Different Stimulation Patterns to Reduce Muscle Fatigue During FES

NHS Greater Glasgow and Clyde4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Spinal Cord Injuries

Interventions

CSS/AsynSPROCEDURE

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

CSS/AsynRPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Queen Elizabeth National Spinal Injuries Unit

Glasgow, United Kingdom

Outcomes

Primary Outcomes

Muscle contraction ability

Change in torque produced during muscle contraction

Time frame: Baseline to 6 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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