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the Effect of WBPC on Subacute Stroke Patients

2020年2月14日 更新者:Wei-Te Wang、Changhua Christian Hospital

Whole body periodic acceleration (WBPA) is a head-to-toe movement. The function WBPA works as adding pulses to the circulation. This motion increases shear stress to the endothelium, which stimulates increased release of endothelial-derived nitric oxide (eNO), prostaglandin E-2, tissue plasminogen activator (TPA) into the circulation, and these substances are cardioprotective and contribute to vasodilatation. The WBPA were not well studied than whole body vibration (WBV), a vertical rocking training machine, and most researches focused on cardioprotective effects. A study revealed the effect of Moderate-Intensity Exercise and Whole-Body Periodic Acceleration on Nitric Oxide release was the same. This instrument is quite safe and was applied to patients with varied diseases in previous study. No sound contraindication was mentioned till now.

Our hypothesis is assuming that the circulation of brain could improve after the intervention of WBPA, and stroke recovery and cadio-pulmonary function will improve subsequently.

研究概览

地位

完全的

条件

详细说明

So the investigators will recruit subacute stroke patients as our subjects. The patient who is booked to our rehabilitation ward for further rehabilitation programs is eligible for our study. the investigators will recruit 30 patients, and randomize them to experimental and control group. This study is going to be single blinded, which the evaluator is blinded to the condition of the subjects. Whether experimental or control groups will received the same intensive rehabilitation programs (6 days a week). The experimental group will receive additional WBPA treatment. The duration will be 30 minutes a time, and the frequency will be 5 days a week, and the treating period will be 3 weeks. The evaluator will assess twice, before and after the experiment period. The measurements include: muscle power, brunnstrom stages, Barthel Index, functional independence measure (FIM), time up and go test, 6 minutes walk test, Fugl-Meyer Assessment, berg balance scale, cardio-pulmonary test. In addition, to confirm the immediate effect of WBPA over brain circulation, the investigators will choose 6 patients to received carotid ultrasonography before and immediately after the WBPA treatment.

研究类型

介入性

注册 (实际的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Changhua、台湾、500
        • Changhua Christian Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Subacute stroke patient onset 1-3 months, age from 40-80 years-old

Exclusion Criteria:

  • Cognition impaired(MMSE<24), not first-ever stroke, MI history, AF, CHF, NIHSS>12

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:With WBPC
Intensive rehabilitation programs :The duration will be 30 minutes a time, and the frequency will be 5 days a week, and the treating period will be 3 weeks additional WBPC: The duration will be 30 minutes a time
The duration will be 30 minutes a time, and the frequency will be 5 days a week, and the treating period will be 3 weeks.
安慰剂比较:Control
Intensive rehabilitation programs: The duration will be 30 minutes a time, and the frequency will be 5 days a week, and the treating period will be 3 weeks without WBPC.
Not treat with WBPC

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Functional independent measurement(FIM)
大体时间:up to 3 weeks
Score from 18 to 126, assessment of degree of disability depends , 18 categories(score from 1~7 points, 1 = <25% independence; total assistance required, 7 = 100% independence), focusing on motor and cognitive function, Represent post-stroke patient's ADL function
up to 3 weeks
Brunnstrom stage,
大体时间:up to 3 weeks
Stage I to V, stage I: flaccid ; stage II: spasticity appeared, associated movement; stage III: increased spasticity, synnergy movement; stage IV: decreased spasticity, breaking synergy; stgae V:most independent movement; stage VI: normal. Represent post stroke limb function
up to 3 weeks
modified Ashworth Scale,
大体时间:up to 3 weeks
From 0 to 4 , evaluate post stroke patient's spasticity, 0: No increase in muscle tone; 1: Slight increase in muscle tone;1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3: Considerable increase in muscle tone, passive movement difficult;4: Affected part(s) rigid in flexion or extension
up to 3 weeks

次要结果测量

结果测量
措施说明
大体时间
quality of life: short form- 36
大体时间:up to 3 weeks
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability
up to 3 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年4月1日

初级完成 (实际的)

2014年12月1日

研究完成 (实际的)

2014年12月1日

研究注册日期

首次提交

2019年1月30日

首先提交符合 QC 标准的

2020年2月14日

首次发布 (实际的)

2020年2月17日

研究记录更新

最后更新发布 (实际的)

2020年2月17日

上次提交的符合 QC 标准的更新

2020年2月14日

最后验证

2020年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • CCH_101101
  • 100-CCH-IRP-62

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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