Status:
RECRUITING
iCycle II: Recovery of Function Through FES Cycling With VR Biofeedback in People With SCI.
Lead Sponsor:
University College, London
Collaborating Sponsors:
University of Southampton
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The annual incidence of traumatic spinal cord injury (SCI) is estimated at 2,500 (35 per week) in the UK and, due to advances in research and clinical management, the majority now have incomplete inju...
Detailed Description
Recruitment: Participants will be recruited from London Spinal Cord injuries Centre (LSCIC) at the Royal National Orthopaedic Hospital (RNOH) where the training intervention will be carried out. The ...
Eligibility Criteria
Inclusion
- \>18 years
- Incomplete SCI above T12
- \>12 months post injury
- Respond to FES
- No deteriorating condition or other co-morbidity that would make participation impractical or unsafe.
- Marginal walker defined as able to rise from a chair, stand for 10 seconds and walk \>10 steps without human help (but may use an aid including parallel bars).
Exclusion
- Cardiac pacemaker
- Pressure sores/skin problems
- Unhealed lower limb fractures
- Pregnancy
- Active heterotrophic ossification - lower limbs
- Severe osteoporosis
- Complex regional pain syndrome
- Implanted metal work at electrode site (\< 3/12)
- Lower Limb Malignancy
- T6 and below spinal malignancy
- Uncontrolled autonomic dysreflexia
- History of knee dislocation/subluxation
- Allergy to electrodes
- Cognitive difficulties - must be able to demonstrate an understanding of the iCycle and the virtual reality cycling game
- Severe spasticity - Ashworth scale 4 or 5 in any lower limb muscle groups
- Neurological degenerative diseases
Key Trial Info
Start Date :
January 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04902482
Start Date
January 6 2022
End Date
November 30 2024
Last Update
April 26 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal National Orthopaedic Hospital
Stanmore, Middlesex, United Kingdom, HA74LP