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NCT Number: NCT03621254

Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[LO-LONG]

Other

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.

[HI-SHORT

Other

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

Primary outcomes

  1. Aerobic Fitness

    Time frame: Day 0 to 6 weeks

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

Secondary outcomes

  1. Muscle Near Infrared Spectroscopy

    Time frame: Day 0 to 6 Weeks

    Change of resting muscle arterial oxygen saturation (%)

  2. Strength Fitness

    Time frame: Day 0 to 6 weeks

    Change of Peak Power Output (Watts)

Other outcomes

  1. Muscle Volume

    Time frame: Day 0 to 6 weeks

    Changes of muscle volume (L)

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ines Bersch, PhD

CONTACT

[email protected]

+41 41 939 42 06

Kathrin Schafer, MPH

CONTACT

[email protected]

+41 41 939 43 34

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Aug 8, 2018
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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