Status:
RECRUITING
Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke
Lead Sponsor:
Nova Scotia Health Authority
Collaborating Sponsors:
Brain Canada
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
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 (...
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 tr...
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 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
Exclusion
Key Trial Info
Start Date :
April 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 6 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06495450
Start Date
April 28 2025
End Date
September 6 2026
Last Update
December 16 2025
Active Locations (1)
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1
Nova Scotia Rehabilitation & Arthritis Centre
Halifax, Nova Scotia, Canada, B3H 4K4