search
Back to results

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

Primary Purpose

Spinal Cord Injuries

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rower assisted by electrostimulation (FES-ROW)
Sponsored by
UGECAM Rhône-Alpes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injuries focused on measuring Spinal Cord Injury, Functional Electrical Stimulation, Cardiovascular Prevention, Neuroplasticity, Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HIA DesgenettesRecruiting
  • SSR Val Rosay UGECAMRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rower

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

VO2 peak at 3 and 9 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 first training phase (M3) and inclusion (M0) and between the end of the study (M9) and inclusion (M0).
First ventilatory threshold in the VO2max test at 0, 3, 6 and 9 months (L/min)
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).
Maximum electro-induced force at 0, 3, 6 and 9 months (Nm)
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).
Thigh perimeter at 0, 3, 6 and 9 months (cm)
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).
Maximum power at 0, 3, 6 and 9 months (Watts)
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).
Response to stimulation at 0, 3, 6 and 9 months (mA)
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).
Assessment of spasticity at 0, 3, 6 and 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).
Intensity of osteotendinous reflexes at 0, 3, 6 and 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).
Self-assessment at 0, 3, 6 and 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
ASIA (American Spinal Injury Association) score at 0, 6 and 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.

Full Information

First Posted
March 17, 2021
Last Updated
March 24, 2021
Sponsor
UGECAM Rhône-Alpes
Collaborators
University of Franche-Comté, Hospices Civils de Lyon, University of Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT04821635
Brief Title
Effects of FES-Rowing in Paraplegia (FES-ROW)
Acronym
FES-ROW
Official Title
Effects of Training on a Rower Assisted by Electrostimulation of Lower Limbs in Paraplegic Patients (FES-ROW)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UGECAM Rhône-Alpes
Collaborators
University of Franche-Comté, Hospices Civils de Lyon, University of Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal Cord Injury, Functional Electrical Stimulation, Cardiovascular Prevention, Neuroplasticity, Rehabilitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rower
Arm Type
Experimental
Arm Description
Single group of 35 traumatic paraplegic patients meeting the inclusion criteria will benefit from the FES-ROW protocol during 9 months
Intervention Type
Device
Intervention Name(s)
Rower assisted by electrostimulation (FES-ROW)
Intervention Description
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)
Primary Outcome Measure Information:
Title
VO2 peak at 6 months (L/min)
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
VO2 peak at 3 and 9 months (L/min)
Description
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).
Time Frame
9 months
Title
First ventilatory threshold in the VO2max test at 0, 3, 6 and 9 months (L/min)
Description
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).
Time Frame
9 months
Title
Maximum electro-induced force at 0, 3, 6 and 9 months (Nm)
Description
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).
Time Frame
9 months
Title
Thigh perimeter at 0, 3, 6 and 9 months (cm)
Description
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).
Time Frame
9 months
Title
Maximum power at 0, 3, 6 and 9 months (Watts)
Description
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).
Time Frame
9 months
Title
Response to stimulation at 0, 3, 6 and 9 months (mA)
Description
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).
Time Frame
9 months
Title
Assessment of spasticity at 0, 3, 6 and 9 months
Description
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).
Time Frame
9 months
Title
Intensity of osteotendinous reflexes at 0, 3, 6 and 9 months
Description
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).
Time Frame
9 months
Title
Self-assessment at 0, 3, 6 and 9 months
Description
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
Time Frame
9 months
Title
ASIA (American Spinal Injury Association) score at 0, 6 and 9 months
Description
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.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie R DI MARCO, M.D
Phone
04.72.53.21.73
Email
dr.jdimarco@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane DRION, M.D
Phone
0472366079
Email
dr.sdrion@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie R Di Marco, M.D
Organizational Affiliation
UGECAM SSR Val Rosay
Official's Role
Principal Investigator
Facility Information:
Facility Name
HIA Desgenettes
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane Drion, M.D
Phone
0472366079
Email
dr.sdrion@gmail.com
Facility Name
SSR Val Rosay UGECAM
City
Saint-Didier-au-Mont-d'Or
State/Province
Rhône
ZIP/Postal Code
69370
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Di Marco, M.D
Phone
0472532161
Email
dr.jdimarco@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12161830
Citation
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.
Results Reference
background
PubMed Identifier
29324409
Citation
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.
Results Reference
background
PubMed Identifier
25205000
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs