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临床试验/NCT03254862
NCT03254862终止不适用

Investigation of Different Stimulation Patterns to Reduce Muscle Fatigue During Functional Electrical Stimulation (FES)

NHS Greater Glasgow and Clyde1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2017年8月14日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
1
主要终点
Muscle contraction ability

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • incomplete spinal cord injury
  • able to give informed consent
  • able to sit up in a chair

排除标准

  • 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

结局指标

主要结局

Muscle contraction ability

时间窗: Baseline to 6 weeks

Change in torque produced during muscle contraction

次要结局

  • Fatigue Time Interval (FTI)(Baseline to 6 weeks)
  • Normalized Fatigue Index (NFI)(Baseline to 6 weeks)
  • Twitch-Tetanus Ratio response (ΔTTR)(Baseline to 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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