Using electrostimulation-assisted rowing to improve fitness in adults with spinal cord injuries
Effects of Training on a Rower Assisted by Electrostimulation of Lower Limbs in Patients With Neurological Disorders (FES-ROW)
This study is testing if a special rowing machine that helps move the legs can improve fitness and heart health in adults with spinal cord injuries over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UGECAM Rhône-Alpes Academic / other |
| Locations | 2 sites (Lyon, Rhône and 1 other locations) |
| Trial ID | NCT04821635 on ClinicalTrials.gov |
What this trial studies
This project aims to enhance aerobic physical and metabolic capacities in adults with traumatic paraplegia through a 6-month training program on a rowing machine that utilizes functional electrical stimulation (FES) for the lower limbs. The study is divided into two phases: the first phase focuses on lower limb stimulation only, while the second phase incorporates both lower and upper limb stimulation. Participants will engage in three 30-minute sessions per week, with evaluations measuring maximum oxygen consumption and other muscle and neurological parameters. The goal is to address the increased cardiovascular risks faced by this population due to inactivity.
Who should consider this trial
Good fit: Ideal candidates are adults with traumatic paraplegia who have a stable spinal cord injury and meet specific inclusion criteria.
Not a fit: Patients with other neurological conditions or significant physical limitations that prevent participation in the rowing exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve cardiovascular health and overall fitness in individuals with spinal cord injuries.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using electrostimulation for rehabilitation in spinal cord injury patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lyon, Rhône and 1 other locations
- HIA Desgenettes — Lyon, Rhône, France (Recruiting)
- SSR Val Rosay UGECAM — Saint-Didier-au-Mont-d'Or, Rhône, France (Recruiting)
Study contacts
- Principal investigator: Julie R Di Marco, M.D — UGECAM SSR Val Rosay
- Study coordinator: Julie R DI MARCO, M.D
- Email: dr.jdimarco@gmail.com
- Phone: 04.72.53.21.73
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.