An interventional study of CSS/AsynS and CSS/AsynR in Spinal Cord Injuries, sponsored by NHS Greater Glasgow and Clyde. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-07.
Sponsored by NHS Greater Glasgow and Clyde · Not applicable, Interventional, and Supportive care
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).
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.
Exclusion Criteria:
Electrical stimulation training on both legs: Conventional synchronous stimulation (CSS) and Asynchronous Sequential Stimulation (ASynS) - CSS/ASynS
Procedure: CSS/AsynS
Electrical stimulation training on both legs: Conventional synchronous stimulation (CSS) and Asynchronous Random Stimulation (ASynR) - CSS/ASynR
Procedure: 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 Sequential Stimulation (ASynS) on the other leg
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.
Muscle contraction ability
Change in torque produced during muscle contraction
Time frame: Baseline to 6 weeks
Normalized Fatigue Index (NFI)
Change in score on Normalized Fatigue Index (NFI)
Time frame: Baseline to 6 weeks
Fatigue Time Interval (FTI)
Change in Fatigue Time Interval (FTI)
Time frame: Baseline to 6 weeks
Twitch-Tetanus Ratio response (ΔTTR)
Change in Twitch-Tetanus Ratio response (ΔTTR)
Time frame: Baseline to 6 weeks
Plan to share: No
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This study is terminated, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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NHS Greater Glasgow and Clyde