Clinical trial NCT06495450: Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke
Official title: PROVE-VR: a Pilot Randomized Trial Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Virtual Reality
Stroke rehabilitation
Omnidirectional treadmill
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Brain Canada
First posted: 2024-07-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this pilot randomized controlled trial (RCT) is to test the feasibility (recruitment 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

Eligibility criteria: Inclusion Criteria:

* Stroke ≥ 6 months ago (per conventional stroke trials)
* Living within 50 km of Halifax, Nova Scotia
* Functional Ambulation Category ≥ 3
* Self-reported walking limitations (Walk-12 score \> 20)
* Ability to exercise for ≥ 15 minutes
* No visual deficits or hemispatial neglect
* No other cardiovascular, orthopedic, or neurological diseases impacting walking or balance
* Montreal Cognitive Assessment (MoCA) scores \> 18 indicating moderate or severe cognitive impairment

Primary outcomes:
measure: Recruitment rate
timeFrame: Baseline
measure: Retention rate
timeFrame: 12 weeks (study completion)
measure: Usability of the Omnidirectional Treadmill and Virtual Reality Game
timeFrame: 12 weeks (study completion)
measure: Participant burden
timeFrame: Baseline and 12 weeks (study completion)
measure: Adherence
timeFrame: 12 weeks (study completion)
measure: Equipment downtime
timeFrame: 12 weeks (study completion)
measure: Equipment safety
timeFrame: 12 weeks (study completion)
Secondary outcomes:
measure: Cognitive function
timeFrame: Baseline and 12 weeks (study completion)
measure: Brain activation in prefrontal and premotor cortices
timeFrame: Baseline and 12 weeks (study completion)
measure: Walking Speed
timeFrame: Baseline and 12 weeks (study completion)
measure: Step cadence
timeFrame: Baseline and 12 weeks (study completion)
measure: Step width
timeFrame: Baseline and 12 weeks (study completion)
measure: Step length
timeFrame: Baseline and 12 weeks (study completion)
measure: Dynamic balance
timeFrame: Baseline and 12 weeks (study completion)
Other outcomes:
measure: Motivation of participant
timeFrame: Baseline and 12 weeks (study completion)
measure: Health-related quality of life of participant
timeFrame: Baseline and 12 weeks (study completion)
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Rehabilitation & Arthritis Centre
state: Nova Scotia
Study officials:
References: