Scalp Acupuncture for Dyskinesia After Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- The Fugl-Meyer Assessment (FMA)
研究概览
简要总结
Scalp acupuncture formed by combining traditional Chinese acupuncture techniques and modern theories in medical anatomy has been widely used to treat ischemic stroke in China, but effective clinical trials that verify its efficacy are lacking. This study proposes to verify the effects of Lu's scalp acupuncture on ischemic stroke by comparing differential improvement of motor function between conventional rehabilitation alone and conventional rehabilitation with Lu's scalp acupuncture.
详细描述
A randomized, controlled, parallel, clinical trial. 116 ischemic stroke patients will be collected with dyskinesia from Longhua Hospital, Shanghai University of Traditional Chinese Medicine and Huashan Hospital, Fudan University in China. All patients will be equally randomized into either a control group (conventional rehabilitation) or an experimental group (scalp acupuncture + conventional rehabilitation). In the control group, patients will receive conventional rehabilitation according to the Guidelines for Stroke Rehabilitation in China. In the experimental group, conventional rehabilitation will be supplemented with oblique acupuncture at approximately 15° and an insertion depth of 25-35 mm in the motor areas of the scalp. Twisting speed will be 200 times per minute. Acupuncture will be performed six times per day in 1-minute bouts, with a 4-minute rest following each bout. Patients in both groups will receive rehabilitation five times per week for 8 consecutive weeks. The primary outcome will be the difference in Fugl-Meyer motor function score between posttreatment (4 weeks, 8 weeks, and 6 months of follow-up) and baseline.
The secondary outcomes will be differences in the Modified Barthel Index, stroke-specific quality of life, and stroke syndrome of traditional Chinese medicine.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet to criteria for diagnosis and efficacy evaluation of stroke, formulated by The State Administration of Traditional Chinese Medicine Encephalopathy Emergency Cooperative Group in 1996 (trial implementation)
- •Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China in 2014 (Neurology Branch of Chinese Medical Association and Cerebrovascular Disease Association of Neurology Branch of Chinese Medical Association, 2015)
- •Ischemic stroke diagnosed by CT or magnetic resonance imaging (MRI), with the presence of stable vital signs and awareness
- •An age of 40-70 years Onset within 1-6 months
- •Motor dysfunction in the extremities
- •A Mini-Mental State Examination (Pangman et al., 2000) score > 24 points
排除标准
- •Consciousness disorder or severe cognitive impairment
- •Severe Parkinson's disease, heart disease, cancer, epilepsy, or chronic alcoholism
- •Hepatic or renal impairment
- •Hemorrhagic tendency
- •Sensitivity to acupuncture
- •Congenital disability
- •Pregnancy
- •Currently participating in other clinical trials
结局指标
主要结局
The Fugl-Meyer Assessment (FMA)
时间窗: 8 week
Fugl-Meyer motor function score can effectively assess the degree of dyskinesia at different times during recovery after stroke.
次要结局
- Stroke syndrome of traditional Chinese medicine (SSTCM)(8 week, 16 week)
- modified Barthel Index (mBI)(8 week, 16 week)
- fractional amplitude of low frequency fluctuation (fALFF)(8 week)
- The Fugl-Meyer Assessment (FMA)(16 week)