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临床试验/NCT02612441
NCT02612441已完成不适用

The Efficacy of Acupuncture on Patients With First Acute Ischemic Stroke, With Signs of Hemiplegia and Hemiparesis

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2015年11月最近更新:
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
2
试验地点
1
主要终点
(NIHSS)

研究概览

简要总结

Chinese Acupuncture can improve the motor ability of patients after having first acute ischemic stroke, in time scale up to 3 weeks from when the ischemic stroke occur and in minimum receiving number of 3 Acupuncture treatments.

The accepted treatment on cerebral vascular accident (CVA) is focus on two lines: the first is the treatment when the stroke occurs, and the second is prevention from having more cerebral vascular accident in the future.

In the first accepted treatment line, the only medicinal measure that stand up in critique of organized researches, is Tissue Plasminogen Activator (TPA), and there is Short and limited time after the CVA occur that it can be used. Also (TPA) can be used only on part of the patients with specific defined criterions.

The aim of this study is to add a new accepted treatment method that appointed to improve the results of acute ischemic stroke by Chinese Acupuncture. The written works on this topic is unambiguously.

详细描述

The number of participant in the clinical trial: approximately 100 patients. 50 patients will receive Chinese Acupuncture and the others 50 will receive sham Acupuncture.

Stages and work method:

The treatments in Acupuncture will occur every week. Each patient will receive minimum 3 Acupuncture/ sham treatments while staying in the neurology department.

1 After the suitable patients selected to be included in the study, with the assistance of statistical software, the acupuncturist will get from each patient approval to be participating in the study.

  1. The direct physician of all the patients that will be participate in the study will approve the accepted treatment in Acupuncture/ sham and get the patients acceptance by signature.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with first acute ischemic stroke, with preserved cognitive awareness and with the ability to sign on the research agreement forms.
  • Division for two main groups:
  • Group number 1: will get real Acupuncture
  • Group number 2: will get false Acupuncture- ( SHAM).
  • The patients will be selected with the assistance of statistical software which will divide them randomly and equally by the standard Criteria.

排除标准

  • Patients with understanding dysfunction:
  • Dysphasia, sensory aphasia,
  • Patients with cerebral hemorrhage,
  • pregnant women's, children's, and Patients with lack of judgment ability.

研究组 & 干预措施

1 real Acupuncture group-intervention

Experimental

real Acupuncture Needles

干预措施: real Acupuncture Needles (Device)

2 sham Acupuncture group

Sham Comparator

sham Acupuncture Needles

干预措施: sham Acupuncture Needles (Device)

结局指标

主要结局

(NIHSS)

时间窗: 1 week

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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