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Spinal Cord InjuriesFES-ROWNCT04821635

Effects of FES-Rowing in Neurological Disorders (FES-ROW)

A study testing Rower assisted by electrostimulation (FES-ROW) in people with Spinal Cord Injuries, run by UGECAM Rhône-Alpes at 2 sites in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The main objective of this project is to measure the increase in aerobic physical and metabolic capacities with a 6-month training on a rower assisted by electrostimulation of lower limbs in a population of adults with traumatic paraplegia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Rower assisted by electrostimulation (FES-ROW)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesFrance
Study dates
Apr 2024to Dec 2026
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Paraplegia with traumatic origin
  • Spinal cord injury AIS (ASIA Impairment Scale) score A and B at least 12 months old
  • Patient having given written consent
  • Patient with social security scheme
  • Ability to obtain a leg extension with a 30-minute electrostimulation program

Who cannot join

  • Protected adults (person in guardianship, curators or legal protection)
  • Presence of contraindication criteria to carrying out a stress test or sustained physical activity decided by the doctor following the person with spinal cord injury.
  • Drug treatment with cardiovascular or antidepressant effect
  • Pressure sore
  • Other associated neurological pathologies (stroke, peripheral neuropathy, myopathy, head trauma, ...)
  • Affection of the shoulders of any etiology that could compromise the ability to use the rower.
  • Spasticity of the lower limbs: Modified Ashworth Scale (MAS) greater than or equal to 2/4 (specifically quadriceps / Hamstrings)
  • Participation in another study

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • HIA Desgenettes

    Lyon, Rhône, 69003

  • SSR Val Rosay UGECAM

    Saint-Didier-au-Mont-d'Or, Rhône, 69370

Other trials in France

About this study

Official title: Effects of Training on a Rower Assisted by Electrostimulation of Lower Limbs in Patients With Neurological Disorders (FES-ROW)

The main objective of this project is to measure the increase in aerobic physical and metabolic capacities with a 6-month training on a rower assisted by electrostimulation of lower limbs in a population of adults with traumatic paraplegia.

Read the detailed description

Beyond the inability to walk, chronic paraplegic patients show an increase in their mortality from cardiovascular pathologies, compared to the same age groups of the general population. It is the hypoactivity induced by neurological impairment that is implicated in the first place in the pathogenesis of these abnormalities. The search for training methods adapted to these patients is justified to limit cardiovascular morbidity and mortality.

The aim of this project is to measure the increase in aerobic physical and metabolic capacities with a 6-month training on a rower assisted by electrostimulation of lower limbs in a population of adults with stabilized paraplegia (non-walkers), of traumatic origin.

Study is divided in two 3-month phases. The first consists on a training on a rowing machine with solicitation of the electrostimulated lower limbs only for a period of 3 months at the rate of 3 sessions of 30 minutes per week. The second consists on a training on a rowing machine with solicitation of the electrostimulated lower limbs and upper for a period of 3 months at the rate of 3 sessions of 30 minutes per week. The evaluations are composed of the measurement of maximum oxygen consumption, muscle and neurological parameters

Being tested
Rower assisted by electrostimulation (FES-ROW)
Keywords
Spinal Cord Injury, Functional Electrical Stimulation, Cardiovascular Prevention, Neuroplasticity, Rehabilitation
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.

  • Rower assisted by electrostimulation (FES-ROW)Device

    1. Pre-inclusion visit
    2. Inclusion visit
    3. Phase 1 Rower-FES with lower limbs (Month 0 to Month 3: M0-M3): Training on a rower with solicitation of the electrostimulated lower limbs only for a period of 3 months at the rate of 3 sessions of 30 minutes per week
    4. Interim assessment visit at Month 3 (M3)
    5. Phase 2 Rower-FES with lower limbs + upper limbs (Month 3 to Month 6: M0-M6): Training on with solicitation of the electrostimulated lower and upper limbs for a period of 3 months at the rate of 3 sessions of 30 minutes per week
    6. Final assessment visit at Month 6 (M6)
    7. End of clinical research visit, 3 months after the end of training (Month 9, M9)
Study groups in NCT04821635
Study groupRoleWhat they receive
RowerExperimentalSingle group of 35 traumatic paraplegic patients meeting the inclusion criteria will benefit from the FES-ROW protocol during 9 months
Receives: Device: Rower assisted by electrostimulation (FES-ROW)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VO2 peak at 6 months (L/min)

    Comparison of the maximum oxygen consumption (VO2 peak in L/min) measured during an incremental maximum stress test on a hand ergometer between the end of training on a rower (M6) and inclusion (M0).

    Measured: 6 months

Secondary outcomes (10)

  1. VO2 peak at 3 and 9 months (L/min)

    Comparison of the maximum oxygen consumption (VO2 peak in L/min) measured during an incremental maximum stress test on a hand ergometer between the end of first training phase (M3) and inclusion (M0) and between the end of the study (M9) and inclusion (M0).

    Measured: 9 months

  2. First ventilatory threshold in the VO2max test at 0, 3, 6 and 9 months (L/min)

    Comparison of the first ventilatory threshold (in L/min) in the VO2max test measured during an incremental maximum stress test on a hand ergometer between the end of first training phase (M3), the end of second phase (M6), the end of the study (M9) and inclusion (M0).

    Measured: 9 months

  3. Maximum electro-induced force at 0, 3, 6 and 9 months (Nm)

    Comparison of maximum electro-induced force (in Newton) assessment with a device for measuring the force of the knee extensor muscles between the end of first training phase (M3), the end of second phase (M6), the end of the study (M9) and inclusion (M0).

    Measured: 9 months

  4. Thigh perimeter at 0, 3, 6 and 9 months (cm)

    Comparison of thigh perimeter (in cm) assessment between the end of first training phase (M3), the end of second phase (M6), the end of the study (M9) and inclusion (M0).

    Measured: 9 months

  5. Maximum power at 0, 3, 6 and 9 months (Watts)

    Comparison of the maximum power (in Watts) developed during the stress test on a hand ergometer between the end of first training phase (M3), the end of second phase (M6), the end of the study (M9) and inclusion (M0).

    Measured: 9 months

  6. Response to stimulation at 0, 3, 6 and 9 months (mA)

    Comparison of the minimum threshold (Intensity in mA) of response to stimulation of the extensor muscles of the knee between the end of first training phase (M3), the end of second phase (M6), the end of the study (M9) and inclusion (M0).

    Measured: 9 months

  7. Assessment of spasticity at 0, 3, 6 and 9 months

    Assessment of spasticity with Ashworth scale (rating from 0 to 4 which is the worst score) and Pendulum test (rating from 1 to 5 which is the worst score) between the end of first training phase (M3), the end of second phase (M6), the end of the study (M9) and inclusion (M0).

    Measured: 9 months

  8. Intensity of osteotendinous reflexes at 0, 3, 6 and 9 months

    Comparison of the intensity of osteotendinous reflexes (Absent, normal and lively / diffuse / polykinetic) between the end of first training phase (M3), the end of second phase (M6), the end of the study (M9) and inclusion (M0).

    Measured: 9 months

  9. Self-assessment at 0, 3, 6 and 9 months

    Self-assessment with Goal Attainment Scaling (GAS) between the end of first training phase (M3), the end of second phase (M6), the end of the study (M9) and inclusion (M0).

    GAS rating is divided in 5 levels:

    • -2: Current level
    • -1: Improvement
    • 0: Expected level after action
    • +1: Level better than expected
    • +2: Maximum level expected

    Measured: 9 months

  10. ASIA (American Spinal Injury Association) score at 0, 6 and 9 months

    Comparison between the end of the study following the remanence period (M9) and the inclusion (M0) and M6 of the parameters of ASIA (American Spinal Injury Association) score.

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2021
  2. Study startApr 2024 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Why it stopped: no participant enrolled

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04821635
Sponsor's protocol ID
2020-1 (FESROW)
Other IDs
2020-A00416-33
Acronym
FES-ROW
Status last verified
Jan 2024
First submitted
17 Mar 2021
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wheeler GD, Andrews B, Lederer R, Davoodi R, Natho K, Weiss C, Jeon J, Bhambhani Y, Steadward RD. Functional electric stimulation-assisted rowing: Increasing cardiovascular fitness through functional electric stimulation rowing training in persons with spinal cord injury. Arch Phys Med Rehabil. 2002 Aug;83(8):1093-9. doi: 10.1053/apmr.2002.33656.

    PubMed 12161830

  • Popovic-Maneski L, Aleksic A, Metani A, Bergeron V, Cobeljic R, Popovic DB. Assessment of Spasticity by a Pendulum Test in SCI Patients Who Exercise FES Cycling or Receive Only Conventional Therapy. IEEE Trans Neural Syst Rehabil Eng. 2018 Jan;26(1):181-187. doi: 10.1109/TNSRE.2017.2771466.

    PubMed 29324409

  • Deley G, Denuziller J, Babault N. Functional electrical stimulation: cardiorespiratory adaptations and applications for training in paraplegia. Sports Med. 2015 Jan;45(1):71-82. doi: 10.1007/s40279-014-0250-2.

    PubMed 25205000

Questions about this trial

What is this clinical trial studying?

A study testing Rower assisted by electrostimulation (FES-ROW) in people with Spinal Cord Injuries, run by UGECAM Rhône-Alpes at 2 sites in France.

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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VO2 peak at 6 months (L/min) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04821635, which also lists 3 linked publications.

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 19 Sep 2025.

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