Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT03621254

Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury

Led by Swiss Paraplegic Research, Nottwil · Updated on 2025-11-26

20

Participants Needed

1

Research Sites

412 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • More than 6 weeks have passed since spinal cord injury.
  • Traumatic or atraumatic spinal cord injury between vertebrae C7 and T10.
  • Diagnosed with motor complete spinal cord injury (American Spinal Injury Association Impairment Scale A or B).
  • Age between 18 and 75 years.
  • Male or female.
  • Able to flex both knees at least 90 degrees.
  • Able to perform functional electrical stimulation muscle contractions.
  • Able to follow verbal instructions.
Not Eligible

You will not qualify if you...

  • Recent trauma to the lower limb.
  • Severe or infected pressure sores on weight-bearing skin areas.
  • Illness caused by an acute urinary tract infection.
  • Uncontrolled spasticity or pain.
  • History of cardiovascular or cardiorespiratory disease that prevents exercise.
  • Uncontrolled orthostatic hypotension.
  • Unhealed sores where electrodes would be placed.
  • Recurrent and uncontrolled autonomic dysreflexia.
  • Active heterotopic ossification.
  • Other peripheral or central neurological injuries.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, Switzerland, 6207

Actively Recruiting

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Research Team

I

Ines Bersch, PhD

CONTACT

K

Kathrin Schafer, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury | DecenTrialz