Promoting Neuroplastic Changes of Patients With TBI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 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-TBI including patients who are paralyzed with no motor output. The early acute TBI rehabilitation device will be evaluated in this clinical trial.
详细描述
Early after TBI, patients often have significant sensorimotor impairment. There is heightened neural excitability, which may be used to facilitate recovery in the acute phase post stroke. However, there has been a lack of effective and practical protocols and devices for early intensive sensorimotor therapy. The proposed randomized clinical trial using a wearable rehabilitation robot, muscle electromyography (EMG), and/or potentially brain electroencephalogram (EEG) signal seeks to provide early intensive sensorimotor training facilitated by real-time audiovisual and haptic feedback, intelligent stretching and sensory stimulation, active movement training through motivating movement games to promote neuroplasticity and reduce sensorimotor impairments. For acute TBI survivors who cannot generate any motor output yet, EMG or EEG may be used to detect the earliest re-emerging motor control signal and the robot can be used to provide demo and feedback of the intended movement.
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 - Intensive ankle/hand robot rehab
Ankle/Hand 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 with wearable ankle robot (Device)
Study group - Intensive ankle/hand robot rehab
Ankle/Hand 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 with wearable ankle robot (Device)
Control group - Mild ankle/hand 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 with limited wearable ankle robot (Device)
Study group - Intensive ankle/hand robot rehab
Ankle/Hand 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 with wearable ankle robot (Device)
Control group - Mild ankle/hand 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 with limited wearable ankle robot (Device)
Control group - Mild ankle/hand 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/Wrist torque and motion measurement with limited wearable ankle/wrist robot (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)(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)
- Berg Balance Scale(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)
- Strength of the ankle flexor-extensor muscle(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