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

NCT06419257 | Recruiting

• 1 other identifier: HS23059 (B2023:059)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advance Dementia

Outcome Measures

Primary Outcomes (1)

• Nurses overall observations of the study participants on a scale of -1, 0 and 1 for worse, no change and improved, respectively.

  a custom made questionnaire for interview of the nurses of the participants

  every week for a maximum of 52 weeks

Secondary Outcomes (1)

• The Game's score through the period of the study on a value between 0 to 100 for the minimum and maximum score in the game.

  every week for a maximum of 52 weeks

Study Arms (1)

VRDS users

EXPERIMENTAL

Individuals who would use the VRDS

Device: VRDS

Interventions

VRDS DEVICE

VRDS is an augmented virtual reality driving simulator.

VRDS users

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Living in a dementia care unit of Riverview Health Center
• Being mobile and able to see.

You may not qualify if:

• Residents with significant mobility issues (wheelchair users) and those with significant visual impairment will be excluded.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Riverview Health Center

Winnipeg, Manitoba, R3L 2P4, Canada

RECRUITING

Study Officials

• Zahra Moussavi

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zahra Moussavi, Ph.D.

CONTACT

2044747023; Zahra.Moussavi@umanitoba.ca

Saber Mirmiran, M.Sc.

CONTACT

mirmiras@myumanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: May 17, 2024
• Study Start: January 2, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

CA (1)