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临床试验/NCT05648162
NCT05648162已完成不适用

Convergence of Acupuncture and Transcranial Direct Current Stimulation(tDCS) Rehabilitation Effect on Motor Function of Patients of Acute Stroke

Pusan National University Yangsan Hospital1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2022年7月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
Change of brain activity

研究概览

简要总结

The purpose of this study is to confirm the convergence effectiveness of on acupuncture of the chinese medicine and the tDCS of the western medicine on motor function for patients with acute stroke compared to the control group.

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 (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Those who within 2 weeks or more and 6 months after a stroke diagnosis.
  • •Those who have a lesion with a cortex or subcortex
  • •Adults over 19 years old
  • •Inpatients and outpatients who can mediate for 4 weeks
  • •Those who can understand and follow the purpose of this study

排除标准

  • •Those who fall under the exclusion criteria for electrical acupuncture or acupuncture or tDCS
  • •Those who have a experience about adverse reaction to the existing electrical acupuncture or acupuncture or tDCS
  • •Those who have major psychiatric diseases such as major depression disorders, schizophrenia, bipolar disorders, and dementia
  • •A person who judges that it is not appropriate for a researcher to participate in this study

研究组 & 干预措施

Electrical acupuncture+ tDCS + NDT-Bobath Rehabilitation

Experimental

Electrical acupuncture, tDCS, and NDT-BOBATH rehabilitation were performed for 30 minutes per time, respectively. The number of intervention was held for about a month, five times a week(a total of 20 times).

干预措施: Electrical acupuncture (Device)

Electrical acupuncture+ tDCS + NDT-Bobath Rehabilitation

Experimental

Electrical acupuncture, tDCS, and NDT-BOBATH rehabilitation were performed for 30 minutes per time, respectively. The number of intervention was held for about a month, five times a week(a total of 20 times).

干预措施: tDCS (Device)

Electrical acupuncture+ tDCS + NDT-Bobath Rehabilitation

Experimental

Electrical acupuncture, tDCS, and NDT-BOBATH rehabilitation were performed for 30 minutes per time, respectively. The number of intervention was held for about a month, five times a week(a total of 20 times).

干预措施: NDT-Bobath Rehabilitation (Other)

Acupuncture + sham tDCS + NDT-Bobath Rehabilitation

Active Comparator

Acupuncture, tDCS, and NDT-BOBATH rehabilitation were performed for 30 minutes per time, respectively. The number of intervention was held for about a month, five times a week(a total of 20 times).

干预措施: Acupuncture (Device)

Acupuncture + sham tDCS + NDT-Bobath Rehabilitation

Active Comparator

Acupuncture, tDCS, and NDT-BOBATH rehabilitation were performed for 30 minutes per time, respectively. The number of intervention was held for about a month, five times a week(a total of 20 times).

干预措施: sham tDCS (Device)

Acupuncture + sham tDCS + NDT-Bobath Rehabilitation

Active Comparator

Acupuncture, tDCS, and NDT-BOBATH rehabilitation were performed for 30 minutes per time, respectively. The number of intervention was held for about a month, five times a week(a total of 20 times).

干预措施: NDT-Bobath Rehabilitation (Other)

结局指标

主要结局

Change of brain activity

时间窗: Baseline and Week 4

The fNIRS(functional Near-Infrared Spectroscopy) is a imaged, instrument assessing average brain activity. Change= (Week 4 Score - Baseline Score).

Change of Korean version of the Fugl-Meyer Assessment Scale(K-FMA) score

时间窗: Baseline and Week 4

The FMA is a validated, instrument assessing average motor function of upper and lower extremity. Possible scores range from 0(worst motor function) to 212(best motor function). Change= (Week 4 Score - Baseline Score).

次要结局

  • Change of Korean version of Modified Barthel Index(K-MBI) score(Baseline and Week 4)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yong-il Shin

Professor

Pusan National University Yangsan Hospital

研究点 (1)

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