NCT04821635

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: UGECAM Rhône-Alpes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	Rower assisted by electrostimulation (FES-ROW)	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)

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2021-03-29
• Last updated: 2025-09-19

Locations

2 sites across 1 country: France