Effectiveness of Intelligent Rehabilitation Robot Training System Combined With Repetitive Facilitative Exercise on Upper Limb Motor Function After Stroke: a Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
研究概览
简要总结
The goal of this clinical trial is to learn if intelligent rehabilitation robot training system combined with repetitive facilitative exercise (RFE) work to treat stroke in adults. The main questions it aims to answer are:
Does drug intelligent rehabilitation robot training system combined with RFE improve the upper limb motor function of participants? Can the combination of intelligent rehabilitation robot training system and RFE achieve better effects?
Researchers will compare 3 groups (RFE, intelligent rehabilitation robot training system under RFE, and conventional therapy) to see if intelligent rehabilitation robot training system and RFE works to treat stroke.
Participants will:
Receive treatment for 4 weeks Receive scale and instrument testing before and after treatment
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients (18 to 74 years old) who suffered a first or second unilateral stroke
- •chronic stroke (over 6 months from the onset)
- •obvious upper limb movement disorders (FMA-UE scores from 25 to 42)
- •ability to understand and follow simple directions
排除标准
- •pregnant or lactating
- •upper extremity contracture, pain, or trauma
- •perceptual, apraxic, or cognitive deficits that lead to inability to follow verbal instructions
- •unable to maintain sitting posture
- •cerebellar lesion
- •clinically unstable medical disorders
- •inability to provide informed consent
结局指标
主要结局
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
时间窗: From enrollment to the end of treatment at 4 weeks
The FMA-UE consists of 33 items across nine components, including reflex action, synergy, and coordination, with a maximum score of 66 points. Each items is scored from 0 (no ability) to 2 (full ability), with higher scores indicating better upper limb motor function.
Active Participation Proportion
时间窗: From enrollment to the end of treatment at 4 weeks
Active Participation Proportion (APP) is measured using the benchmark evaluation system within the intelligent rehabilitation robot training system. The robotic arm's mechanical sensor continuously detects the force exerted by the patient during the test game and quantifies APP as the ratio of the patient's applied force to the total force required to complete the task (%). A higher APP indicates greater voluntary effort in movement execution. Since the test game difficulty is fixed, APP increases as the patient's motor ability improves.
Trajectory Deviation
时间窗: From enrollment to the end of treatment at 4 weeks
Trajectory Deviation (TD) is assessed by comparing the actual motion trajectory with a predefined reference trajectory using the intelligent rehabilitation robot training system. TD is calculated as the mean Euclidean distance (in mm) between discrete points along the actual movement path and the nearest corresponding points on the reference trajectory. This metric provides a measure of point-specific accuracy and precision in following the ideal movement path, with smaller TD values indicating better trajectory control.
Trajectory Tracking Error
时间窗: From enrollment to the end of treatment at 4 weeks
Description: Trajectory Tracking Error (TTE) quantifies the cumulative deviation between the actual movement path and the predefined reference trajectory. It is computed as the sum of absolute differences in trajectory length between the two paths (in mm). TTE reflects overall movement efficiency and smoothness, capturing the patient's ability to maintain an optimal movement path throughout the task. A lower TTE indicates better movement planning and motor control.
次要结局
未报告次要终点
研究者
Jingzhi Zhang
technician
Nanjing Mingzhou Rehabilitation Hospital