Facilitating Neuroplastic Changes of Acute Stroke Survivors With Severe Hemiplegia
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- University of Maryland, Baltimore
- Enrollment
- 68
- Locations
- 2
- Primary Endpoint
- Fugl-Meyer Lower Extremity (FMLE)
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
This project will develop a wearable rehabilitation robot suitable for in-bed acute stage rehabilitation. It involves robot-guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output. The early acute stroke rehabilitation device will be evaluated in this clinical trial.
Detailed Description
Stroke survivors often experience loss of motor control and impaired function. Immediately after stroke, there is a time-limited window of heightened plasticity during which the greatest gains in recovery occur. Therefore, early intensive sensorimotor rehabilitation post-stroke is critical in improving functional outcomes and minimizing disability. However, acute stroke survivors often receive little active training to improve mobility during their hospital stay and they are left alone during most of the day. Especially for those acute patients with no voluntary motor output, active motor training might be even less, partly due to a lack of rehabilitation protocols to detect potential motor recovering signals sensitively and facilitate neuroplastic changes. To address this unmet clinical need, this project will develop a novel wearable rehabilitation robot suitable for in-bed acute stage rehabilitation with guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output. The early acute stroke rehabilitation device will be evaluated in this clinical trial.
Investigators
Li-Qun Zhang
Professor
University of Maryland, Baltimore
Eligibility Criteria
Inclusion Criteria
- •Acute first time unilateral hemispheric stroke (hemorrhagic or ischemic stroke, 24 hours after admission to 1 month post-stroke at the start of the proposed treatment)
- •Hemiplegia or hemiparesis
- •0≤Manual Muscle Testing (MMT)\<=2
- •Age 30-85
- •Ankle impairments including stiff calf muscles and/or inadequate dorsiflexion
Exclusion Criteria
- •Medically not stable
- •Associated acute medical illness that interferes with ability to training and exercise
- •No impairment or very mild ankle impairment of ankle
- •Severe cardiovascular problems that interfere with ability to perform moderate movement exercises
- •Cognitive impairment or aphasia with inability to follow instructions
- •Severe pain in legs
- •Severe ankle contracture greater than 15° plantar flexion (when pushing ankle to dorsiflexion)
- •Pressure ulcer, recent surgical incision or active skin disease with open wounds present below knee
Outcomes
Primary Outcomes
Fugl-Meyer Lower Extremity (FMLE)
Time Frame: At the beginning and end of 3-week training, and 1 month after the treatment ends]
The Fugl-Meyer Lower Extremity (FMLE) assessment is a measure of lower extremity (LE) motor and sensory impairments. The FMLE scale ranges from 0 to 34, with higher scores indicating better motor function.
Secondary Outcomes
- Passive Range of Motion (PROM) will be measured in degrees in the ankle joint while the robot moves the ankle of the subject strongly.(At the beginning and end of 3-week training, and 1 month after the treatment ends)
- Active range of motion (AROM)(At the beginning and end of 3-week training, and 1 month after the treatment ends)
- 10-meter Walk Test(At the beginning and end of 3-week training, and 1 month after the treatment ends)
- Strength of the ankle flexor-extensor muscle will be measured in Newtons(At the beginning and end of 3-week training, and 1 month after the treatment ends)
- Berg Balance Scale(At the beginning and end of 3-week training, and 1 month after the treatment ends)
- Modified Ashworth Scale (MAS)(At the beginning and end of 3-week training, and 1 month after the treatment ends)