Effects of FES-Rowing in Paraplegia (FES-ROW) (FES-ROW)

• ClinicalTrials.gov Identifier: NCT04821635
• Recruitment Status: Unknown
• First Posted: March 29, 2021
• Last Update Posted: March 29, 2021
• Sponsor: UGECAM Rhône-Alpes
• Collaborators: University of Franche-Comté; Hospices Civils de Lyon; University of Lyon
• Information provided by (Responsible Party): UGECAM Rhône-Alpes

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injuries	Device: Rower assisted by electrostimulation (FES-ROW)	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effects of Training on a Rower Assisted by Electrostimulation of Lower Limbs in Paraplegic Patients (FES-ROW)
• Estimated Study Start Date: April 2021
• Estimated Primary Completion Date: April 2023
• Estimated Study Completion Date: April 2023

Arms and Interventions

Arm

Intervention/treatment

Experimental: Rower; 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); Pre-inclusion visit; Inclusion visit; 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; Interim assessment visit at Month 3 (M3); 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; Final assessment visit at Month 6 (M6); End of clinical research visit, 3 months after the end of training (Month 9, M9)

Outcome Measures

Primary Outcome Measures :

1. VO2 peak at 6 months (L/min) [ Time Frame: 6 months ]
   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).

Secondary Outcome Measures :

1. VO2 peak at 3 and 9 months (L/min) [ Time Frame: 9 months ]
   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 first training phase (M3) and inclusion (M0) and between the end of the study (M9) and inclusion (M0).
2. First ventilatory threshold in the VO2max test at 0, 3, 6 and 9 months (L/min) [ Time Frame: 9 months ]
   Comparison of the first ventilatory threshold (in L/min) in the VO2max test measured during an incremental maximum stress test on a hand ergometer between the end of first training phase (M3), the end of second phase (M6), the end of the study (M9) and inclusion (M0).
3. Maximum electro-induced force at 0, 3, 6 and 9 months (Nm) [ Time Frame: 9 months ]
   Comparison of maximum electro-induced force (in Newton) assessment with a device for measuring the force of the knee extensor muscles between the end of first training phase (M3), the end of second phase (M6), the end of the study (M9) and inclusion (M0).
4. Thigh perimeter at 0, 3, 6 and 9 months (cm) [ Time Frame: 9 months ]
   Comparison of thigh perimeter (in cm) assessment between the end of first training phase (M3), the end of second phase (M6), the end of the study (M9) and inclusion (M0).
5. Maximum power at 0, 3, 6 and 9 months (Watts) [ Time Frame: 9 months ]
   Comparison of the maximum power (in Watts) developed during the stress test on a hand ergometer between the end of first training phase (M3), the end of second phase (M6), the end of the study (M9) and inclusion (M0).
6. Response to stimulation at 0, 3, 6 and 9 months (mA) [ Time Frame: 9 months ]
   Comparison of the minimum threshold (Intensity in mA) of response to stimulation of the extensor muscles of the knee between the end of first training phase (M3), the end of second phase (M6), the end of the study (M9) and inclusion (M0).
7. Assessment of spasticity at 0, 3, 6 and 9 months [ Time Frame: 9 months ]
   Assessment of spasticity with Ashworth scale (rating from 0 to 4 which is the worst score) and Pendulum test (rating from 1 to 5 which is the worst score) between the end of first training phase (M3), the end of second phase (M6), the end of the study (M9) and inclusion (M0).
8. Intensity of osteotendinous reflexes at 0, 3, 6 and 9 months [ Time Frame: 9 months ]
   Comparison of the intensity of osteotendinous reflexes (Absent, normal and lively / diffuse / polykinetic) between the end of first training phase (M3), the end of second phase (M6), the end of the study (M9) and inclusion (M0).
9. Self-assessment at 0, 3, 6 and 9 months [ Time Frame: 9 months ]

   Self-assessment with Goal Attainment Scaling (GAS) between the end of first training phase (M3), the end of second phase (M6), the end of the study (M9) and inclusion (M0).

   GAS rating is divided in 5 levels:

   • -2: Current level
   • -1: Improvement
   • 0: Expected level after action
   • +1: Level better than expected
   • +2: Maximum level expected
10. ASIA (American Spinal Injury Association) score at 0, 6 and 9 months [ Time Frame: 9 months ]
    Comparison between the end of the study following the remanence period (M9) and the inclusion (M0) and M6 of the parameters of ASIA (American Spinal Injury Association) score.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Julie R DI MARCO, M.D; 04.72.53.21.73; dr.jdimarco@gmail.com

Contact: Stéphane DRION, M.D; 0472366079; dr.sdrion@gmail.com

Locations

France

HIA Desgenettes; Recruiting

Lyon, Rhône, France, 69003

Contact: Stéphane Drion, M.D 0472366079 dr.sdrion@gmail.com

SSR Val Rosay UGECAM; Recruiting

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

Contact: Julie Di Marco, M.D 0472532161 dr.jdimarco@gmail.com

Sponsors and Collaborators

UGECAM Rhône-Alpes

University of Franche-Comté

Hospices Civils de Lyon

University of Lyon

Investigators

• Principal Investigator: Julie R Di Marco, M.D; UGECAM SSR Val Rosay

More Information

Publications:

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.

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.

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.

• Responsible Party: UGECAM Rhône-Alpes
• ClinicalTrials.gov Identifier: NCT04821635
• Other Study ID Numbers: 2020-1 (FESROW); 2020-A00416-33 ( Other Identifier: ID-RCB )
• First Posted: March 29, 2021
• Last Update Posted: March 29, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by UGECAM Rhône-Alpes:

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

Additional relevant MeSH terms:

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