Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke
NCT Number: NCT06495450
Acronym: PROVE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: DEVICE: Omnidirectional Virtual Reality and Treadmill Training|BEHAVIORAL: Traditional Exercise
Sponsor: Nova Scotia Health Authority
Collaborators: Brain Canada
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-06
Completion Date: 2025-12-06

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)

Primary Outcome Measures: Recruitment rate, Recruitment rate is the percentage of eligible individuals who participate. The investigators expect a recruitment rate of at least 40%., 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., 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., 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., 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., 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 participants., 12 weeks (study completion)|Equipment safety, The investigators will record any adverse events. The target is no serious adverse events., 12 weeks (study completion)
Secondary Outcome Measures: Cognitive function, The investigators will use the Computerized MoCA \[Montreal Cognitive Assessment\] Duo, the computerized Tower of London to evaluate participants' cognitive function., Baseline and 12 weeks (study completion)|Brain activation in prefrontal and premotor cortices, The investigators will examine brain activity in the prefrontal and premotor cortices using fNIRS \[Functional near-infrared spectroscopy\] during both single and dual-task scenarios., Baseline and 12 weeks (study completion)|Walking Speed, The investigators will evaluate walking speed through the omni-VR system., Baseline and 12 weeks (study completion)|Step cadence, The investigators will evaluate step cadence through the omni-VR system., Baseline and 12 weeks (study completion)|Step width, The investigators will evaluate step width through the omni-VR system., Baseline and 12 weeks (study completion)|Step length, The investigators will evaluate step length through the omni-VR system., 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., Baseline and 12 weeks (study completion)
Other Outcome Measures: Motivation of participant, The investigators will measure motivation by intrinsic motivation inventory. Higher scores indicate better results., Baseline and 12 weeks (study completion)|Health-related quality of life of participant, The investigators will measure health-related quality of life by SF-36 \[short-form 36\]. Higher scores indicate better results., Baseline and 12 weeks (study completion)