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

NCT06279520 | Recruiting

• 1 other identifier: 2023-08-003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Automobile Driving

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Adult drivers

OTHER

Individuals over the age of 19 who are currently driving

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

Interventions

VR Driving Simulator DEVICE

Evaluation of usual road driving abilities and assessment of response capabilities in accident-prone situations through a VR driving simulator

Adult drivers

Computerized Neurocognitive Function Test OTHER

Evaluation of cognitive levels including attention and memory (the Trail Making Test, Digit Span Test, Auditory (or Visual) Continuous Performance Test , and Card Sorting)

Adult drivers

Driver Test Station OTHER

Conducting qualified tests of a person's basic physical driving ability including steering, acceleration and braking, using Driver Test Station(Autoadapt AB, Stenkullen, Sweden)

Adult drivers

On-road field driving Test OTHER

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.

Adult drivers

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Central Study Contacts

Ja-Ho Leigh

CONTACT

+82-31-580-5650; magican1@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate clinical professor

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 28, 2024
• Study Start: February 19, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)