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

NCT ID: NCT04821635

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Rower

Single group of 35 traumatic paraplegic patients meeting the inclusion criteria will benefit from the FES-ROW protocol during 9 months

Group Type: EXPERIMENTAL

Rower assisted by electrostimulation (FES-ROW)

Intervention Type: 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)

Interventions

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)

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Franche-Comté

OTHER

Sponsor Role: collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role: collaborator

University of Lyon

OTHER

Sponsor Role: collaborator

UGECAM Rhône-Alpes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie R Di Marco, M.D

Role: PRINCIPAL_INVESTIGATOR

UGECAM SSR Val Rosay

Locations

HIA Desgenettes

Lyon, Rhône, France

SSR Val Rosay UGECAM

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

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 12161830 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29324409 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25205000 (View on PubMed)

Other Identifiers

2020-A00416-33

Identifier Type: OTHER

Identifier Source: secondary_id

2020-1 (FESROW)

Identifier Type: -

Identifier Source: org_study_id