Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke
NCT ID: NCT06495450
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-04-28
2026-09-06
Brief Summary
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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)
Detailed Description
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Virtual reality or VR (a computer-generated simulation of 3-dimensional virtual environments that reacts in real time to the user's actions) has been introduced to neurorehabilitation to promote improvements in walking ability, balance, and cognition. It has also been demonstrated to be effective in improving motivation among stroke survivors and augmenting neuroplasticity.
Omnidirectional treadmill technology can be integrated with VR to allow for fully immersive rehabilitation. This novel and innovative technology mimics real-world environments and maximizes challenging cognitive and physical dual-tasking and balance activities while maintaining patient safety. However, no randomized trials have evaluated the impact of omnidirectional treadmill VR (Omni-VR) on cognitive and physical function among stroke survivors.
Therefore, our study aims to test the feasibility and usability of the Omni-VR. This pilot randomized control trial will also be the first study to test the feasibility and effect of a fully-immersive active omni-VR system among chronic stroke survivors
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Omni-VR group
20 participants will undergo 45-minute training sessions 3 times per week for 12 weeks using omnidirectional virtual reality and treadmill training.
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.
Control group
10 participants will undergo 45-minute traditional physiotherapy training sessions including lower limb strengthening and unidirectional treadmill training 3 times per week for 12 weeks.
Traditional Exercise
A traditional exercise program including strengthening and unidirectional treadmill activities for the same duration will be completed in control group.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Brain Canada
OTHER
Nova Scotia Health Authority
OTHER
Responsible Party
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Adria Quigley
Assistant Professor
Locations
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Nova Scotia Rehabilitation & Arthritis Centre
Halifax, Nova Scotia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PROVE_stroke
Identifier Type: -
Identifier Source: org_study_id