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

NCT04821635 | Withdrawn

• 2 other identifiers: 2020-1 (FESROW)2020-A00416-33
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injury; Functional Electrical Stimulation; Cardiovascular Prevention; Neuroplasticity; Rehabilitation

Outcome Measures

Primary Outcomes (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).

  6 months

Secondary Outcomes (10)

• VO2 peak at 3 and 9 months (L/min)

  9 months

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

  9 months

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

  9 months

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

  9 months

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

  9 months

Study Arms (1)

Rower

EXPERIMENTAL

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

Device: Rower assisted by electrostimulation (FES-ROW)

Interventions

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)

Rower

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UGECAM Rhône-Alpes: lead
• University of Franche-Comté: collaborator
• Hospices Civils de Lyon: collaborator
• University of Lyon: collaborator

Study Sites (2)

HIA Desgenettes

Lyon, Rhône, 69003, France

Location

SSR Val Rosay UGECAM

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

Location

Related Publications (3)

• 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.

  PMID: 12161830 BACKGROUND

• 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.

  PMID: 29324409 BACKGROUND

• 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.

  PMID: 25205000 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Julie R Di Marco, M.D

  UGECAM SSR Val Rosay

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 29, 2021
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)