Comparative Effects of 2Hz Versus 100Hz Transcutaneous Electrical Nerve Stimulation on Upper Limb Motor Function Post-Stroke: Design and Rationale for a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 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
This study tests whether slow or fast electrical nerve stimulation (TENS) works better to improve arm movement in people recovering from a stroke. Participants will receive TENS on their weak arm three times a week for eight weeks. The results will help find the best TENS setting to support stroke recovery.
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
- Triple (Participant, Investigator, 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
- •Age 18 to 85 years
- •Clinical diagnosis of stroke (ischemic or hemorrhagic) within the past 10 days to 2 months
- •Presence of voluntary movement in the non-paretic arm and at least minimal antigravity movement in the paretic shoulder
- •At least 5 degrees of active wrist extension on the paretic side
- •Able to provide informed consent
排除标准
- •Uncontrolled medical, cardiovascular, or orthopedic conditions
- •Contraindications to TENS (e.g., implanted cardiac pacemaker, skin allergies)
- •Receptive aphasia preventing informed consent or cooperation
- •Significant peripheral neuropathy affecting upper limbs
- •Current participation in another clinical trial or drug study
- •Severe contractures in the shoulder, elbow, wrist, or fingers
研究组 & 干预措施
Placebo TENS Group
干预措施: Placebo TENS (Device)
No-treatment Control Group
2Hz TENS Group
干预措施: Low-frequency(2HZ) TENS (Device)
100Hz TENS Group
干预措施: High-frequency(100HZ) TENS (Device)
结局指标
主要结局
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
时间窗: Baseline, Week 4, Week 8, 1-month follow-up, and 3-month follow-up
Assesses upper limb motor function in stroke patients, including shoulder, elbow, wrist, and hand movements. Scores range from 0 to 66, with higher scores indicating better motor function.
次要结局
- Manual Muscle Testing (MMT) for Wrist Flexion and Extension(Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up)
- Modified Ashworth Scale (MAS) for Wrist Flexor Spasticity(Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up)
- Lindmark Motor Score - Grasp Function Subscale(Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up)
- Barthel Index(Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up)
研究者
CHENGNING Song
Doctor
Shenzhen Baoan District Fuyong People's Hospital