Sensory-Motor Rehabilitation Post Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Changes of Fugl-Meyer Lower Extremity (FMLE)
研究概览
简要总结
Early after stroke, patients often have significant motor impairment and sensory deficit. Evidence has demonstrated heightened plasticity and significant recovery in the acute phase (first months) post stroke but there has been a lack of effective and practical protocols and devices for early intensive sensorimotor therapy.This research study will conduct a 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.
详细描述
The study will investigate an early intensive rehabilitation in acute stroke for motor relearning, reducing ankle impairments and improving balance and mobility/locomotion functions.
The acute stroke survivor will be randomly placed into two groups. Subjects in the Study group will receive robot-aided motor relearning 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 in the middle ROM without intelligent stretching and active movement training without robotic guidance.
For both groups, the therapeutic training will be conducted during 5 hourly sessions (including breaks/transitions between tasks) each week over about 3-week hospital stay. Both groups will also receive the standard of care in the hospital and rehabilitation service. Treatment outcome measures will be obtained through blinded assessments and evaluated before and after training involving biomechanical, neuromuscular and clinical outcome measures. Carry-over effects will be further evaluated 1 month after the treatment ends.
Aim 1: To evaluate biomechanical and neuromuscular changes as defined by the passive and active range of motion (ROM), 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.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First time unilateral acute stroke, hemorrhagic or ischemic, 24 hours after admission in hospital to 1 year post stroke.
- •Hemiplegia or hemiparesis
- •Ankle impairments
排除标准
- •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
研究组 & 干预措施
Study group
Subjects in the Study group will receive stretching and active movement training with robotic guidance and intelligent control
干预措施: stretching and active movement training (Device)
Control group
Subjects in the Control group will receive stretching and active movement training without robotic guidance.
干预措施: stretching and active movement training (Device)
结局指标
主要结局
Changes of 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 assessment is a measure of lower extremity (LE) motor and sensory impairments.
次要结局
- Changes of ankle stiffness(At the beginning and end of 3-week training, and 1 month after the treatment ends)
- Changes of passive range of motion (PROM)(At the beginning and end of 3-week training, and 1 month after the treatment ends)
- Changes of active range of motion (AROM)(At the beginning and end of 3-week training, and 1 month after the treatment ends)
- Changes of Modified Ashworth Scale (MAS)(At the beginning and end of 3-week training, and 1 month after the treatment ends)
- Changes of ankle strength(At the beginning and end of 3-week training, and 1 month after the treatment ends)
- Changes of Berg Balance Scale(At the beginning and end of 3-week training, and 1 month after the treatment ends)
- Changes of 10 meter Walk Test(At the beginning and end of 3-week training, and 1 month after the treatment ends)
研究者
Li-Qun Zhang
Principal Investigator
University of Maryland, Baltimore