Clinical trial NCT04412447: Training for Persons With Complete SCI for FES Cycling: a Case Series
Official title: Training of Persons With Complete Spinal Cord Injury for Pedaling on a Tricycle, Induced by Electrical Stimulation of the Paralysed Muscles: a Case Series
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche en Informatique et en Automatique
name: Université Montpellier
First posted: 2020-06-02
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Training of paralysed musculature of the lower limb by using electrical stimulation.
Primary purpose: BASIC_SCIENCE

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.

Detailed description: People with spinal cord injuries suffer from numerous comorbidities, linked in particular to immobility and sedentariness. Studies have shown the benefits of training and reconditioning to adapted effort in spinal cord injured people. Among other innovative techniques, functional electrical stimulation (FES) is aimed primarily at mobilizing as many muscles as possible. Concerning electro-stimulated pedaling on a tricycle, it would allow individuals with paraplegia or tetraplegia to practise physical activity in perspective of experiencing pleasure during training.

In 2016, our team carried out a pilot study aiming at using a recumbent tricylce powered by the lower limbs of a person with complete paraplegia under electrostimulation. The participant was trained for 12 months, whit the objective to participate at an international competition (Cybathlon 2016). This first study has opened up prospects and identified avenues for improvement.

The main objective of this study is to significantly improve, over a limited period of time, the pedalling performance on a tricycle by using electrical stimulation of the sub-lesional muscles of people with spinal cord injuries. Secondary focusses will be: physical and psychological tolerance to training; influence on pain, cardio-respiratory functions, body composition regarding muscle trophicity and bone metabolism; psycho-social impact; impact of modification of stimulation parameters (frequency, phase width, intensity, waveform, contact location) in performance optimization and delay of muscle fatigue; performance impact of mechanical modifications performed on the tricycle.

This is a prospective case study: patients suffering from a complete traumatic injury and followed at the Centre de Rééducation et de Réadaptation Fonctionnelle (CRRF) La Châtaigneraie (Menucourt) will be recruited by the investigating physician during a consultation for a period of approximately 6 months. The centre specialised in the management of acute and chronic neurological lesions. The eligibility criteria are predefined to ensure the participants safety. After verification of the criteria and before the start of the programme, an exercise test (monitoring of the evolution of VO2max) will be carried out in the Sports Medicine department of the CHI of Saint-Germain-en-Laye. The first phase (V1) consists of a one-month home-based isometric muscle training programme by electrostimulation followed by a two-month programme (phase V2) of home-based muscle training by electrostimulation on an ergocycle including one training per week at the CRRF. The home ergocycle electro-stimulation muscle training, will be continued once or twice a week and complemented in the third phase (V3) by training at the CRRF on a tricycle for one month. Only the patient selected to participate in the Cybathlon 2020 will continue with the final phase (V4), which includes, over a period of 2 to 4 months, muscle training by electrostimulation on an ergocycle at home, electrostimulation sessions on a tricycle up to 3 times a week at the CRRF. In this phase, the optimization of the stimulation and electrical patterns and the mechanics of the tricycle will take place in order to maximize the pilots overall performance. Finally, the pilot will take part in the tricycle FES-Cycling race at the Cybathlon 2020 in Zurich, i.e. an international competition and technological challenge, requiring to master 1200 metres in a maximum time of 8 minutes. The different training programs are based on sport-scientific principles and a physiotherapist will follow up on the home sessions. The collaborating teams (engineers and researchers from INRIA, the French National Institute for Research in Computer Science and Control) will measure performance in a bimonthly frequency.

This research should demonstrate that the safety, acceptability, satisfaction, self-esteem and quality of life induced by the practice of FES-assisted pedalling, opens a new way of training in rehabilitation centres and at home with the perspective of improving certain physiological functions in the long-term.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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
* Fractures of the lower limbs older (\< 12 months)
* Pacemakers or other implants contraindicating the use of FES
* Pregnancy (women)

Primary outcomes:
measure: Change in Maximum Cycling-Distance in [m]
timeFrame: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
measure: Change in Maximum Cycling-Speed in [km/h]
timeFrame: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
measure: Change in Average Cycling-Speed in [km/h]
timeFrame: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
measure: Change in Maximum Cycling-duration in [hh:mm:ss]
timeFrame: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
measure: Change in Maximum Pedaling-Cadence in [RPM]
timeFrame: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
measure: Change in Average Pedaling-Cadence in [RPM]
timeFrame: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
measure: Ability to cycle 1200m in less than 8min
timeFrame: After 6 months of training (end of V4)
Secondary outcomes:
measure: Change of blood pressure during training
timeFrame: through study completion (up to one year), an average throughout the study-duration
measure: Change of heart rate during training
timeFrame: through study completion (up to one year), an average throughout the study-duration
measure: Maximum heart rate during training
timeFrame: through study completion (up to one year), an average throughout the study-duration
measure: Average heart rate during training
timeFrame: through study completion (up to one year), an average throughout the study-duration
measure: Cutaneous status
timeFrame: through study completion (up to one year)
measure: Musculo-skeletal pain or inflammation
timeFrame: through study completion (up to one year)
measure: Psychological: Satisfaction
timeFrame: through study completion (up to one year), an average throughout the study-duration
measure: Psychological: Acceptability
timeFrame: through study completion (up to one year), every 30 days
measure: General Fatigue
timeFrame: through study completion (up to one year), an average throughout the study-duration
measure: Psycho-Social: Self-Esteem
timeFrame: through study completion (up to one year), every 15 days
measure: Psycho-Social: Quality of Life
timeFrame: through study completion (up to one year), every 30 days
measure: Cardio-Respiratory Fitness: Maximal Heartrate
timeFrame: Change between timepoint before first training, after 4 months of training (end of V3) and after 6 months of training (end of V4)
measure: Cardio-Respiratory Fitness: VO2max
timeFrame: Change between timepoint before first training, after 4 months of training (end of V3) and after 6 months of training (end of V4)
measure: Musculo-skeletal changes: Thigh perimeter
timeFrame: Change between timepoint before first training and after end of study (end of V5, ~ 7 months)
measure: Musculo-skeletal changes: Bone mineral density
timeFrame: Change between timepoint before first training and after end of study (end of V5, ~ 7 months)
measure: Musculo-skeletal changes: Body composition
timeFrame: Change between timepoint before first training and after end of study (end of V5, ~ 7 months)
measure: Occurrence of spasms: before training
timeFrame: through study completion (up to one year), an average throughout the study-duration
measure: Occurrence of spasms : after training
timeFrame: through study completion (up to one year), an average throughout the study-duration
Other outcomes:
Locations:
city: Menucourt
country: France
facility: Centre de Rééducation et de Réadaptation Fonctionnelle La Châtaigneraie
Study officials:
References:
citation: 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.