The study will research early rehabilitation stroke for motor relearning, reducing ankle impairments and improving balance and mobility. The stroke patient will be randomly placed into two groups. Subjects in the study group will receive robot-aided motor relearning device under real-time feedback, stretching under intelligent control, sensory stimulation, and active movement training with interactive games. Subjects in the control group will receive passive movement without intelligent stretching and active movement training or robotic guidance. For both groups, the therapeutic training will be conducted during 5 hourly sessions each week over the course of 3 weeks. Both groups will also receive standard care in the hospital and rehabilitation services. Treatment outcome measures will be obtained through blinded assessments and evaluated before and after training. The treatment also involves biomechanical, neuromuscular and clinical outcome measures. Residual effects will be further evaluated 1 month after the treatment ends.
This is an interventional, randomized, single blind, parallel assignment with the primary purpose of treatment. There is an estimated 140 participants. The study began on April 26, 2019 and is estimated to be completed by October 2020.
- First time unilateral acute stroke, hemorrhagic or ischemic, 24 hours after admission in hospital to 1 month post stroke.
- Hemiplegia or hemiparesis
- All sexes, ages 18-80 years old
- Ankle impairments
- No impairment or very mild ankle impairment of ankle
- Unstable medical conditions that interferes with ability to training and exercise
- Severe cardiovascular disorders that interfere with ability to perform moderate movement exercises
- Cognitive impairment or aphasia with inability to follow instructions
- Pressure ulcer, recent surgical incision, or active skin disease with open wounds present below knee of treated limb
- Severe pain in legs
You may participate in this study at the University of Maryland, Baltimore in Baltimore, Maryland, United States, 21201. If you have any questions or concerns you may contact Chunyang Zhang, M.D. at 410-706-8625 or at ChunyangZhang@som.umaryland.edu.
This study is sponsored by the University of Maryland and collaborated by Northwestern University and Northwestern Memorial Hospital. Li-Qun Zhang, Ph.D of the University of Maryland is the Principal Investigator.
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