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RecruitingNCT03621254Updated Nov 26, 2025

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. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-26.

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

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

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.

02

Conditions studied

  • Spinal Cord Injury

Keywords

  • Functional Electrical Stimulation
  • Exercise Training
  • Aerobic Fitness
  • Muscle Strength
03

Who can participate

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

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.
04

Study design

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

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.

05

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

06

Study locations

1 of 1 sites recruiting
  • Swiss Paraplegic Centre
    Nottwil, Canton of Lucerne 6207, Switzerland
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

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
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Nov 26, 2025

Study contacts

Ines Bersch, PhD
Contact
ines.bersch@paraplegie.ch
+41 41 939 42 06
Kathrin Schafer, MPH
Contact
kathrin.schafer@paraplegie.ch
+41 41 939 43 34
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 ↗

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