Virtual Reality Driving Simulator for Dementia

Overseen By Saber Mirmiran, M.Sc.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Disqualifiers: Significant mobility issues, visual impairment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a virtual reality driving simulator to improve mood and quality of life, so it's unlikely that medication changes are required.

What data supports the effectiveness of the treatment Augmented Virtual Reality Driving Simulator, Virtual Reality Driving Simulator, VRDS for dementia?

Research shows that using a virtual reality driving simulator can improve spatial cognition (the ability to understand and remember the spatial relations among objects) and mood in older adults with dementia. Participants in a study showed a 44.4% improvement in finding targets in a virtual test after using the simulator, and they also reported better mood. ^{1 2 3 4 5}

Is the Virtual Reality Driving Simulator safe for humans?

Driving simulators, including virtual reality ones, are generally considered safe for humans, though some people may experience simulator sickness (a feeling of nausea or dizziness). Management strategies exist to reduce or prevent this issue. ^{6 7 8 9 10}

How does the Virtual Reality Driving Simulator treatment differ from other treatments for dementia?

The Virtual Reality Driving Simulator (VRDS) is unique because it uses virtual reality technology to improve spatial cognition and mood in people with dementia, offering a non-drug approach that combines cognitive training with an engaging, interactive experience. Unlike traditional treatments, VRDS provides a safe and controlled environment to practice driving skills and assess functional behavior, potentially enhancing quality of life without the side effects associated with medications. ^{1 3 4 9 11}

Research Team

Zahra Moussavi

Principal Investigator

University of Manitoba

Eligibility Criteria

This trial is for institutionalized dementia patients, particularly those who cannot perform standard assessments. It aims to improve their mood and quality of life by using a virtual reality driving simulator (VRDS). The study seeks individuals with varying levels of cognitive impairment but will likely use the easiest level of the VRDS.

Inclusion Criteria

Living in a dementia care unit of Riverview Health Center

I can move around and see.

Exclusion Criteria

I do not use a wheelchair for mobility.

I do not have significant visual impairment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

VRDS Training

Participants use the Virtual Reality Driving Simulator (VRDS) to improve mood and implicit memory

52 weeks

Weekly sessions

Follow-up

Participants are monitored for mood and implicit memory improvements through nurse observations and game scores

4 weeks

Treatment Details

Interventions

• Augmented Virtual Reality Driving Simulator

Trial Overview The trial is testing whether a VR driving simulator can enhance mood and implicit memory in dementia patients. Nurses at Riverview Health Center will observe changes in patient behavior, while game scores will indicate potential improvements in memory based on driving performance.

Participant Groups

Group I: VRDS users Experimental Treatment 1 Intervention

Individuals who would use the VRDS

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Findings from Research

A virtual reality driving simulator (VRDS) was tested on 11 participants with varying levels of dementia over 10 sessions, showing a significant 44.4% improvement in spatial cognition as measured by the Morris Water test after the intervention.

Participants not only improved their spatial skills but also progressed to more challenging levels of the game and reported better mood, suggesting that regular use of the VRDS could be beneficial for older adults with cognitive impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Practicing with a Virtual Reality Driving Simulator Improve Spatial Cognition in Older Adults? A Pilot Study. Masoumzadeh, S., Moussavi, Z.[2022]

Virtual reality (VR) interventions are primarily used in dementia education and training, showing potential to enhance health professionals' and trainees' knowledge, attitudes, empathy, and sensitivity towards dementia care.

Despite the promising results, the evidence is not yet robust enough to fully endorse the use of immersive virtual learning in dementia training, highlighting the need for more rigorous studies with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of virtual and augmented reality-based interventions in health education to improve dementia knowledge and attitudes: an integrative review. Jones, C., Jones, D., Moro, C.[2021]

A scoping review of 19 studies found that Virtual Reality (VR) technologies can positively impact the emotional wellbeing of persons with dementia, with emotional outcomes being the primary focus in 89.5% of the studies.

While VR shows promise in enhancing quality of life for people with dementia, there is a need for further exploration of its effects on social engagement and personhood, as well as customization of VR tools for different sub-groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality to promote wellbeing in persons with dementia: A scoping review. Appel, L., Ali, S., Narag, T., et al.[2022]

The study involving six persons with dementia showed that they could effectively interact with a virtual reality environment, indicating that VR can be a useful tool for assessing functional behavior in a realistic setting.

Participants did not experience significant simulator sickness or negative impacts on their psychological and physical well-being, suggesting that VR technology is safe for use among individuals with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a virtual reality-based methodology for people with dementia: a feasibility study. Flynn, D., van Schaik, P., Blackman, T., et al.[2019]

A pilot tool for dementia screening using virtual reality (VR) and augmented reality (AR) was developed, showing that it can effectively assess cognitive function in a way that engages participants emotionally.

In a study with 24 middle-aged participants, the VR/AR screening tool (VSIDCS) produced test scores consistent with traditional assessments like MoCA and MMSE, while also enhancing participant involvement and positive experiences during the testing process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Tool of the Virtual Scenario Initial Dementia Cognitive Screening (VSIDCS) with a Cultural Exhibition for Improving the Standard Traditional Test. Liu, CL., Chang, SR.[2021]

In a study of 114 older adults, those who performed poorly in a low-fidelity driving simulator were more likely to be involved in accidents where they were at least partially at fault over a subsequent 5-year period.

This suggests that even basic driving simulators can be effective tools for predicting real-world driving safety outcomes, highlighting their potential use in assessing driving capabilities in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulator driving performance predicts accident reports five years later. Hoffman, L., McDowd, JM.[2015]

Driving simulation technology is a safe and effective tool for occupational therapy practitioners to assess driving performance, helping to identify impairments and errors in at-risk drivers based on a review of existing literature.

While simulator sickness can be a limitation, strategies exist to manage it, and further empirical research is needed to establish driving simulators as a reliable and cost-effective clinical tool for driving assessment and intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Driving simulators for occupational therapy screening, assessment, and intervention. Classen, S., Brooks, J.[2014]

Augmented reality (AR) cues significantly improved the ability of middle-aged and older drivers with cognitive impairments to judge safe left-turns across oncoming traffic, as evidenced by shorter estimated Time-to-Contact (TTC) and increased response rates in cued conditions.

Drivers reported that the AR cues were not distracting, and those with the greatest cognitive decline adjusted their driving behavior to align more closely with that of middle-aged drivers, indicating that AR technology can enhance driving safety without causing additional distractions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmented reality cues to assist older drivers with gap estimation for left-turns. Rusch, ML., Schall, MC., Lee, JD., et al.[2021]

The study involving 91 neurological patients demonstrated that driving simulators can effectively differentiate between fit and unfit drivers based on reaction times and driving behaviors across various environments, highlighting their potential as assessment tools.

Unfit drivers showed significant issues such as greater variability in steering and more collisions in urban settings, while conditionally fit drivers did not exhibit clear differences from fit drivers, indicating the need for careful human judgment in their evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring driving characteristics of fit- and unfit-to-drive neurological patients: a driving simulator study. Motnikar, L., Stojmenova, K., Štaba, UČ., et al.[2020]

The study utilized the Iowa Driving Simulator to analyze crashes involving drivers with Alzheimer disease (AD), revealing specific safety errors that lead to accidents, such as inappropriate responses with hand and foot controls and failure to respond altogether.

By graphically dissecting the moments leading up to crashes, the research provides insights into the driving behaviors of AD patients, which can inform future strategies for preventing accidents and improving driver safety in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Driving with Alzheimer disease: the anatomy of a crash. Reinach, SJ., Rizzo, M., McGehee, DV.[2007]

Driving simulators can be valuable tools for assessing the driving abilities of individuals with dementia, helping to predict their future driving safety.

The review highlights the strengths and weaknesses of different types of simulators, emphasizing the need for appropriate use in evaluating driving capabilities in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulators for assessing driving skills in demented patients. Bylsma, FW.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Does Practicing with a Virtual Reality Driving Simulator Improve Spatial Cognition in Older Adults? A Pilot Study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Use of virtual and augmented reality-based interventions in health education to improve dementia knowledge and attitudes: an integrative review. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Virtual reality to promote wellbeing in persons with dementia: A scoping review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Developing a virtual reality-based methodology for people with dementia: a feasibility study. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A Pilot Tool of the Virtual Scenario Initial Dementia Cognitive Screening (VSIDCS) with a Cultural Exhibition for Improving the Standard Traditional Test. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Simulator driving performance predicts accident reports five years later. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Driving simulators for occupational therapy screening, assessment, and intervention. [2014]

8. England pubmed.ncbi.nlm.nih.gov

Augmented reality cues to assist older drivers with gap estimation for left-turns. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Exploring driving characteristics of fit- and unfit-to-drive neurological patients: a driving simulator study. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Driving with Alzheimer disease: the anatomy of a crash. [2007]

11. United States pubmed.ncbi.nlm.nih.gov

Simulators for assessing driving skills in demented patients. [2019]