Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419257
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2023-08-01
Brief Title:
Investigating the Efficacy of an Augmented Virtual Reality Driving Simulator on Institutionalized Dementia Patients
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Investigating the Efficacy of an Augmented Virtual Reality Driving Simulator VRDS on Institutionalized Dementia Patients
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Alzheimers 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 andor 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 Alzheimersdementia 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 games 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
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 Alzheimersdementia 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 games 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
Detailed Description:
The only research instrument is the designed VRDS Virtual Reality Driving Simulator VRDS Experiment The VRDS is a serious game that features three levels of difficulty and routes through a naturalistic country road As the game progresses in each level the route will contain various intersections One intersection is located on the first level while two and three intersections are located on the second and third levels A number of traffic elements are placed along the road Every intersection has a traffic light There are stop signs at a few points throughout each level one stop sign for each of the first two levels and two stop signs for the final level In addition an upcoming vehicle is occasionally placed in the opposite lane and during the initial stages of each level the sudden appearance of a rural animal is simulated
In this study our target users are advanced stage 3 and 4 dementia in particular Alzheimers disease patients who are institutionalized Therefore the VRDS has been designed in a way that when a participant starts using it the game will begin from level 1 In case they successfully complete the level then they will automatically proceed to level 2 If the game remains idle then it will be reset to level 1 There will be no written instructions but an audio messages is played as the warning eg passing a red light without stopping and encouraging messages when they reach a target on the road
User-specific log files are created for each training trial the user plays they are created using an interactive input field before the training begins Our analysis of the logged file lets us know for example whether the users have stopped at traffic signals and stop signs in a timely manner or they have crashed to the curb or havent stopped when an animal jumps to the road etc
The VRDS will be installed in the existing car model in A-B dementia units of the RHC The steering wheel and accelerating pedal of the car will be replaced with the steering wheel and pedals that are used as input controllers of the VRDS game The VRDS screen on the laptop will be projected to the actual front window of the car
In our experience patients with advanced-stage dementia do not feel motion sickness however it is still possible for a participant to feel motion sickness in that case the research assistant next to the participant will stop the program and help the participant to get out of the car and back to their room
In this study our target users are advanced stage 3 and 4 dementia in particular Alzheimers disease patients who are institutionalized Therefore the VRDS has been designed in a way that when a participant starts using it the game will begin from level 1 In case they successfully complete the level then they will automatically proceed to level 2 If the game remains idle then it will be reset to level 1 There will be no written instructions but an audio messages is played as the warning eg passing a red light without stopping and encouraging messages when they reach a target on the road
User-specific log files are created for each training trial the user plays they are created using an interactive input field before the training begins Our analysis of the logged file lets us know for example whether the users have stopped at traffic signals and stop signs in a timely manner or they have crashed to the curb or havent stopped when an animal jumps to the road etc
The VRDS will be installed in the existing car model in A-B dementia units of the RHC The steering wheel and accelerating pedal of the car will be replaced with the steering wheel and pedals that are used as input controllers of the VRDS game The VRDS screen on the laptop will be projected to the actual front window of the car
In our experience patients with advanced-stage dementia do not feel motion sickness however it is still possible for a participant to feel motion sickness in that case the research assistant next to the participant will stop the program and help the participant to get out of the car and back to their room
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None