Efficacy of Unilateral Versus Bilateral Approach to Robot-Assisted Rehabilitation on Motor Control/Performance, Daily Functions, and Physiological Responses in Patients with Subacute Stroke

The purposes of this randomized controlled trial are to examine whether (1) the effects of unilateral (the InMotion3) and bilateral (the Bi-Manu-Track) robot-assisted training would differ in motor impairment/performance and daily functions in patients with subacute stroke; (2) the benefits on motor impairment/performance and daily functions, if any, could persist for six months after intervention; and (3) unilateral and bilateral robot-assisted training could result in different movement reorganization as well as changes in physiological markers of inflammation, oxidative stress, erythrocyte deformability, and blood glucose. We would also explore the possible differential treatment effects in patients with different levels of motor severity (i.e., moderate vs. severe). Studies have demonstrated that task-specific activities and high repetition/intensity are the critical training components for an effective upper extremity (UE) intervention such as robot-assisted training. There is evidence showing that robotic therapy can result in positive immediate and long-term effects on motor control, motor impairment/function, and daily function, depending on the severity of stroke. Nevertheless, there is no research on the differential effects of unilateral and bilateral robotic devices on motor and functional outcomes. The possible mechanisms underlying movement reorganization and physiological changes after different robot-assisted trainings need to be explored. Kinematic analysis is a sensitive tool for monitoring the effects on movement reorganization. Finally, brain damage is associated with the increased level of inflammation and oxidative stress (i.e., physiological markers) and may cause changes in the hemorhelogical blood profile. Those markers and erythrocyte deformability might be used to monitor the changes after robot-assisted trainings. At least 84 participants with subacute stroke will be recruited and randomly assigned to one of three treatment groups: unilateral robot, bilateral robot, and control intervention groups. All the intervention will be implemented 90 minutes/day, 5 days/week, for 4 weeks. All patients will receive 5 minutes of therapy to normalize muscle tone on the arm at the beginning of therapy. The two robot-assisted training groups will receive 70 minutes of robot-assisted training, followed by 15 minutes of functional task practice. The control intervention group will receive 90-minute conventional therapy (including 5 minutes of muscle tone normalization). Motor impairment/performance measures will include the UE part of Fugl-Meyer Assessment (FMA), Modified Ashworth Scale (MAS), MyotonPRO, Medical Research Council scale, Jamar dynamometer, and Action Research Arm Test (ARAT). Daily function measures will include Motor Activity Log (MAL), ABILHAND Questionnaire, accelerometers, and the Adelaide Activities Profile (AAP). Movement reorganization will be assessed by kinematic variables using upper-limb reaching tasks. Physiological markers consist of inflammation-related markers, oxidative stress markers, erythrocyte deformability, and blodd glucose. All the evaluations will be administered before and after intervention. Participants will be further re-evaluated on measures of motor impairment/performance and daily function at 6-month follow-up to assess the long-term effects. This comparative efficacy study is the first to compare the immediate effects of the InMotion3 and the Bi-Manu-Track and will contribute to determine if one training protocol is better than another. This research will also shed light on specific patterns of response to treatment for specific types of patients. Follow-up assessments will be used to study the long-term effects of different treatment protocols in robot-assisted trainings. Moreover, the results of the movement reorganization and physiological markers can add insight into the possible mechanisms of change to advance translational research in stroke rehabilitation. Finally, the analyses of treatment effects for patients with various degrees of impairments may identify the subgroups of stroke patients who are better responders to robot-assisted training.

Project ID:PC10301-0139
External Project ID:NSC102-2628-B182-005-MY3