Training for Persons With Complete SCI for FES Cycling: a Case Series

NCT04412447 | Unknown

• 1 other identifier: 2019-A00808-49
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to validate the effectivity of a simple home-based training for cycling with functional electrical stimulation (FES). The training is designed to progressively increase strength and endurance of the paralysed muscles of a person with complete spinal cord injury. After a limited period of only several months, performance will be assessed during FES-assisted cycling on a recumbent tricycle over flat ground. The outcomes of this study should provide evidence for the effectivity of FES-cycling as potential rehabilitation method.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (7)

• Change in Maximum Cycling-Distance in [m]

  Change in maximum distance cycled on flat ground on a tricycle

  Change between 4 months of training (end of V3) and 6 months of training (end of V4)

• Change in Maximum Cycling-Speed in [km/h]

  Change in maximum speed during cycling over flat ground on a tricycle

  Change between 4 months of training (end of V3) and 6 months of training (end of V4)

• Change in Average Cycling-Speed in [km/h]

  Change in average speed during cycling over flat ground on a tricycle

  Change between 4 months of training (end of V3) and 6 months of training (end of V4)

• Change in Maximum Cycling-duration in [hh:mm:ss]

  Change in maximum duration during cycling over flat ground on a tricycle

  Change between 4 months of training (end of V3) and 6 months of training (end of V4)

• Change in Maximum Pedaling-Cadence in [RPM]

  Change in maximum pedaling-cadence during cycling over flat ground on a tricycle

  Change between 4 months of training (end of V3) and 6 months of training (end of V4)

• Change in Average Pedaling-Cadence in [RPM]

  Change in average pedaling-cadence during cycling over flat ground on a tricycle

  Change between 4 months of training (end of V3) and 6 months of training (end of V4)

• Ability to cycle 1200m in less than 8min

  Qualification criterion Cybathlon 2020. It will be assessed it the pilot is able to cycle 1200m in less than 8min over flat ground on a tricycle.

  After 6 months of training (end of V4)

Secondary Outcomes (18)

• Change of blood pressure during training

  through study completion (up to one year), an average throughout the study-duration

• Change of heart rate during training

  through study completion (up to one year), an average throughout the study-duration

• Maximum heart rate during training

  through study completion (up to one year), an average throughout the study-duration

• Average heart rate during training

  through study completion (up to one year), an average throughout the study-duration

• Cutaneous status

  through study completion (up to one year)

Study Arms (1)

Subjects

EXPERIMENTAL

Phase V1: 1 month of home-based FES-training using isometric contractions of quadriceps and hamstring muscles (3 times a week). Phase V2: 2 months of home-based FES-training on an ergo-cycle with arm support (3 times a week) Phase V3: 1 month of home-based FES-training on an ergo-cycle with arm support (1-2 times a week) and FES-cycling training overground on a tricycle (1-2 times a week) in the clinical setting. Optional (only for selected pilot): Phase V4: 2-4 months of home-based FES-training on an ergo-cycle with arm support (1-2 times a week) and FES-cycling training overground on a tricycle (1-2 times a week) in the clinical setting. This phase is focussing on optimizing the performance of the pilot and improving the mechanical efficiency of the tricycle. Phase V5: Participation on Cybathlon 2020

Device: Functional Electrical Stimulation

Interventions

Functional Electrical Stimulation DEVICE

Electrical stimulation of motor-nerves innervating the musculature of the lower limb.

Subjects

Eligibility Criteria

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

You may qualify if:

• informed written consent
• complete spinal cord injury AIS A or B
• neurological level of lesion C6 - T12
• post-lesion duration \> 12 moths
• paralysed muscles stimulable
• joints of lower limb freely moveable
• stable medical condition (absence of infectious respiratory or urinary event of cutaneous pathology confining the patient to bed and warranting treatment).

You may not qualify if:

• Not affiliated to a social security scheme, beneficiary or not such a plan
• Refusal to participate in the study (withdraw from study possible at any time)
• Inability to give consent
• body mass index higher or equal to 30
• flaccid paralysis (denervation)
• Inability to give consent
• neurogenic para-osteoarthropathy
• active thrombophlebitis
• muscular disease
• cardiovascular disease including coronary antecedent
• bone mineral density T-score below -2.5
• treatment with a drug known to have an effect on bone (\< 3 months)
• Aids in the lower limbs
• Epilepsy
• Orthostatic hypotension

Sponsors & Collaborators

• Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie: lead
• Institut National de Recherche en Informatique et en Automatique: collaborator
• Université Montpellier: collaborator

Study Sites (1)

Centre de Rééducation et de Réadaptation Fonctionnelle La Châtaigneraie

Menucourt, 95180, France

Location

Related Publications (1)

• Fattal C, Schmoll M, Le Guillou R, Raoult B, Frey A, Carlier R, Azevedo-Coste C. Benefits of 1-Yr Home Training With Functional Electrical Stimulation Cycling in Paraplegia During COVID-19 Crisis. Am J Phys Med Rehabil. 2021 Dec 1;100(12):1148-1151. doi: 10.1097/PHM.0000000000001898.

  PMID: 34596097 DERIVED

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 Design

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

Model Details: Training of paralysed musculature of the lower limb by using electrical stimulation.

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: June 2, 2020
• Study Start: October 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: September 1, 2020
• Last Updated: June 2, 2020

Record last verified: 2020-06

Locations

FR (1)