Different Stimulation Patterns to Reduce Muscle Fatigue During FES

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-14

Study Completion Date

2018-06-30

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).

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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.

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group A: CSS & AsynS

Electrical stimulation training on both legs:

Conventional synchronous stimulation (CSS) and Asynchronous Sequential Stimulation (ASynS) - CSS/ASynS

Group Type EXPERIMENTAL

CSS/AsynS

Intervention Type PROCEDURE

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

Group B: CSS & AsynR

Electrical stimulation training on both legs:

Conventional synchronous stimulation (CSS) and Asynchronous Random Stimulation (ASynR) - CSS/ASynR

Group Type EXPERIMENTAL

CSS/AsynR

Intervention Type PROCEDURE

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.

Interventions

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CSS/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

Intervention Type 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 Random Stimulation (ASynR) on the other leg.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No