Scalp Acupuncture for Motor Dysfunction in Ischemic Stroke: a Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Change from Baseline FMA at 4 weeks, 8 weeks
研究概览
简要总结
The investigators design a randomized, control study to evaluate the therapeutic effect of scalp acupuncture using Jiao's motor area for motor dysfunction in ischemic stroke patients using the following outcomes: motor function, activity of daily living,quality of life.
详细描述
Functional disorder is a common and serious consequence of stroke. A large proportion of stroke patients develop motor dysfunction in the early stage after stroke. Acupuncture is often used as an adjunct to mainstream rehabilitation after stroke. Jiao's scalp acupuncture is a contemporary acupuncture technique integrating traditional Chinese needling methods with western medical knowledge of representative areas of the cerebral cortex. It has been widely applied to be a kind of effective treatment for stroke in China. But, there is meta-analysis suggests that with stroke rehabilitation, acupuncture has no additional effect on motor recovery but has a small positive effect on disability, which may be due to a true placebo effect and varied study quality. The efficacy of acupuncture without stroke rehabilitation remains uncertain, mainly because of the poor quality of such studies.
The objective of this proposed study is to determine whether scalp acupuncture treatment could improve significantly motor function in ischemic stroke patients.
In this 8-week, assessor-blind, randomized, controlled study of scalp acupuncture as additional treatment with the rehabilitation treatment, a total of 116 patients with ischemic stroke patients will be recruited. The patients will be randomly assigned to scalp acupuncture combined with rehabilitation treatment (n =58) or rehabilitation treatment (n =58). (40 sessions, 5 sessions a week). Changes in the motor function over time are measured using Fugl-Meyer Scale, Modified Barthel Index and SS-QOL scale. The study will be conducted at Shanghai University of Traditional Chinese Medicine, Long Hua Hospital, Fudan University, Hua Shan Hospital.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The ages of stroke patients from 40 years old to 70 years old
- •Stroke diagnosed according to the criteria of cerebral arterial thrombosis in Western medicine and apoplexy in Chinese medicine
- •Ischemic stroke confirmed by CT brain or MRI brain, with stable medical condition and awareness clear
- •Recent stroke from 1 month to 6 months after onset
- •Stroke with limb motor dysfunction
- •Sufficient cognition to follow commands and Mini-Mental State Examination (MMSE) score > 24
- •Voluntary participation and informed consent signed.
排除标准
- •Stroke with conscious disturbance or serious cognitive impairment
- •Presence of another chronic disorder, including severe Parkinson's disease, cardiac disease, cancers, epilepsy, or chronic alcoholism
- •Impaired hepatic or renal function
- •bleeding tendency
- •Being oversensitive to acupuncture
- •participation in another clinical trial.
研究组 & 干预措施
Acupuncture combined rehabilitation
Scalp acupuncture treatment
Rehabilitation treatment
干预措施: Scalp Acupuncture Treatment (Device)
Rehabilitation
Rehabilitation treatment
干预措施: Rehabilitation treatment (Other)
结局指标
主要结局
Change from Baseline FMA at 4 weeks, 8 weeks
时间窗: The FMA will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (1 month, 2 months).
The Fugl-Meyer Assessment (FMA) scale for motor function, the FMA was developed as the first quantitative evaluative instrument for measuring sensorimotor stroke recovery, which includes an assessment of the upper extremity (UE, 66 points) and lower extremity (LE, 34 points). The motor domain has well-established reliability and validity as an indicator of motor impairment severity across different stroke recovery time points
次要结局
- Change from Baseline SS-QOL at 4 weeks, 8 weeks(The SS-QOL will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (1 month, 2 months).)
- Change from Baseline SSTCM at 4 weeks, 8 weeks(The SSTCM will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (1 month, 2 months).)
- Change from Baseline MBI at 4 weeks, 8 weeks(The MBI will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (1 month, 2 months).)