This research study will conduct a double-blind randomized clinical trial of an intensive motor-sensory rehabilitation on patients with acute stroke using a wearable rehabilitation robot. The primary aims are to facilitate sensorimotor recovery, reduce ankle impairments, and improve balance and gait functions. This clinical trial will be conducted on the study and control groups of acute stroke survivors.
The project will investigate an early treatment in acute stroke for motor relearning, reducing ankle passive and active impairments and improving balance and mobility/locomotion functions. This will be a double-blind randomized control clinical trial with the patients and therapists who assess outcomes blinded to the group assignment. The trial will be conducted on two groups of acute stroke survivors randomly allocated to receive (1) Intensive robot-aided feedback-aided motor relearning, stretching to reduce joint spasticity/stiffness and provide sensory stimulation, and robot-guided active movement training through engaging movement game playing with audiovisual and haptic feedback (Study group), or (2) Passive movement in the middle ROM and active movement training without robotic guidance/feedback (Control group), 5 sessions per week over about 3 weeks during patients' hospital stay in neurology and rehabilitation services. For the study group, the impaired joint will be stretched forcefully under intelligent control with the stretching slowing down with increasing resistance but not stopping until a specified peak resistance torque is reached. The joint will be then held at the extreme range of motion (ROM) to allow stress relaxation to occur. The stretching will also provide sensory stimulation and the patients will be asked to feel the stretching and track the joint position to facilitate sensory recovery. Following stretching, active movement training will be conducted by engaging patients in motivating video games by which the limb will undergo movement training under real-time audiovisual and haptic feedback. The participants will play the games beyond their current active range of motion with the robot providing assistance or play within the active ROM with the robot providing resistance to improve motor control. Both groups will use the wearable ankle rehabilitation robot and both groups will also receive standard of care in the hospital and rehabilitation service. Carry-over effects will be further evaluated one month after treatment ends.
Aim 1: To evaluate biomechanical and neuromuscular changes as defined by the passive and active ROMs, flexor-extensor muscle strength, joint stiffness, proprioception and reflex excitability and compare these measures between the two groups. The biomechanical and neuromuscular outcome measures will be obtained through blinded assessments and evaluated before and after training using the wearable rehabilitation robot.
Hypothesis 1: Robot-guided motor relearning, stretching and active movement training (study group) will improve the biomechanical and neuromuscular outcome measures more than those of the control group.
Aim 2: To evaluate the clinical outcome measures as defined by Fugl-Meyer score (lower extremity), modified Ashworth scale, Berg balance scale, 10 m walk test, 6 min walk test (6MWT), and Timed-Up-and-Go test, and to compare between the Study and Control groups.
Hypothesis 2: The study group will improve the clinical outcome measures (F-M, MAS, balance, and gait) more than the control group.
- IntelliStretch rehabilitation robot Device
Intervention Desc: A portable rehabilitation robot will be used to move the impaired joint back and forth and the subject is asked to relax during the movement. The subject will also be asked to move the joint back and forth with the robot. ARM 1: Kind: Experimental Label: Study group Description: Subject in study group receive real-time feedback-facilitated motor training, robot-controlled stretching, and active movement training. Robot-guided movement training will be used for the intervention in Study group. ARM 2: Kind: Experimental Label: Control group Description: Subjects in control group will receive robot-controlled movement of the target joint without strong stretching and do active movement training without robot guidance. Robot-aided movement will be used for the intervention in Control group.
- Allocation: Randomized
- Masking: Double Blind (Subject, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Fugl-Meyer Lower Extremity (FMLE) - Pre||Within 1 week prior to intervention||No|
|Primary||Fugl-Meyer Lower Extremity (FMLE) - Post||Within 1 week of the completion of intervention||No|
|Primary||Fugl-Meyer Lower Extremity (FMLE) - FU||one month after the intervention end||No|
|Secondary||Active Range of Motion (AROM) - Pre||Within 1 week prior to intervention||No|
|Secondary||Active Range of Motion (AROM) - Post||Within 1 week following intervention||No|
|Secondary||Active Range of Motion (AROM) - Follow-up||1 month after intervention end||No|
|Secondary||Strength (MVC) - Pre||Within 1 week prior to intervention||No|
|Secondary||Strength (MVC) - Post||Within 1 week following intervention||No|
|Secondary||Strength - Follow-Up||1 month after intervention end||No|
|Secondary||Passive Range of Motion (PROM) - Pre-||Within 1 week prior to intervention||No|
|Secondary||Passive Range of Motion (PROM) - Post||Within 1 week following intervention||No|
|Secondary||Passive Range of Motion (PROM) - Follow-up||1 month after intervention end||No|
|Secondary||Stiffness - Pre||Within 1 week prior to intervention||No|
|Secondary||Stiffness - Post||Within 1 week following intervention||No|
|Secondary||Stiffness - Follow-up||1 month after intervention end||No|