Robot-Assisted Tai Chi for Upper Limb Rehabilitation in Post-Stroke Patients: A Randomized Controlled Trial on Motor Recovery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Upper Extremity Scale
研究概览
简要总结
This study aims to compare the effectiveness of Robot-Assisted Tai Chi Training (RATT) versus conventional rehabilitation in improving upper limb motor function post-stroke, and to explore the neuromuscular mechanisms of RATT. Participants will be randomly assigned to one of two groups:
- Robot-Assisted Tai Chi Training group: Participants will receive guided Tai Chi arm movements with robotic assistance to enhance coordination and strength.
- Conventional rehabilitation group: Participants will perform standard exercises (e.g., stretching, repetitive task practice).
Both groups will receive 60-minute sessions, administered 5 days a week, over 4 weeks. Researchers will measure improvements using clinical scales (e.g., Fugl-Meyer Assessment) and monitor safety.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with stroke confirmed by neuroimaging (CT/MRI).
- •Fugl-Meyer Assessment for Upper Extremity score of 8-
- •First-ever stroke, with unilateral hemiplegia and time since onset ≤12 months.
- •Aged 40-80 years, regardless of gender.
- •Voluntarily participated and provided written informed consent. Participants meeting all above criteria were enrolled.
排除标准
- •Severe cognitive impairment (Montreal Cognitive Assessment score <10).
- •Poor sitting balance (< Grade 2) or inability to maintain seated position for >60 minutes.
- •Hypertonia (modified Ashworth Scale score >2 in affected limb).
- •Significant hemiplegic shoulder pain (Visual Analogue Scale >3).
- •Severe aphasia (Boston Diagnostic Aphasia Examination score <3).
- •Severe visual impairment precluding robot-assisted upper limb training.
- •Moderate-to-severe depression (17-item Hamilton Depression Rating Scale score >17).
- •Pre-existing neuromuscular disorders, active malignancies, or uncontrolled systemic diseases (cardiac, renal, hepatic).
- •Concurrent participation in other clinical trials affecting study outcomes. Participants meeting any of the above criteria were excluded.
研究组 & 干预措施
Tai Chi-based rehabilitation robot group
干预措施: Robot-Assisted Tai Chi Training (Device)
Conventional rehabilitation group
干预措施: Conventional rehabilitation training (Behavioral)
结局指标
主要结局
Fugl-Meyer Upper Extremity Scale
时间窗: 4 weeks (post-intervention)
Score range 0-66, higher scores indicate better upper limb motor recovery.
次要结局
- Wolf Motor Function Test(4 weeks)
- Shoulder Range of Motion(4 weeks)
- Upper Limb Muscle Strength Assessment(4 weeks)
- Trunk Impairment Scale(4 weeks)
- Stroke-Specific Quality of Life Scale(4 weeks)
- Modified Barthel Index(4 weeks)
研究者
Jing Tao
Professor
Fujian University of Traditional Chinese Medicine