Clinical trial NCT04821635: Effects of FES-Rowing in Neurological Disorders (FES-ROW)
Official title: Effects of Training on a Rower Assisted by Electrostimulation of Lower Limbs in Patients With Neurological Disorders (FES-ROW)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Spinal Cord Injury
Functional Electrical Stimulation
Cardiovascular Prevention
Neuroplasticity
Rehabilitation
Lead sponsor: UGECAM Rhône-Alpes
Sponsor class: OTHER
Collaborators: name: University of Franche-Comté
name: Hospices Civils de Lyon
name: University of Lyon
First posted: 2021-03-29
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: VO2 peak at 6 months (L/min)
timeFrame: 6 months
Secondary outcomes:
measure: VO2 peak at 3 and 9 months (L/min)
timeFrame: 9 months
measure: First ventilatory threshold in the VO2max test at 0, 3, 6 and 9 months (L/min)
timeFrame: 9 months
measure: Maximum electro-induced force at 0, 3, 6 and 9 months (Nm)
timeFrame: 9 months
measure: Thigh perimeter at 0, 3, 6 and 9 months (cm)
timeFrame: 9 months
measure: Maximum power at 0, 3, 6 and 9 months (Watts)
timeFrame: 9 months
measure: Response to stimulation at 0, 3, 6 and 9 months (mA)
timeFrame: 9 months
measure: Assessment of spasticity at 0, 3, 6 and 9 months
timeFrame: 9 months
measure: Intensity of osteotendinous reflexes at 0, 3, 6 and 9 months
timeFrame: 9 months
measure: Self-assessment at 0, 3, 6 and 9 months
timeFrame: 9 months
measure: ASIA (American Spinal Injury Association) score at 0, 6 and 9 months
timeFrame: 9 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: HIA Desgenettes
state: Rhône
city: Saint-Didier-au-Mont-d'Or
country: France
facility: SSR Val Rosay UGECAM
state: Rhône
Study officials:
affiliation: UGECAM SSR Val Rosay
name: Julie R Di Marco, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.