Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke

Last updated: December 9, 2025
Sponsor: Nova Scotia Health Authority
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Omnidirectional Virtual Reality and Treadmill Training

Traditional Exercise

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 (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)

Eligibility Criteria

Inclusion

Inclusion Criteria

  • 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 theparticipant is able to walk with supervision or independently. This criterion wasselected to ensure participants could safely participate in the intervention.

  • Ability to participate in low-moderate intensity aerobic or strengthening exercisefor ≥ 15 minutes to ensure participants can tolerate intervention sessions of 30-45minutes, with activity breaks, in keeping with previous stroke rehabilitationstudies.

  • No uncorrected visual deficits or spatial neglect

  • No cardiovascular, orthopedic, or neurological diseases other than stroke impactingwalking or balance

  • Can follow simple instructions

  • Score of < 27 on the adapted Motion Sickness Susceptibility Scale-Short based onestablished normative values indicating more than moderate susceptibility to motionsickness.

Exclusion

Exclusion Criteria:

  • 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 majorprogram modifications (e.g., chronic low back pain)

  • Serious comorbid condition that would affect participation in the intervention (e.g., active cancer, severe heart disease)

  • Severe loss of hearing or speech that would preclude VR use

  • Participant weight more than 264 lbs (weight limit for Virtualizer Elite 2treadmill)

  • Participating in another formal lower limb exercise program > 1 day per week

  • History of QT prolongation or using potential QT prolonging drugs

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Omnidirectional Virtual Reality and Treadmill Training
Phase:
Study Start date:
April 28, 2025
Estimated Completion Date:
September 06, 2026

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 6324729, Nova Scotia 6091530 B3H 4K4
    Canada

    Active - Recruiting

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