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

U

UGECAM Rhône-Alpes

Status

Enrolling

Conditions

Spinal Cord Injuries

Treatments

Device: Rower assisted by electrostimulation (FES-ROW)

Study type

Interventional

Funder types

Other

Identifiers

NCT04821635
2020-A00416-33 (Other Identifier)
2020-1 (FESROW)

Details and patient eligibility

About

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.

Full 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

Enrollment

35 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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 design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

Rower
Experimental group
Description:
Single group of 35 traumatic paraplegic patients meeting the inclusion criteria will benefit from the FES-ROW protocol during 9 months
Treatment:
Device: Rower assisted by electrostimulation (FES-ROW)

Trial contacts and locations

2

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Central trial contact

Stéphane DRION, M.D; Julie R DI MARCO, M.D

Data sourced from clinicaltrials.gov

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