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

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Nova Scotia Rehabilitation & Arthritis Centre
RECRUITING
Halifax
Contact Information
Primary
Adria Quigley, PhD
adriaquigley@dal.ca
902-494-2734
Time Frame
Start Date: 2025-04-28
Estimated Completion Date: 2026-09-06
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Nova Scotia Health Authority
Collaborators: Brain Canada

This content was sourced from clinicaltrials.gov