Fatiguing Arm Exercise Following Stroke
2020年6月1日 更新者：VA Office of Research and Development
Neural Mechanisms Mediating Interlimb Transfer Following Stroke
This study investigates the effects of sub-maximal exercise to task-failure (e.g., fatigue) with the less involved, or so-called non-paretic hand, in people who have experienced a stroke.
In previous work the investigators found that non-paretic hand exercise to task-failure increased excitability of the motor cortex in the more involved hemisphere and produced behavioral improvements in the unexercised paretic hand.
Importantly, the magnitude of increased brain excitability is greater than what has been observed following brain stimulation with either repetitive transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (tDCS) and lasts longer.
This approach could be implemented in the clinical setting and could be accessible to a greater number of people than brain stimulation.
The investigators' goals in the current study are to: repeat previous findings in a different group of participants and investigate the neural mechanisms that produce brain and behavioral facilitation in order to inform development of this approach for clinical implementation.
研究概览
详细说明
The long-term goal is to restore upper extremity (UE) motor function following stroke. The overall objective of this proposal is to improve the investigators' understanding of neural mechanisms contributing to inter-limb and inter-hemispheric transfer following non-paretic limb exercise to task failure. The investigators will use transcranial magnetic stimulation to probe acute adaptations in cortical excitability, intracortical and inter-hemispheric circuits that accompany behavioral facilitation of the paretic hand.
The work proposed in this two year project will enable the investigators to obtain three data elements critical to complete the working hypothesis:
- . Changes in intracortical and interhemispheric inhibition in both hemispheres following non-paretic limb exercise to task-failure.
- . Behavioral effects using a motor task involving manipulation and dexterity.
- . Determine the persistence and consistency of neural and behavioral facilitation.
研究类型
介入性
注册 (实际的)
15
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
-
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Florida
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Gainesville、Florida、美国、32608
- North Florida/South Georgia Veterans Health System, Gainesville, FL
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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 及以上 (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:
- individuals at least 6 months post-stroke in the cortical or sub-cortical distribution with residual upper-extremity hemiparesis
- Non-Veteran Participants are eligible
Exclusion Criteria:
- multiple strokes
- strokes in both hemispheres
- brainstem/medullary/cerebellar stroke
- seizure disorder
- metal implants in head or neck
- pacemaker or other implanted device
- inability to produce any measurable grip force
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：基础科学
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Task-failure, Extended Session
Repeated sub-maximal gripping exercise with the less affected hand to task-failure - followed by repeated measurements (5) during recovery period
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participants perform repeated gripping with visual feedback to task failure
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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 |
|---|---|---|
|
Short Intracortical Inhibition (SICI)
大体时间：baseline, post task-failure (minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)
|
SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using transcranial magnetic stimulation (TMS) measured here in the ipsilesional hemisphere (IH) at each point to determine how it is modulated in response to task-failure.
SICI is quantified as a ratio where values <1 reflect inhibition and >1 disinhibition or relative excitation.
In health, SICI is ~0.5.
Thus if SICI = 0.8, while <1 it would indicate less inhibition than expected in health.
Transient change in SICI from 0.8 to 1.1 over the course of this experimental paradigm would reflect a period of relative excitation in response to the exercise paradigm.
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baseline, post task-failure (minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)
|
|
SICI Ratio
大体时间：Baseline, pre-exercise of 8 repeated sessions
|
SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using transcranial magnetic stimulation (TMS) measured here in the ipsilesional hemisphere (IH) at each point to determine how it is modulated in response to task-failure.
SICI is quantified as a ratio where values <1 reflect inhibition and >1 disinhibition or relative excitation.
In health, SICI is ~0.5.
Thus if SICI = 0.8, while <1 it would indicate less inhibition than expected in health.
Transient change in SICI from 0.8 to 1.1 over the course of this experimental paradigm would reflect a period of relative excitation in response to the exercise paradigm.
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Baseline, pre-exercise of 8 repeated sessions
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Box and Blocks Test (BBT)
大体时间：baseline, post task-failure (requires variable timeline from minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)
|
The BBT measures motor function/dexterity, scored as the number of blocks transferred in 1 minute.
Here function of the paretic hand was measured at each time point: baseline, post-task failure, 45min post, 90min post, 135min post, 180min post, 225min post-task failure to determine the change in paretic hand BBT performance following exercise to task-failure.
Scores are numeric ranging from 0 (no blocks transferred) to whatever the participant is able to achieve.
Healthy age-matched adults without motor disability score in the range of 60 (+/- 10) blocks transferred in 1 minute.
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baseline, post task-failure (requires variable timeline from minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)
|
|
Box and Blocks Test (BBT)
大体时间：baseline, pre-exercise of 8 repeated sessions
|
The BBT measures motor function/dexterity, scored as the number of blocks transferred in 1 minute.
Here function of the paretic hand was measured prior to exercise at each of 8 repeated sessions conducted twice weekly for 4 weeks to determine the change in paretic hand BBT performance following repeated sessions of exercise to task-failure.
Scores are numeric ranging from 0 (no blocks transferred) to whatever the participant is able to achieve.
Healthy age-matched adults without motor disability score in the range of 60 (+/- 10) blocks transferred in 1 minute.
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baseline, pre-exercise of 8 repeated sessions
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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。
调查人员
- 首席研究员：Carolynn Patten, PhD、North Florida/South Georgia Veterans Health System, Gainesville, FL
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 (实际的)
2016年2月1日
初级完成 (实际的)
2018年5月21日
研究完成 (实际的)
2018年5月21日
研究注册日期
首次提交
2016年10月14日
首先提交符合 QC 标准的
2017年6月20日
首次发布 (实际的)
2017年6月21日
研究记录更新
最后更新发布 (实际的)
2020年6月4日
上次提交的符合 QC 标准的更新
2020年6月1日
最后验证
2020年6月1日
更多信息
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.
submaximal exercise (grip)的临床试验
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的
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University of South FloridaFlorida High Tech Corridor Council; TRS, Inc.完全的
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Teresa Moreno CasbasFondo de Investigacion Sanitaria完全的
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Rahul AggarwalNational Cancer Institute (NCI); U.S. Army Medical Research Acquisition Activity招聘中