StrokePROVENCT06495450
Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke
A study testing Omnidirectional Virtual Reality and Treadmill Training and Traditional Exercise in people with Stroke, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Omnidirectional Virtual Reality and Treadmill Training and Traditional Exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 28 Apr 2025to 6 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Nova Scotia Rehabilitation & Arthritis Centre
Halifax, Nova Scotia, B3H 4K4
Adria Quigley, PhD, 902-494-2734, adriaquigley@dal.ca
About this study
Official title: PROVE-VR: A Pilot Randomized Trial Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke Survivors
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.
Read more
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)
Read the detailed description
Mounting data indicates that cognition plays a role in complex walking and balance. However, conventional intervention methods lack a sufficient incentive to encourage participants to adhere to the treatment. Further, it is difficult to provide a substantial amount of treatment to induce cortical reorganization.
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
- Stroke
- Being tested
- Omnidirectional Virtual Reality and Treadmill Training, Traditional Exercise
- Keywords
- Virtual Reality, Stroke rehabilitation, Omnidirectional treadmill
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnidirectional Virtual Reality and Treadmill TrainingDevice
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 ExerciseBehavioural
A traditional exercise program including strengthening and unidirectional treadmill activities for the same duration will be completed in control group.
| Study group | Role | What they receive |
|---|---|---|
| Omni-VR group | Experimental | 20 participants will undergo 45-minute training sessions 3 times per week for 12 weeks using omnidirectional virtual reality and treadmill training. Receives: Device: Omnidirectional Virtual Reality and Treadmill Training |
| Control group | Active comparator | 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. Receives: Behavioral: Traditional Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent rate
Consent rate is the percentage of eligible individuals who participate. The investigators expect a consent rate of at least 40%.
Measured: Baseline
Retention rate
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.
Measured: 12 weeks (study completion)
Usability of the Omnidirectional Treadmill and Virtual Reality Game
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.
Measured: 12 weeks (study completion)
Participant burden
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.
Measured: Baseline and 12 weeks (study completion)
Adherence
Adherence will be measured by the exercise session attendance. The investigators expect the treatment group to attend 70% or more of the sessions.
Measured: 12 weeks (study completion)
Equipment downtime
The investigators will record any treadmill downtime due to VR technical issues. The targets are zero significant downtime in 85% of sessions.
Measured: 12 weeks (study completion)
Equipment safety
The investigators will record any serious adverse events related to the study. The target is no serious adverse events related to the study
Measured: 12 weeks (study completion)
Secondary outcomes (9)
Cognitive function
The investigators will use the Computerized MoCA [Montreal Cognitive Assessment] Duo to evaluate participants' cognitive function.
Measured: Baseline and 12 weeks (study completion)
Executive Function
The investigators will use the Dimensional Change Card Sort to evaluate participants' executive function.
Measured: Baseline and 12 weeks (study completion)
Working memory
The investigators will use the List Sorting Working Memory Test to evaluate participants' working memory.
Measured: Baseline and 12 weeks (study completion)
Brain activation in prefrontal and premotor cortices
Brain activation using fNIRS [Functional near-infrared spectroscopy] in the prefrontal and premotor regions of interest during a single task (steady-state omnidirectional treadmill walking) and two cognitive-physical dual-task activities (simple dual-task: steady-state omnidirectional treadmill walking while repeating the same word and complex dual-task: steady-state omnidirectional treadmill walking while performing a verbal fluency test)
Measured: Baseline and 12 weeks (study completion)
Walking Speed
Walking speed using VIVE trackers on omnidirectional treadmill and overground
Measured: Baseline and 12 weeks (study completion)
Step cadence
The investigators will evaluate step cadence using the VIVE trackers.
Measured: Baseline and 12 weeks (study completion)
Step width
The investigators will evaluate step width using the VIVE trackers.
Measured: Baseline and 12 weeks (study completion)
Step length
The investigators will evaluate step length using the VIVE trackers.
Measured: Baseline and 12 weeks (study completion)
Dynamic balance
The investigators will measure the static sway with feet together using omni-VR system and use MINI-BESTest to measure the dynamic balance.
Measured: Baseline and 12 weeks (study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start28 Apr 2025
- Primary completion6 Aug 2027 (estimated)
- Study completion6 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Brain Canada
- Responsible party
- Principal investigator, Adria Quigley, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495450
- Sponsor's protocol ID
- PROVE_stroke
- Acronym
- PROVE
- Status last verified
- Oct 2026
- First submitted
- 20 Jun 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROVE-VR: A Pilot Randomized Trial Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke Survivors
- ClinicalTrials.gov ID
- NCT06495450
- Acronym / sponsor ID
- PROVE / PROVE_stroke
- Conditions
- Stroke
- Keywords
- Virtual Reality, Stroke rehabilitation, Omnidirectional treadmill
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Brain Canada
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 6 Aug 2027 (estimated)
- Study completion
- 6 Sep 2027 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
Mounting data indicates that cognition plays a role in complex walking and balance. However, conventional intervention methods lack a sufficient incentive to encourage participants to adhere to the treatment. Further, it is difficult to provide a substantial amount of treatment to induce cortical reorganization.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omni-VR group | Experimental | Device: Omnidirectional Virtual Reality and Treadmill Training20 participants will undergo 45-minute training sessions 3 times per week for 12 weeks using omnidirectional virtual reality and treadmill training. |
| Control group | Active comparator | Behavioral: Traditional Exercise10 participants will undergo 45-minute traditional physiotherapy training sessions including lower limb strengthening and unidirectional treadmill training 3 times per week for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omnidirectional Virtual Reality and Treadmill TrainingOmni-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. | Device | Omni-VR group |
| Traditional ExerciseA traditional exercise program including strengthening and unidirectional treadmill activities for the same duration will be completed in control group. | Behavioural | Control group |
Primary outcome
Consent rate
Time frame: Baseline
Consent rate is the percentage of eligible individuals who participate. The investigators expect a consent rate of at least 40%.
Retention rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
9 secondary outcomes
Cognitive function
Time frame: Baseline and 12 weeks (study completion)
Executive Function
Time frame: Baseline and 12 weeks (study completion)
Working memory
Time frame: Baseline and 12 weeks (study completion)
Brain activation in prefrontal and premotor cortices
Time frame: Baseline and 12 weeks (study completion)
Walking Speed
Time frame: Baseline and 12 weeks (study completion)
Step cadence
Time frame: Baseline and 12 weeks (study completion)
Step width
Time frame: Baseline and 12 weeks (study completion)
Step length
Time frame: Baseline and 12 weeks (study completion)
Dynamic balance
Time frame: Baseline and 12 weeks (study completion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omnidirectional Virtual Reality and Treadmill Training and Traditional Exercise in people with Stroke, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adria Quigley, PhD (902-494-2734, adriaquigley@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent rate (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.