Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury

November 20, 2025 updated by: Swiss Paraplegic Research, Nottwil
The aim of this study is to investigate two different modalities of functional electrical stimulation (FES) leg exercise in patients with spinal cord injury (SCI). The primary outcomes being compared are 1. FES-induced leg aerobic fitness, and 2. FES-induced leg strength. There will be two FES-leg training groups, and sub-acute patients with SCI will be randomised between the groups - high-short [HI-SHORT] and low-long [LO-LONG]. Both groups (n=10 per group) will exercise on the Hasomed RehaStim™ exercise ergometer for 6-8 weeks, three-four times per week (24 therapy sessions). [HI-SHORT] will perform 10 x 2-min of high-intensity interval training with a recovery of 1-2 min between exercise bouts. [LO-LONG] will perform 20+ min of continuous exercise at a low-moderate exercise intensity. Exercise intensity for [HI-SHORT] and [LO-LONG] will be titrated by neuromuscular stimulation characteristics. The primary outcomes will be assessed before training commences and after 6-8 weeks of training has been completed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
    • Canton of Lucerne
      • Nottwil, Canton of Lucerne, Switzerland, 6207

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Greater than 6-weeks post-trauma after SCI.
  • Traumatic and atraumatic spinal cord injuries between C7 and T10
  • Participants diagnosed with "motor complete' spinal cord injury American Spinal Injury Association Impairment Scale A and B.
  • Age between 18-75 years old.
  • Both male and female.
  • Have at least 90º bilateral knee flexion.
  • Able to perform FES muscle contractions (not FES intolerant).
  • Able to follow verbal instructions.

Exclusion Criteria:

  • A recent history of trauma to the lower limb.
  • Severe or infected pressure sore on weight-bearing skin areas.
  • Illness caused by acute urinary tract infection.
  • Uncontrolled spasticity or pain.
  • History of cardiovascular / cardiorespiratory disease contraindicating exercise.
  • Uncontrolled orthostatic hypotension.
  • Unhealed decubiti at electrode placement area.
  • Recurrent and uncontrolled autonomic dysreflexia.
  • Active heterotopic ossification.
  • Other peripheral or central neurologic injury.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [HI-SHORT]
High-intensity interval training modality of exercise using FES-evoked leg cycling. Three-four times weekly over 6-8 weeks (24 therapy sessions). The programme is 10 x 2-min exercise intervals with 1-2 min of recovery between intervals. High intensity is achieved by high FES current amplitude (120-150 milliampere, patient dependent)
Other: [HI-SHORT
One intervention ([HI-SHORT]) uses a variety of leg exercise interval training of higher intensity for 10 x 2-min intervals.
Active Comparator: [LO-LONG]
Low-moderate intensity continuous training modality of exercise using FES-evoked leg cycling. Three-four times weekly over 6-8 weeks (24 therapy sessions). The programme is 20+ min continuous exercise. Lower intensity is achieved by lower FES current amplitude (< 90-100 milliampere, patient dependent)
Other: [LO-LONG]
Both interventions are different modalities of FES-evoked leg exercise, three-four times per week for 6-8 weeks (24 therapy sessions). The comparator intervention ([LO-LONG]) uses 20-40 min (patient state of fitness dependent) of continuous leg exercise of lower intensity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aerobic Fitness
Time Frame: Day 0 to 6 weeks
Change of Peak Oxygen Uptake - VO2peak (L/min)
Day 0 to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Near Infrared Spectroscopy
Time Frame: Day 0 to 6 Weeks
Change of resting muscle arterial oxygen saturation (%)
Day 0 to 6 Weeks
Strength Fitness
Time Frame: Day 0 to 6 weeks
Change of Peak Power Output (Watts)
Day 0 to 6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Volume
Time Frame: Day 0 to 6 weeks
Changes of muscle volume (L)
Day 0 to 6 weeks
Muscle Fatigue
Time Frame: Day 0 to 6 weeks
Changes of time (sec) until muscle fatigue occurs as defined by fall of Power Output (Watts) to 20% of original value
Day 0 to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Paraplegic Research, Nottwil

Investigators

  • Principal Investigator: Glen M Davis, Prof. Dr., University of Sydney

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2019

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 13, 2018

First Submitted That Met QC Criteria

August 3, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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