Using virtual reality and treadmill training for stroke rehabilitation
PROVE-VR: A Pilot Randomized Trial Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke Survivors
NA · Nova Scotia Health Authority · NCT06495450
This study is testing whether using virtual reality along with treadmill training can help stroke survivors improve their walking, balance, and overall quality of life better than regular exercise.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nova Scotia Health Authority (other) |
| Locations | 1 site (Halifax, Nova Scotia) |
| Trial ID | NCT06495450 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial aims to evaluate the feasibility and usability of Omnidirectional Virtual Reality (omni-VR) combined with treadmill training for chronic stroke survivors. Participants will engage in 45-minute training sessions three times a week for 12 weeks, comparing the effects of omni-VR on cognition, walking ability, and balance against traditional exercise methods. The study will also assess the impact on health-related quality of life and motivation. By integrating immersive VR technology with treadmill training, the research seeks to enhance rehabilitation outcomes for stroke survivors.
Who should consider this trial
Good fit: Ideal candidates are chronic stroke survivors who have experienced a stroke at least six months prior and have moderate to severe cognitive impairment.
Not a fit: Patients with other cardiovascular, orthopedic, or neurological diseases affecting walking or balance may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve cognitive and physical rehabilitation outcomes for stroke survivors.
How similar studies have performed: While the use of virtual reality in rehabilitation has shown promise, this specific approach using omnidirectional treadmill VR is novel and has not been previously tested in randomized trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Age ≥ 18 * Stroke ≥ 6 months ago (confirmed with chart review) * Living within 50 km of Halifax, Nova Scotia * Functional Ambulation Category of 3 or greater on a scale of 0-5, to ensure the participant is able to walk with supervision or independently. This criterion was selected to ensure participants could safely participate in the intervention. * Ability to participate in low-moderate intensity aerobic or strengthening exercise for ≥ 15 minutes to ensure participants can tolerate intervention sessions of 30-45 minutes, with activity breaks, in keeping with previous stroke rehabilitation studies. * No uncorrected visual deficits or spatial neglect * No cardiovascular, orthopedic, or neurological diseases other than stroke impacting walking or balance * Can follow simple instructions * Score of \< 27 on the adapted Motion Sickness Susceptibility Scale-Short based on established normative values indicating more than moderate susceptibility to motion sickness. Exclusion Criteria: * Unstable serious medical condition * Resting blood pressure \>180/100mmHg * History of abnormal untreated heart rhythm * Pregnancy * Condition limiting ability to complete or tolerate the exercises without major program modifications (e.g., chronic low back pain) * Serious comorbid condition that would affect participation in the intervention (e.g., active cancer, severe heart disease) * Severe loss of hearing or speech that would preclude VR use * Participant weight more than 264 lbs (weight limit for Virtualizer Elite 2 treadmill) * Participating in another formal lower limb exercise program \> 1 day per week * History of QT prolongation or using potential QT prolonging drugs
Where this trial is running
Halifax, Nova Scotia
- Nova Scotia Rehabilitation & Arthritis Centre — Halifax, Nova Scotia, Canada (RECRUITING)
Study contacts
- Study coordinator: Adria Quigley, PhD
- Email: adriaquigley@dal.ca
- Phone: 902-494-2734
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.
Conditions: Stroke, Virtual Reality, Stroke rehabilitation, Omnidirectional treadmill