Facilitating Neuroplastic Changes of Acute Stroke Survivors With Severe Hemiplegia
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 4
- 主要终点
- Fugl-Meyer Lower Extremity (FMLE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Study group - Wearable ankle robot rehab
Wearable rehab robot with motor relearning with real-time feedback, passive stretching under intelligent control; Active movement training with robotic assistance
干预措施: Passive stretching (Device)
Study group - Wearable ankle robot rehab
Wearable rehab robot with motor relearning with real-time feedback, passive stretching under intelligent control; Active movement training with robotic assistance
干预措施: Motor relearning training (Device)
Study group - Wearable ankle robot rehab
Wearable rehab robot with motor relearning with real-time feedback, passive stretching under intelligent control; Active movement training with robotic assistance
干预措施: Gamed-based active movement training (Device)
Control group - Limited wearable ankle robot rehab
The same wearable robot used by the study group will be used for the control group but in a limited way: no motor relearning training under real-time feedback; passive movement in the joint middle range of motion instead of passive stretching; active movement training with no robotic assistance
干预措施: Passive movement (Device)
Control group - Limited wearable ankle robot rehab
The same wearable robot used by the study group will be used for the control group but in a limited way: no motor relearning training under real-time feedback; passive movement in the joint middle range of motion instead of passive stretching; active movement training with no robotic assistance
干预措施: Active movement training (Device)
Control group - Limited wearable ankle robot rehab
The same wearable robot used by the study group will be used for the control group but in a limited way: no motor relearning training under real-time feedback; passive movement in the joint middle range of motion instead of passive stretching; active movement training with no robotic assistance
干预措施: Ankle torque and motion measurement (Device)
结局指标
主要结局
Fugl-Meyer Lower Extremity (FMLE)
时间窗: 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.
次要结局
- 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)
研究者
Li-Qun Zhang
Professor
University of Maryland, Baltimore