Improving function in people with spinal cord injuries using cycling and virtual reality.
Recovery of Function Through Cycling Therapy With Virtual Reality Biofeedback in Chronically Spinal Cord-injured People
This study is testing if combining cycling with virtual reality can help people with spinal cord injuries improve their walking ability and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University College, London Academic / other |
| Locations | 1 site (Stanmore, Middlesex) |
| Trial ID | NCT04902482 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a novel rehabilitation approach that combines functional electrical stimulation (FES) cycling with virtual reality (VR) biofeedback to enhance recovery in individuals with incomplete spinal cord injuries. Participants will engage in intensive cycling sessions over a 12-week period, with their performance linked to a competitive VR cycling game to encourage voluntary effort. The study aims to assess improvements in walking ability and overall quality of life, while also evaluating the feasibility of this cost-effective rehabilitation method. Outcome measures will be collected every four weeks to monitor progress and adjust the intervention as needed.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with incomplete spinal cord injuries above T12 who can respond to functional electrical stimulation.
Not a fit: Patients with severe comorbidities, cognitive difficulties, or those who do not meet the physical criteria for participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance mobility and independence for individuals with spinal cord injuries.
How similar studies have performed: Previous studies have shown promising results with similar rehabilitation techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>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 Criteria: * 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
Where this trial is running
Stanmore, Middlesex
- Royal National Orthopaedic Hospital — Stanmore, Middlesex, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.