Different Stimulation Patterns to Reduce Muscle Fatigue During FES
2018年9月5日 更新者：NHS Greater Glasgow and Clyde
Investigation of Different Stimulation Patterns to Reduce Muscle Fatigue During Functional Electrical Stimulation (FES)
The main aim of this study is to investigate the effect of patterned distribution stimulation compared to conventional stimulation in reducing muscle fatigue during functional electrical stimulation (FES) following spinal cord injury (SCI).
研究概览
详细说明
Functional electrical stimulation (FES) is a commonly used technique in rehabilitation and often associated with rapid muscle fatigue which becomes the limiting factor in its applications.
The main objective of this study is to investigate the effects on the onset of fatigue of conventional synchronous stimulation, as well as asynchronous stimulation that mimic voluntary muscle activation targeting different motor units which are activated sequentially or randomly via multiple pairs of stimulation electrodes.
Three different approaches with various electrode configurations will be investigated, as well as different patterns of stimulation applied to the gastrocnemius muscle.
In addition, the muscle changes during different patterns of stimulation will be evaluated in this study.
研究类型
介入性
注册 (实际的)
4
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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Glasgow、英国
- Queen Elizabeth National Spinal Injuries Unit
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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:
- incomplete spinal cord injury
- able to give informed consent
- able to sit up in a chair
Exclusion Criteria:
- female subjects who are pregnant
- significant history of autonomic dysreflexia
- unable to give informed consent
- individuals who have a cardiac history
- individuals who have significant cognitive impairment
- individuals with muscular abnormality
- individuals who have significant contractures in the lower extremities
- individuals who have a rash or infection at the site of electrode placement (gastrocnemius for both legs)
- individuals who are hypersensitive to electrical stimulation
- individuals who are presently involved in another study which has overlap with the methodology and/or outcomes of the studies
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：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Group A: CSS & AsynS
Electrical stimulation training on both legs: Conventional synchronous stimulation (CSS) and Asynchronous Sequential Stimulation (ASynS) - CSS/ASynS |
16 sessions of training over a 4 week period consisting of repeated intermittent electrical stimulation (300ms On and 700ms Off stimulation) for 10 - 30 minutes.
Conventional synchronous stimulation (CSS) on one leg; Asynchronous Sequential Stimulation (ASynS) on the other leg
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实验性的：Group B: CSS & AsynR
Electrical stimulation training on both legs: Conventional synchronous stimulation (CSS) and Asynchronous Random Stimulation (ASynR) - CSS/ASynR |
16 sessions of training over a 4 week period consisting of repeated intermittent electrical stimulation (300ms On and 700ms Off stimulation) for 10 - 30 minutes.
Conventional synchronous stimulation (CSS) on one leg; Asynchronous Random Stimulation (ASynR) on the other leg.
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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 |
|---|---|---|
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Muscle contraction ability
大体时间：Baseline to 6 weeks
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Change in torque produced during muscle contraction
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Baseline to 6 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Normalized Fatigue Index (NFI)
大体时间：Baseline to 6 weeks
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Change in score on Normalized Fatigue Index (NFI)
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Baseline to 6 weeks
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Fatigue Time Interval (FTI)
大体时间：Baseline to 6 weeks
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Change in Fatigue Time Interval (FTI)
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Baseline to 6 weeks
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Twitch-Tetanus Ratio response (ΔTTR)
大体时间：Baseline to 6 weeks
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Change in Twitch-Tetanus Ratio response (ΔTTR)
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Baseline to 6 weeks
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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
- 研究主任：Henrik Gollee, DipIng PhD、University of Glasgow
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)
2017年8月14日
初级完成 (实际的)
2018年6月30日
研究完成 (实际的)
2018年6月30日
研究注册日期
首次提交
2017年8月16日
首先提交符合 QC 标准的
2017年8月18日
首次发布 (实际的)
2017年8月21日
研究记录更新
最后更新发布 (实际的)
2018年9月7日
上次提交的符合 QC 标准的更新
2018年9月5日
最后验证
2018年9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.
CSS/AsynS的临床试验
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University Hospital Bispebjerg and FrederiksbergRigshospitalet, Denmark终止
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Cochlearnumerics data GmbH完全的
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University of MalagaMinisterio de Ciencia, Innovación y Universidades, Spain邀请报名
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Johns Hopkins Bloomberg School of Public HealthUnited States Agency for International Development (USAID)完全的
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Rigshospitalet, DenmarkHvidovre University Hospital; Bispebjerg Hospital招聘中
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CochlearAvania; QbD Clinical完全的