Different Stimulation Patterns to Reduce Muscle Fatigue During FES

NCT03254862 | Terminated

• 1 other identifier: GN17NE114
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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).

Conditions

Spinal Cord Injuries

Keywords

Functional electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Muscle contraction ability

  Change in torque produced during muscle contraction

  Baseline to 6 weeks

Secondary Outcomes (3)

• Normalized Fatigue Index (NFI)

  Baseline to 6 weeks

• Fatigue Time Interval (FTI)

  Baseline to 6 weeks

• Twitch-Tetanus Ratio response (ΔTTR)

  Baseline to 6 weeks

Study Arms (2)

Group A: CSS & AsynS

EXPERIMENTAL

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

Procedure: CSS/AsynS

Group B: CSS & AsynR

EXPERIMENTAL

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

Procedure: CSS/AsynR

Interventions

CSS/AsynS 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 A: CSS & AsynS

CSS/AsynR 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.

Group B: CSS & AsynR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• incomplete spinal cord injury
• able to give informed consent
• able to sit up in a chair

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

Queen Elizabeth National Spinal Injuries Unit

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Henrik Gollee, DipIng PhD

  University of Glasgow

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 21, 2017
• Study Start: August 14, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)