Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke (NCT06495450) | Clinical Trial Compass
RecruitingNot Applicable
Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke
Canada30 participantsStarted 2025-04-28
Plain-language summary
The primary objective of this pilot randomized controlled trial (RCT) is to test the feasibility (consent rate, retention rate, participant burden, adherence, technical issues, safety) and usability (system usability scale, SUS) of Omnidirectional treadmill Virtual Reality training (omni-VR) among chronic stroke survivors. Our secondary objective is to (1) estimate the extent to which cognition, brain activation during a dual task activity, walking ability, and dynamic balance change after 3 months of training among intervention participants (omni-VR) and traditional exercise controls, and (2) estimate the extent to which health-related quality of life and motivation co-evolve with our secondary outcomes.
Researchers will compare the intervention group and control group to evaluate the impact of omni-VR on cognition and physical function among stroke survivors.
Participants will:
* undergo a 45-minute training session 3 times per week for 12 weeks
* intervention group: omni-VR
* control group: traditional exercise program (strengthening and walking activities)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 th…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Consent rate
Timeframe: Baseline
2
Retention rate
Timeframe: 12 weeks (study completion)
3
Usability of the Omnidirectional Treadmill and Virtual Reality Game
Timeframe: 12 weeks (study completion)
4
Participant burden
Timeframe: Baseline and 12 weeks (study completion)