Omnidirectional Virtual Reality and Treadmill TrainingTraditional Exercise
Omnidirectional Virtual Reality and Treadmill Training: Omni-VR forest scenario developed by our team involving real-life dual task walking and dynamic balance activities (ie. stepping over obstacles, and managing distractions) will be used for treatment group.
Traditional Exercise: A traditional exercise program including strengthening and unidirectional treadmill activities for the same duration will be completed in control group.
Study 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)
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Consent rate — Baseline Consent rate is the percentage of eligible individuals who participate. The investigators expect a consent rate of at least 40%.
Retention rate — 12 weeks (study completion) Retention rate is the percentage of participants who complete the 12-week intervention. The investigators expect a retention rate of 80% for the intervention group.
Usability of the Omnidirectional Treadmill and Virtual Reality Game — 12 weeks (study completion) Usability will be assessed by System Usability Scale (SUS) out of 100 points. The investigators expect a SUS score of 71 or higher among all participants.
Participant burden — Baseline and 12 weeks (study completion) Participant burden will be measured by the percentage of participants finishing assessments in 100 minutes or less. The investigators anticipate at least 85% of participants completing assessments within the time limit.
Adherence — 12 weeks (study completion) Adherence will be measured by the exercise session attendance. The investigators expect the treatment group to attend 70% or more of the sessions.
Equipment downtime — 12 weeks (study completion) The investigators will record any treadmill downtime due to VR technical issues. The targets are zero significant downtime in 85% of sessions.
Equipment safety — 12 weeks (study completion) The investigators will record any serious adverse events related to the study. The target is no serious adverse events related to the study
Trial sites (1)
Facility
City
Region
Status
Nova Scotia Rehabilitation & Arthritis Centre
Halifax
Nova Scotia
Recruiting
More Nova Scotia Health Authority trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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