Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke

Last updated: June 20, 2025
Sponsor: Nova Scotia Health Authority
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Traditional Exercise

Omnidirectional Virtual Reality and Treadmill Training

Clinical Study ID

NCT06495450
PROVE_stroke
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Traditional Exercise
Phase:
Study Start date:
April 28, 2025
Estimated Completion Date:
December 06, 2025

Study 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

Connect with a study center

  • Nova Scotia Rehabilitation & Arthritis Centre

    Halifax, Nova Scotia B3H 4K4
    Canada

    Active - Recruiting

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