Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06495450 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke

Study acronym: PROVE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Aug 6, 2026 → Aug 6, 2027
See other at-risk trials from Nova Scotia Health Authority

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 6, 2026 to Aug 6, 2027 Show 4 more changesShow less
    • Study completion pushed from Sep 6, 2026 to Sep 6, 2027
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 4 of 9 entries
    • Site details revised
  2. Primary endpoints revised (7)
    • Eligibility criteria expanded, about 171 words
    • Secondary endpoints: 7 to 9
    v6
  3. Primary completion date: Aug 6, 2025 to Aug 6, 2026
    • Study completion date: Dec 6, 2025 to Sep 6, 2026
    v5
  4. Start date changed from estimate of Feb 28, 2025 to Apr 28, 2025v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 6, 2024 to Feb 28, 2025
    • Study sites: 0 to 1
    v3
  6. Secondary endpoints: details revised at 7 of 7 entriesv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT06495450
Lead Sponsor Nova Scotia Health Authority
Collaborators: Brain Canada
Conditions
(from sponsor)		 Stroke
Related terms Stroke
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov