Recruiting

Omnidirectional Virtual Reality

Sponsor:

Nova Scotia Health Authority

Code:

NCT06495450

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Omnidirectional Virtual Reality and Treadmill Training

Traditional Exercise

Study Details

Brief 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)

Conditions

Stroke

Study ID

NCT06495450

Start date

Apr 28, 2025

Status verified date

Dec, 2025

Completion date

Sep 6, 2026

Anticipated

Primary completion date

Aug 6, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 the participant is able to walk with supervision or independently. This criterion was selected to ensure participants could safely participate in the intervention.
  • Ability to participate in low-moderate intensity aerobic or strengthening exercise for ≥ 15 minutes to ensure participants can tolerate intervention sessions of 30-45 minutes, with activity breaks, in keeping with previous stroke rehabilitation studies.
  • No uncorrected visual deficits or spatial neglect
  • No cardiovascular, orthopedic, or neurological diseases other than stroke impacting walking or balance
  • Can follow simple instructions
  • Score of < 27 on the adapted Motion Sickness Susceptibility Scale-Short based on established normative values indicating more than moderate susceptibility to motion sickness.

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 major program 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 2 treadmill)
  • Participating in another formal lower limb exercise program > 1 day per week
  • History of QT prolongation or using potential QT prolonging drugs

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Omni-VR group

20 participants will undergo 45-minute training sessions 3 times per week for 12 weeks using omnidirectional virtual reality and treadmill training.

active comparator: Control group

10 participants will undergo 45-minute traditional physiotherapy training sessions including lower limb strengthening and unidirectional treadmill training 3 times per week for 12 weeks.

Interventions

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.

Traditional Exercise

A traditional exercise program including strengthening and unidirectional treadmill activities for the same duration will be completed in control group.

Primary outcome measure

  • Consent rate [ Time Frame: Baseline ]
  • Retention rate [ Time Frame: 12 weeks (study completion) ]
  • Usability of the Omnidirectional Treadmill and Virtual Reality Game [ Time Frame: 12 weeks (study completion) ]
  • Participant burden [ Time Frame: Baseline and 12 weeks (study completion) ]
  • Adherence [ Time Frame: 12 weeks (study completion) ]
  • Equipment downtime [ Time Frame: 12 weeks (study completion) ]
  • Equipment safety [ Time Frame: 12 weeks (study completion) ]

Central Contacts and Locations

Central contacts

Adria Quigley, PhD

902-494-2734adriaquigley@dal.ca

Locations

Nova Scotia Rehabilitation & Arthritis Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 4K4

Contacts

Adria Quigley, PhD

902-494-2734adriaquigley@dal.ca

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Keywords

  • Virtual Reality
  • Stroke rehabilitation
  • Omnidirectional treadmill

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2025-12-16.