RecruitingNot ApplicableNCT04902482

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

Recovery of Function Through Cycling Therapy With Virtual Reality Biofeedback in Chronically Spinal Cord-injured People


Sponsor

University College, London

Enrollment

6 participants

Start Date

Jan 6, 2022

Study Type

INTERVENTIONAL

Conditions

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 injuries, with significant potential for neurological improvement. Discovering ways to provide intensive, but cost-effective SCI rehabilitation is therefore increasingly important. The iCycle combines functional electrical stimulation (FES) cycling with 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. More intensive rehabilitative training is associated with 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 an initial study; it is now important to find out whether recovery will continue at a similar rate if iCycle training continues beyond 4 weeks. Six volunteers with SCI will be recruited to participate in this 20 week, single-site open feasibility trial. The trial consists of an intervention phase lasting up to 12 weeks (3 iCycle sessions per week), and an 8-week follow-up phase. Outcome measures (ISNC-SCI motor scoring, Trunk Impairment scale, Walking Index for Spinal Cord Injury, 6-minute walk test, Goal Attainment Scale and TMS) will be taken every 4 weeks. The 12-week intervention phase will be separated into three 4-week blocks; at the end of each block participants may decide whether or not they wish to continue training.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • >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 Criteria16

  • 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

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Interventions

DEVICEiCycle Mark 3

The iCycle Mark 3 is a cycle ergometer, designed to be used by people with SCI while they are seated in their own wheelchairs. The purpose of iCycle is to stimulate the leg muscles in the correct phase for cycling while motivating the person with a Virtual Reality cycling event, perhaps a race, to try to use their muscles.


Locations(1)

Royal National Orthopaedic Hospital

Stanmore, Middlesex, United Kingdom

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NCT04902482


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