unilateral robot modes. The control group will receive conventional therapeutic exercise for upper limb function. A battery of clinical and biomechanical measures will be taken pre-treatment, immediately post-treatment, 6 months post-treatment and 1 year post-treatment. Work Accomplished: Modifications to the robotic system have been completed. These modifications include providing improved feedback of paretic limb performance to the subject during the training. The layout of the room has been modified to allow easier access to wheelchairs and to allow a single operator to run all the test sessions. Project staff have been trained in the clinical and biomechanical evaluations to be used in the clinical trial. The clinical evaluations have been expanded to include the Chedoke-McMaster Scale, Motor Power Exam, Motor Status Exam, Canadian Stroke Scale, NIH Stroke Scale, and the Stoke Impact Scale. The biomechanical measures have been modified to incorporate 3-dimensional motion analysis of upper-limb reaching movements with 8 channels of EMG, assessment of isometric and isokinetic strength at the elbow and shoulder using a Biodex Dynamometer, and measurement of elbow trajectory tracking ability. Subject enrollment and training is ongoing. Data analysis will occur during the terminal 6 months of the study. Expected Outcome: We believe the bimanual and unilateral exercise modes complement each other in promoting neurological recovery, with the unilateral exercise promoting strength increases and the bimanual exercise decreasing abnormal co-contractions. Funding Source: VA Merit Review Funding Status: Funded |
