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Different Stimulation Patterns to Reduce Muscle Fatigue During FES

Primary Purpose

Spinal Cord Injuries

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
CSS/AsynS
CSS/AsynR
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injuries focused on measuring Functional electrical stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Queen Elizabeth National Spinal Injuries Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A: CSS & AsynS

Group B: CSS & AsynR

Arm Description

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

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

Outcomes

Primary Outcome Measures

Muscle contraction ability
Change in torque produced during muscle contraction

Secondary Outcome Measures

Normalized Fatigue Index (NFI)
Change in score on Normalized Fatigue Index (NFI)
Fatigue Time Interval (FTI)
Change in Fatigue Time Interval (FTI)
Twitch-Tetanus Ratio response (ΔTTR)
Change in Twitch-Tetanus Ratio response (ΔTTR)

Full Information

First Posted
August 16, 2017
Last Updated
September 5, 2018
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT03254862
Brief Title
Different Stimulation Patterns to Reduce Muscle Fatigue During FES
Official Title
Investigation of Different Stimulation Patterns to Reduce Muscle Fatigue During Functional Electrical Stimulation (FES)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
Initial difficulties recruiting + main researcher had to withdraw from the study
Study Start Date
August 14, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Functional electrical stimulation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: CSS & AsynS
Arm Type
Experimental
Arm Description
Electrical stimulation training on both legs: Conventional synchronous stimulation (CSS) and Asynchronous Sequential Stimulation (ASynS) - CSS/ASynS
Arm Title
Group B: CSS & AsynR
Arm Type
Experimental
Arm Description
Electrical stimulation training on both legs: Conventional synchronous stimulation (CSS) and Asynchronous Random Stimulation (ASynR) - CSS/ASynR
Intervention Type
Procedure
Intervention Name(s)
CSS/AsynS
Intervention Description
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
Intervention Name(s)
CSS/AsynR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle contraction ability
Description
Change in torque produced during muscle contraction
Time Frame
Baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Normalized Fatigue Index (NFI)
Description
Change in score on Normalized Fatigue Index (NFI)
Time Frame
Baseline to 6 weeks
Title
Fatigue Time Interval (FTI)
Description
Change in Fatigue Time Interval (FTI)
Time Frame
Baseline to 6 weeks
Title
Twitch-Tetanus Ratio response (ΔTTR)
Description
Change in Twitch-Tetanus Ratio response (ΔTTR)
Time Frame
Baseline to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Gollee, DipIng PhD
Organizational Affiliation
University of Glasgow
Official's Role
Study Director
Facility Information:
Facility Name
Queen Elizabeth National Spinal Injuries Unit
City
Glasgow
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Different Stimulation Patterns to Reduce Muscle Fatigue During FES

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