Spinal Cord Injuries Clinical Trial
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
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06321172 -
Muscle and Bone Changes After 6 Months of FES Cycling
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05484557 -
Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury
|
N/A | |
Suspended |
NCT05542238 -
The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury
|
N/A | |
Recruiting |
NCT05503316 -
The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System
|
N/A | |
Not yet recruiting |
NCT05506657 -
Early Intervention to Promote Return to Work for People With Spinal Cord Injury
|
N/A | |
Recruiting |
NCT04105114 -
Transformation of Paralysis to Stepping
|
Early Phase 1 | |
Recruiting |
NCT03680872 -
Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System
|
N/A | |
Completed |
NCT04221373 -
Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation
|
N/A | |
Completed |
NCT00116337 -
Spinal Cord Stimulation to Restore Cough
|
N/A | |
Completed |
NCT03898700 -
Coaching for Caregivers of Children With Spinal Cord Injury
|
N/A | |
Recruiting |
NCT04883463 -
Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury
|
N/A | |
Active, not recruiting |
NCT04881565 -
Losing Balance to Prevent Falls After Spinal Cord Injury (RBT+FES)
|
N/A | |
Completed |
NCT04864262 -
Photovoice for Spinal Cord Injury to Prevent Falls
|
N/A | |
Recruiting |
NCT04007380 -
Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI
|
N/A | |
Active, not recruiting |
NCT04544761 -
Resilience in Persons Following Spinal Cord Injury
|
||
Completed |
NCT03220451 -
Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients
|
N/A | |
Terminated |
NCT03170557 -
Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation
|
N/A | |
Recruiting |
NCT04811235 -
Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial
|
N/A | |
Recruiting |
NCT04736849 -
Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury
|
N/A |