Status:
UNKNOWN
Training for Persons With Complete SCI for FES Cycling: a Case Series
Lead Sponsor:
Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie
Collaborating Sponsors:
Institut National de Recherche en Informatique et en Automatique
Université Montpellier
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-65 years
Phase:
NA
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 incr...
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 eff...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04412447
Start Date
October 1 2019
End Date
September 1 2020
Last Update
June 2 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre de Rééducation et de Réadaptation Fonctionnelle La Châtaigneraie
Menucourt, France, 95180