iCycle II: Recovery of Function Through FES Cycling With VR Biofeedback in People With SCI.

Rehabilitation
Standing/walking/mobility
Online since 5 November 2021, updated 837 days ago

About this trial

This trial is recruiting individuals with incomplete spinal cord injuries to test the effect of functional electrical stimulation (FES) leg cycling on walking function. Participants will receive FES to the legs while using a leg cycle (iCycle), operated from the user’s wheelchair. FES applies electrical stimulation through the skin activate weakened or paralyzed muscles. In this study, FES will assist leg cycling movements while participants compete in a virtual reality (VR) cycle race (a computer-generated experience similar to the real world, displayed on a monitor). Winning correlates with voluntary effort, thus researchers hope the iCycle motivates participants to increase intensity of exercise without additional demands on therapists’ time. If included, participants will receive FES supported leg cycling while they compete in a VR cycle race. There will be 8 weeks of baseline measurements, 12 weeks of training, and 8 weeks of follow-up. Final testing of motor function and walking will be performed at week 28.

Included participants

Gender
All
Age
≥ 18 years
Injury level
C1 - T11
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    ≥ 12 months
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-T11
    Additionally, participants must
    be 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)
    NOT have implanted device, e.g. pacemaker
    NOT have severe spasticity in lower limb muscle groups

    What’s involved

    Type

    Rehabilitation

    Details

    electrodes attached to the skin surface over specific leg muscles training sessions of leg cycling under the electrical stimulation for 20 min up to 1 hour assessments for a total of 28 weeks 8 weeks of baseline measurement 12 weeks of training (3 sessions/week, up to 1 hour per session) – participants will be asked if they wish to continue training after weeks 4 and 8 8 weeks of follow-up

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    General health

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 6 Jan 2022
    • Organisation
    • University College, London
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 6 Jan 2022
    • Organisation
    • University College, London

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more