Different Stimulation Patterns to Reduce Muscle Fatigue During FES

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03254862
• Other study ID #: GN17NE114
• Status: Terminated
• Phase: N/A
• Start date: August 14, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: September 2018
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Spinal Cord Injuries

Intervention

Procedure:
• 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
• 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.

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth National Spinal Injuries Unit	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle contraction ability	Change in torque produced during muscle contraction	Baseline to 6 weeks
Secondary	Normalized Fatigue Index (NFI)	Change in score on Normalized Fatigue Index (NFI)	Baseline to 6 weeks
Secondary	Fatigue Time Interval (FTI)	Change in Fatigue Time Interval (FTI)	Baseline to 6 weeks
Secondary	Twitch-Tetanus Ratio response (?TTR)	Change in Twitch-Tetanus Ratio response (?TTR)	Baseline to 6 weeks