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TerminatedNCT03621254Updated Nov 9, 2026

Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury

An interventional study of [LO-LONG] and [HI-SHORT in Spinal Cord Injury, sponsored by Swiss Paraplegic Research, Nottwil. Terminated at 1 site in Switzerland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Swiss Paraplegic Research, Nottwil · Not applicable, Interventional, and Treatment

Why this study was terminated
insufficient recruitment
Updated Nov 9, 2026Now TerminatedPrimary completion moved+2 moreGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 47 studies in Spinal Cord Injuries by Swiss Paraplegic Research, Nottwil — 8 open to participants now, 8 under way, none of them phase 3. Spinal Cord Injuries · Swiss Paraplegic Research, Nottwil.

Enrollment
18th of 24
18 · median 20
Started
2019
with 4 others
No phase
20 of 47
6 open now
Registered
21st of 47
by date

Among the 47 studies in Spinal Cord Injuries by Swiss Paraplegic Research, Nottwil, this one is the 18th largest by enrollment of the 24 interventional ones that give a count, is one of 5 that started in 2019, is one of 20 with no phase, and was the 21st registered.

Spinal Cord Injuries

2,026 studies on the registry are indexed under Spinal Cord Injuries; 538 are open to participants now.

Browse Spinal Cord Injuries studies →

Open to participants now

8 of the 47 studies in Spinal Cord Injuries by Swiss Paraplegic Research, Nottwil are open now, in 3 countries. Recruiting first, the newest first:

3 more — sign in →

By country, each count listing its studies:

All 8 open studies →

Where they have run

Who these studies take

Of the 375 Spinal Cord Injuries studies recruiting now, 166 (44%) set no upper age limit and 158 (42%) stop at 75 or younger; 41 take children under 18; 52 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

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02

Study summary

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.

03

Conditions studied

  • Spinal Cord Injury

Keywords

  • Functional Electrical Stimulation
  • Exercise Training
  • Aerobic Fitness
  • Muscle Strength
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • 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

  • 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]

Interventions

  • 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.

  • Other[HI-SHORT

    One intervention (\[HI-SHORT\]) uses a variety of leg exercise interval training of higher intensity for 10 x 2-min intervals.

06

What researchers measure

Primary outcomes

  1. Aerobic Fitness

    Change of Peak Oxygen Uptake - VO2peak (L/min)

    Time frame: Day 0 to 6 weeks

Secondary outcomes

  1. Muscle Near Infrared Spectroscopy

    Change of resting muscle arterial oxygen saturation (%)

    Time frame: Day 0 to 6 Weeks

  2. Strength Fitness

    Change of Peak Power Output (Watts)

    Time frame: Day 0 to 6 weeks

Other outcomes

  1. Muscle Volume

    Changes of muscle volume (L)

    Time frame: Day 0 to 6 weeks

  2. Muscle Fatigue

    Changes of time (sec) until muscle fatigue occurs as defined by fall of Power Output (Watts) to 20% of original value

    Time frame: Day 0 to 6 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Jan 2019 to primary completion in Nov 2025, 81 months.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 9, 2026: primary completion Dec 2026 → Nov 2025 and completion Dec 2026 → Nov 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 13, 2018
First posted
Aug 8, 2018
StartActual
Jan 7, 2019
Primary completionActual
Nov 5, 2025was Dec 2026
CompletionActual
Nov 2, 2026was Dec 2026
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Terminated insufficient recruitment
changed Nov 9, 2026
Primary completion
Dec 2026→Nov 5, 2025 (actual)
Nov 9, 2026
Study completion
Dec 2026→Nov 2, 2026 (actual)
Nov 9, 2026
Enrollment
20 (estimated)→18 (actual)
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    Recruiting→Terminated
    Why stopped insufficient recruitment
    Primary completion Dec 2026→Nov 5, 2025 (now actual)
    Study completion Dec 2026→Nov 2, 2026 (now actual)
    Enrollment 20 (estimated)→18 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03621254
Lead sponsor
Swiss Paraplegic Research, Nottwil
Responsible party
Sponsor
First posted
Aug 8, 2018
Start date
Jan 7, 2019
Primary completion
Nov 5, 2025
Completion
Nov 2, 2026
Last update
Nov 9, 2026

Study contacts

Glen M Davis, Prof. Dr.
principal investigator · University of Sydney

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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