NCT06495450

Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke

PROVE-VR: A Pilot Randomized Trial Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke Survivors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Nova Scotia Health Authority · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

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

Interventions

Type	Name	Description
DEVICE	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.
BEHAVIORAL	Traditional Exercise	A traditional exercise program including strengthening and unidirectional treadmill activities for the same duration will be completed in control group.

Timeline

• Start date: 2025-04-28
• Primary completion: 2026-08-06
• Completion: 2026-09-06
• First posted: 2024-07-10
• Last updated: 2025-12-16

Locations

1 site across 1 country: Canada