Driving Ability Evaluation System to Improve the Conditional Driving License System: Feasibility Study of High-risk Drivers.

The primary objective of this study is to verify the safety and validity of a VR driving simulator developed for evaluating the driving abilities of elderly drivers.

This study also aims to establish indicators in VR driving simulator to evaluate high-risk group for driving, such as cognitive and physical abilities. Therefore, this study aims to measure the physical driving function, general physical function and cognitive function of elderly drivers. to identify the correlation between their outcomes and the VR driving simulator's result

Study Overview

• Status: Recruiting
• Conditions: Automobile Driving
• Intervention / Treatment: Device: VR Driving Simulator; Other: Computerized Neurocognitive Function Test; Other: Driver Test Station; Other: On-road field driving Test; Other: Short Physical Performance Battery

Detailed Description

VR driving simulator is to evaluate the driving abilities of high-risk drivers, including the elderly and those with medical conditions, potentially prone to incapacitate driving.

It aims to evaluate whether drivers who were anticipated to have impaired driving ability can handle highly risky situations for traffic accidents. The results of this study can be used to make the drivers know their status and encourage them to take safety training. Until now, the evaluation of driving abilities could only be conducted at licensing centers. However, the use of VR technology can eliminate spatial limitations, offering a promising tool for the objective assessment of driving skills.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ja-Ho Leigh; Phone Number: +82-31-580-5650; Email: magican1@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Ja-Ho Leigh, M.D. Msc.; Email: mazican@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Individuals over the age of 65 who are currently driving.
• Individuals capable of understanding and following the researcher's instructions.
• Individuals who can understand the purpose of the research and have consented to participate

Exclusion Criteria:

• Those who have not signed the consent form.
• Individuals with a history of severe dizziness or epilepsy.
• Patients with restrictions on sitting in a wheelchair or chair for more than 30 minutes.
• Patients with severe shoulder pain.
• Patients whose range of motion in major joints is restricted by more than 50%.
• Pregnant women.
• Patients with pressure sores.
• Patients with limitations on simulator use due to heterotopic ossification.
• Patients with acute fractures.
• Other patients for whom participation in the study is expected difficult.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Elderly drivers; Individuals over the age of 65 who are currently driving

Device: VR Driving Simulator; Evaluation of usual road driving abilities and assessment of response capabilities in accident-prone situations through a VR driving simulator; Other: Computerized Neurocognitive Function Test; Evaluation of cognitive levels including attention and memory (the Trail Making Test, Digit Span Test, Auditory (or Visual) Continuous Performance Test , and Card Sorting); Other: Driver Test Station; Conducting qualified tests of a person's basic physical driving ability including steering, acceleration and braking, using Driver Test Station(Autoadapt AB, Stenkullen, Sweden); Other: On-road field driving Test; Researchers and driver's license supervisors ride in the driver's license test vehicle to evaluate the subject's actual driving ability. the validity of the VR simulator by comparing the results of the VR simulator with the actual vehicle driving ability.; Other: Short Physical Performance Battery; Evaluation of functional capability and provide a measure of the biological age of an older individual by measuring lower extremity physical performance status(standing balance, walking speed, and chair stand tests).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of VR driving simulator	A questionnaire evaluating symptoms of simulator sickness such as dizziness or nausea and comprehension of contents	2 hours
Driving performance in simulator, measured by driving errors	Driving performance in simulator will be measured by driving errors during VR simluation of driving. These errors will be evaluated based on the criteria used for driving license tests, including violations of traffic laws.	15 minutes

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: February 25, 2024
• First Posted (Estimated): March 4, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024-01-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No