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Investigating the Efficacy of an Augmented Virtual Reality Driving Simulator on Institutionalized Dementia Patients

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 10 months later Jun 2026 → May 2027
See other at-risk trials from University of Manitoba

Record History

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  1. Notable Primary completion pushed from Jun 2026 to May 2027
    • Study completion pushed from Jun 2026 to Jun 2027
    • Secondary endpoints: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 3 words
  2. Notable Primary and study completion dates: Jun 30, 2025 to Jun 2026v3
  3. Notable Primary completion date: Dec 31, 2024 to Jun 30, 2025v2
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
1,978 trials monitored
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The improvement in health and welfare in modern society has led to an increase in life expectancy. Alternatively, the longer one lives, the more likely to experience deterioration in memory, cognitive ability, and executive function skills in our brains. While some cognitive impairments can be typical results of normal aging, a decline in spatial cognition can be a sign of dementia, especially Alzheimer's disease (AD). Based on the neuroplasticity of the brain even at old ages, there are some hopes to combat dementia by repeated use of cognitive exercises in the form of a serious game designed for older adults. A popular new technology to be used to design serious games is virtual reality (VR) designs. Aside from the gaming applications, the focus of VR experiments in medicine and neuroscience is to simulate a naturalistic environment to investigate brain function and/or use it for cognitive training. A virtual reality driving simulator (VRDS) has been developed by our team that is proposed to be installed in an existing car model at Riverview Health Center (RHC) dementia units. The VRDS has different levels of difficulty so that it can be utilized by people with different levels of cognitive impairments. However, in this study, the users will probably use only its level 1. The aim is to investigate the efficacy of the VRDS amongst institutionalized Alzheimer's/dementia patients, who are not capable of performing standard assessments. The goal is mainly to improve their mood and quality of life as many of these patients miss driving. Thus, their plausible mood change are assessed by asking the dementia unit nurses to share their observations of the patients in relation to VRDS usage; it will be a free-format anecdotal observation. In addition, while these patients are not expected to show any significant learning, playing this VRDS may improve patients' implicit memory; which can be observed by how well or poor they drive the simulated car; for example, how many times they crash to the curb or how many times they hit an animal, or how many times they ignore the red traffic light, etc.; these are reflected in the game's score. It is anticipated that this VRDS will have an overall positive effect on users' moods, and also it may result in an implicit memory improvement.
Trial Details
NCT Number NCT06419257
Lead Sponsor University of Manitoba
Conditions
(from sponsor)
Advance Dementia
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov