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

NCT ID: NCT06290037

Last Updated: 2024-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2024-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Automobile Driving

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Elderly drivers

Individuals over the age of 65 who are currently driving

Group Type OTHER

VR Driving Simulator

Intervention Type DEVICE

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

Computerized Neurocognitive Function Test

Intervention Type 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)

Driver Test Station

Intervention Type 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)

Short Physical Performance Battery

Intervention Type OTHER

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).

On-road field driving Test

Intervention Type 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.

Interventions

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VR Driving Simulator

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

Intervention Type DEVICE

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)

Intervention Type 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)

Intervention Type 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).

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ja-Ho Leigh

Associate clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Ja-Ho Leigh

Role: CONTACT

+82-31-580-5650

Facility Contacts

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Ja-Ho Leigh, M.D. Msc.

Role: primary

Other Identifiers

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2024-01-003

Identifier Type: -

Identifier Source: org_study_id

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