Different Stimulation Patterns to Reduce Muscle Fatigue During FES

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Procedure: CSS/AsynS
* Procedure: CSS/AsynR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: CSS & AsynS<br>Electrical stimulation training on both legs: Conventional synchronous stimulation (CSS) and Asynchronous Sequential Stimulation (ASynS) - CSS/ASynS | Procedure: CSS/AsynS<br>* 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<br>|
| Experimental: Group B: CSS & AsynR<br>Electrical stimulation training on both legs: Conventional synchronous stimulation (CSS) and Asynchronous Random Stimulation (ASynR) - CSS/ASynR | Procedure: CSS/AsynR<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle contraction ability | Change in torque produced during muscle contraction | Baseline to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalized Fatigue Index (NFI) | Change in score on Normalized Fatigue Index (NFI) | Baseline to 6 weeks | 
| Fatigue Time Interval (FTI) | Change in Fatigue Time Interval (FTI) | Baseline to 6 weeks | 
| Twitch-Tetanus Ratio response (ΔTTR) | Change in Twitch-Tetanus Ratio response (ΔTTR) | Baseline to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional electrical stimulation