Skip to content

Different Stimulation Patterns to Reduce Muscle Fatigue During FES

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03254862
Enrollment
4
Registered
2017-08-21
Start date
2017-08-14
Completion date
2018-06-30
Last updated
2018-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

Keywords

Functional electrical stimulation

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.

Interventions

PROCEDURECSS/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

PROCEDURECSS/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.

Sponsors

University of Glasgow
CollaboratorOTHER
NHS Greater Glasgow and Clyde
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Muscle contraction abilityBaseline to 6 weeksChange in torque produced during muscle contraction

Secondary

MeasureTime frameDescription
Normalized Fatigue Index (NFI)Baseline to 6 weeksChange in score on Normalized Fatigue Index (NFI)
Fatigue Time Interval (FTI)Baseline to 6 weeksChange in Fatigue Time Interval (FTI)
Twitch-Tetanus Ratio response (ΔTTR)Baseline to 6 weeksChange in Twitch-Tetanus Ratio response (ΔTTR)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026