Spinal Cord InjuryNCT03621254
Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury
A study testing [LO-LONG] and [HI-SHORT in people with Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- [LO-LONG] and [HI-SHORT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Jan 2019to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Unhealed decubiti at electrode placement area.
- Recurrent and uncontrolled autonomic dysreflexia.
- Active heterotopic ossification.
- Other peripheral or central neurologic injury.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
Ines Bersch, PhD, +41 41 939 42 06, ines.bersch@paraplegie.ch
Kathrin Schafer, MPH, +41 41 939 43 34, kathrin.schafer@paraplegie.ch
About this study
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
- Spinal Cord Injury
- Being tested
- [LO-LONG], [HI-SHORT
- Keywords
- Functional Electrical Stimulation, Exercise Training, Aerobic Fitness, Muscle Strength
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[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-SHORTOther
One intervention ([HI-SHORT]) uses a variety of leg exercise interval training of higher intensity for 10 x 2-min intervals.
| Study group | Role | What they receive |
|---|---|---|
| [HI-SHORT] | Experimental | 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) Receives: Other: [HI-SHORT |
| [LO-LONG] | Active comparator | 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) Receives: Other: [LO-LONG] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic Fitness
Change of Peak Oxygen Uptake - VO2peak (L/min)
Measured: Day 0 to 6 weeks
Secondary outcomes (2)
Muscle Near Infrared Spectroscopy
Change of resting muscle arterial oxygen saturation (%)
Measured: Day 0 to 6 Weeks
Strength Fitness
Change of Peak Power Output (Watts)
Measured: Day 0 to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start7 Jan 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Design
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Glen M Davis, Prof. Dr., Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621254
- Sponsor's protocol ID
- 2018-11
- Status last verified
- Nov 2025
- First submitted
- 13 Jul 2018
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03621254
- Acronym / sponsor ID
- 2018-11
- Conditions
- Spinal Cord Injury
- Keywords
- Functional Electrical Stimulation, Exercise Training, Aerobic Fitness, Muscle Strength
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Controlled Design
| Arm | Type | Receives |
|---|---|---|
| [HI-SHORT] | Experimental | Other: [HI-SHORTHigh-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) |
| [LO-LONG] | Active comparator | Other: [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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [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 | [LO-LONG] |
| [HI-SHORTOne intervention ([HI-SHORT]) uses a variety of leg exercise interval training of higher intensity for 10 x 2-min intervals. | Other | [HI-SHORT] |
Primary outcome
Aerobic Fitness
Time frame: Day 0 to 6 weeks
Change of Peak Oxygen Uptake - VO2peak (L/min)
2 secondary outcomes
Muscle Near Infrared Spectroscopy
Time frame: Day 0 to 6 Weeks
Strength Fitness
Time frame: Day 0 to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Glen M Davis, Prof. Dr. principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [LO-LONG] and [HI-SHORT in people with Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ines Bersch, PhD (+41 41 939 42 06, ines.bersch@paraplegie.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic Fitness (time frame: Day 0 to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.