Driving Ability Evaluation System to Improve the Conditional Driving License System: Safety and Feasibility Study.

Not Applicable

Recruiting

• Conditions: Automobile Driving
• Interventions: Device: VR Driving Simulator; Other: Computerized Neurocognitive Function Test; Other: Driver Test Station; Other: On-road field driving Test

• Registration Number: NCT06279520
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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 and cognitive function of healthy drivers. to identify the correlation between their outcomes and the VR driving simulator's result

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 Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-14
• Study Start: 2024-02-19
• Study First Submitted QC: 2024-02-25
• Last Update Submitted: 2024-02-25
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Individuals over the age of 19 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adult drivers	VR Driving Simulator	Individuals over the age of 19 who are currently driving
Adult drivers	Computerized Neurocognitive Function Test	Individuals over the age of 19 who are currently driving
Adult drivers	Driver Test Station	Individuals over the age of 19 who are currently driving
Adult drivers	On-road field driving Test	Individuals over the age of 19 who are currently driving

Primary Outcome Measures

Name	Time	Method
Driving performance in simulator, measured by driving errors	15 minutes	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.
Feasibility of VR driving simulator	2 hours	A questionnaire evaluating symptoms of simulator sickness such as dizziness or nausea and comprehension of contents

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of