Different Stimulation Patterns to Reduce Muscle Fatigue During FES

NHS Trust

Status: Terminated

Conditions: Spinal Cord Injuries

Treatments: Procedure: CSS/AsynS; Procedure: CSS/AsynR

Study type: Interventional

Funder types: Other

Identifiers

NCT03254862

GN17NE114

Details and patient eligibility

About

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).

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Group A: CSS & AsynS

Experimental group

Description:

Electrical stimulation training on both legs: Conventional synchronous stimulation (CSS) and Asynchronous Sequential Stimulation (ASynS) - CSS/ASynS

Treatment:

Procedure: CSS/AsynS

Group B: CSS & AsynR

Experimental group

Description:

Electrical stimulation training on both legs: Conventional synchronous stimulation (CSS) and Asynchronous Random Stimulation (ASynR) - CSS/ASynR

Treatment:

Procedure: CSS/AsynR