iCycle II

  • Research type

    Research Study

  • Full title

    iCycle II: Recovery of function through cycling therapy with virtual reality biofeedback in chronically spinal cord-injured people

  • IRAS ID

    286353

  • Contact name

    Lynsey Duffell

  • Contact email

    l.duffell@ucl.ac.uk

  • Sponsor organisation

    University College London

  • Clinicaltrials.gov Identifier

    NCT04902482

  • Clinicaltrials.gov Identifier

    Z6364106/2021/06/12, Data Protection Registration

  • Duration of Study in the UK

    1 years, 5 months, 30 days

  • Research summary

    The annual incidence of traumatic spinal cord injury 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 injuries, with significant potential for neurological improvement. Discovering ways to provide intensive, but cost-effective Spinal Cord Injury (SCI) rehabilitation is therefore increasingly important.
    The iCycle combines Functional Electrical Stimulation (FES) cycling with Virtual Reality (VR) cycle-racing feedback, where winning correlates with voluntary effort, to promote recovery. The aim is to improve walking in people with incomplete injuries, fundamental to independence and quality of life as well as long-term health. We know that more intensive rehabilitative training leads to better outcomes: the iCycle has the potential to increase intensity of exercise without additional demands on therapists’ time and therefore cost.
    Following the encouraging results in our first study; it is now important for us to find out whether recovery will continue at a similar rate if iCycle training continues beyond 4 weeks. We will offer six volunteers with SCI to participate in this 28 week, single-site open feasibility trial. The intervention phase will be for up to 12 weeks (3 sessions per week), with outcome measures (ISNC-SCI motor scoring, Trunk Impairment scale, Walking Index for Spinal Cord Injury, 6-minute walk test and Goal Attainment Scale) taken every 4 weeks and fed back to the participants. Each participant may then decide, at the end of each 4-week period, whether or not they wish to continue training, up to 12 weeks. In addition, neural conductivity will be assessed (using TMS) to provide preliminary evidence of the mechanisms underlying any observed neurological and functional recovery.

  • REC name

    West Midlands - Edgbaston Research Ethics Committee

  • REC reference

    21/WM/0173

  • Date of REC Opinion

    1 Sep 2021

  • REC opinion

    Further Information Favourable Opinion