Different Stimulation Patterns to Reduce Muscle Fatigue During FES

Not Applicable

Terminated

• Conditions: Spinal Cord Injuries
• Interventions: Procedure: CSS/AsynS; Procedure: CSS/AsynR

• Registration Number: NCT03254862
• Lead Sponsor: NHS Greater Glasgow and Clyde

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2017-08-14
• Study First Submitted: 2017-08-16
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-21
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: CSS & AsynS	CSS/AsynS	Electrical stimulation training on both legs: Conventional synchronous stimulation (CSS) and Asynchronous Sequential Stimulation (ASynS) - CSS/ASynS
Group B: CSS & AsynR	CSS/AsynR	Electrical stimulation training on both legs: Conventional synchronous stimulation (CSS) and Asynchronous Random Stimulation (ASynR) - CSS/ASynR

Primary Outcome Measures

Name	Time	Method
Muscle contraction ability	Baseline to 6 weeks	Change in torque produced during muscle contraction

Secondary Outcome Measures

Name	Time	Method
Fatigue Time Interval (FTI)	Baseline to 6 weeks	Change in Fatigue Time Interval (FTI)
Normalized Fatigue Index (NFI)	Baseline to 6 weeks	Change in score on Normalized Fatigue Index (NFI)
Twitch-Tetanus Ratio response (ΔTTR)	Baseline to 6 weeks	Change in Twitch-Tetanus Ratio response (ΔTTR)

Trial Locations

Locations (1)

Queen Elizabeth National Spinal Injuries Unit; 🇬🇧 Glasgow, United Kingdom