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The Application of Thermal Stimulation on Functional Recovery of Stroke Patients

2015年4月6日 更新者：Jau-Hong Lin, Professor、Kaohsiung Medical University Chung-Ho Memorial Hospital
In literature review, thermal stimulation (TS) intervention is effective in facilitating upper extremity functional recovery in stroke patients. In addition, several functional MRI studies have indicated that thermal stimuli promoted activation in the premotor and motor cortices of healthy participants. These imply the possibility of TS in cortical reorganization. However, there were no studies exploring the relationship of the TS intervention and cortical reorganization. By the functional recovery of stroke patients, findings of brain image and brain mapping, it could enhance the understanding the TS influences on brain reorganization. Regarding with clinical application of the TS intervention for improving functional performance of upper extremity in participants with stroke, the best parameters of TS intervention in clinical practice have not been decided. Therefore, this five-year study recruited three groups of stroke patients (acute, sub-acute, chronic) undergoing TS intervention with different parameters. Functional scales, kinematic data, brain image were taken in several timelines as outcome measures.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The thermal stimulation (TS) intervention uses the heat and cold apply alternately (~30minutes), and this kind temperature application is common in clinical neuromuscular or sports rehabilitation. Moreover, some studies have proved efficacy of the TS on stroke. However, the best parameters and application on different-stage stroke groups have not been clearly explored. Moreover, in order to discover the TS intervention influences on neuroplasticity, the brain images and the brain mapping are taken in the group A (explained in the below). In addition, the kinematic data was also collected in group A. However, the above-mentioned three examination are optional. Finally, functional recovery measurements (clinical scales) are measured in the three groups.

There are three groups (90 participants in each group) and their respective TS intervention design. In other word, three sub-studies (A, B, C) are under this project. Group A recruited 90 acute stroke (~ 30 days) and the independent variable is temperature of TS intervention. Group B is with sub-acute stroke (3-12 months), undergoing different frequency of TS intervention. Group C targets on participants with chronic stroke (> 1 y/o) and this variation in TS is intensity of TS application (30 mins vs 60 mins/each session).

研究类型

介入性

注册 (实际的)

220

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

  • 台湾
      • Kaohsiung city、台湾、807
        • Kaohsiung Medical University

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

18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:

  1. first-ever ischemic stroke;
  2. no severe cognitive impairments and able to follow instructions;
  3. sit on a chair for more than 30 minutes independently.

Exclusion Criteria:

  1. musculoskeletal or cardiac disorders that potentially interferes with experimental tests;
  2. diabetic or sensory impairment that attributable to peripheral vascular disease or neuropathy;
  3. speech disorder or global aphasia;
  4. skin problems at the sites of stimulation;

6.contraindications of heat or ice application.

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：阶乘赋值
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Noxious TS in study A
其他：Noxious TS
hot, cold alternately, noxious TS in study A
有源比较器：Innocuous TS
Innocuous TS in study A
其他：Innocuous TS
warm, cool alternately, Innocuious TS in study A
实验性的：High Frequency of Noxious TS
High Frequency of Noxious TS in study B
其他：High Frequency of Noxious TS
High Frequency of Noxious TS in study B
有源比较器：Low Frequency of Noxious TS
Low Frequency of Noxious TS in study B
其他：Low Frequency of Noxious TS
Low Frequency of Noxious TS in study B
实验性的：High Intensity of Noxious TS
High Intensity of Noxious TS in study C
其他：High Intensity of Noxious TS
High Intensity of Noxious TS in study C
有源比较器：Low Intensity of Noxious TS
Low Intensity of Noxious TS in study C
其他：Low Intensity of Noxious TS
Low Intensity of Noxious TS in study C

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
Movement performance assessment
大体时间：baseline, half time-line of whole intervention period, post-intervention, 1 month follow-up, 6 month follow-up
  • Movement performance assessment by clinical motor assessment scales in upper extremity
  • executed by qualified physiotherapy
  • in study A, B, C
baseline, half time-line of whole intervention period, post-intervention, 1 month follow-up, 6 month follow-up
Brain images
大体时间：immediate effects in 3 timeline
  • "intermediate effect of TS" means: pretest of the single TS, then application of this single TS, finally post-test of this TS in the session in the same day
  • immediate effects of intervention in the 1st day and 24th of intervention, six-month follow-up
  • this examination is optional
  • in study A.
  • use regular scan examination of hospital and operated by trained qualified professionals, the attending is consulted
  • This examination can be stopped at any time if participants do not want to perform or feeling unwell
immediate effects in 3 timeline
Mapping of brain cortex
大体时间：immediate effect in four timeline
  • "intermediate effect of TS" means: pretest of the single TS, then application of this single TS, finally post-test of this TS in the session in the same day
  • immediate effects of intervention in the 1st day and 24th of intervention, one-month follow-up, six-month follow-up
  • in study A.
  • this examination is optional
  • use equipment of brain mapping and operated under trained staff, the attending is consulted This examination can be stopped at any time if participants do not want to perform or feeling unwell
immediate effect in four timeline
Kinematics measure of upper extremity movement
大体时间：four timeline
  • 1st day and 24th of intervention, one-month follow-up, six-month follow-up (This examination is optional)
  • signal emission marks are sticked on surface skin during motion tests

  • this examination is optional

    --in study A.

  • executed by trained qualified physiotherapy
four timeline

次要结果测量

结果测量
措施说明
大体时间
Quality of life
大体时间：baseline, post-intervention, 6 month follow-up
  • Quality of life by subjective questionnaires
  • executed by qualified physiotherapy --in study A, B, C.
baseline, post-intervention, 6 month follow-up

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。

赞助

Kaohsiung Medical University Chung-Ho Memorial Hospital

合作者

E-DA Hospital
Kaohsiung Municipal Hsiaokang Hospital

调查人员

  • 首席研究员：Jau-Hong Lin, Professor、Kaohsiung Medical University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2010年1月1日

初级完成 (实际的)

2014年6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

2011年6月26日

首先提交符合 QC 标准的

2011年8月16日

首次发布 (估计)

2011年8月17日

研究记录更新

最后更新发布 (估计)

2015年4月8日

上次提交的符合 QC 标准的更新

2015年4月6日

最后验证

2015年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • NHRI-EX99-9907PI

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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