UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040705 |
|---|---|
| Receipt number | R000046466 |
| Scientific Title | Development of a Convenient Driving Capacity Evaluation Method for Elderly Drivers Using an Eye Scanner |
| Date of disclosure of the study information | 2020/06/10 |
| Last modified on | 2021/10/22 18:19:12 |
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Basic information
Public title
Development of a Convenient Driving Capacity Evaluation Method for Elderly Drivers Using an Eye Scanner
Acronym
Development of a Convenient Driving Capacity Evaluation Method for Elderly Drivers Using an Eye Scanner
Scientific Title
Development of a Convenient Driving Capacity Evaluation Method for Elderly Drivers Using an Eye Scanner
Scientific Title:Acronym
Development of a Convenient Driving Capacity Evaluation Method for Elderly Drivers Using an Eye Scanner
Region
| Japan |
Condition
Condition
old people
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop an evaluation method that can easily evaluate the driving ability of elderly drivers using eye movement measurement, and to develop an index that can be used to judge whether or not to drive a car by comparing the characteristics of healthy elderly people and elderly people with cognitive decline.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gazing point record of driving video observation
Mini-Mental State Examination
Trail Making Test Part-A
Stroke Driver`s Screening Assessment Japanese Version
Revermead Mobility Index Japanese version
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients attending the hospital, walk-in and outpatient rehabilitation patients, and those with a general solicited driver's license. 60-80 people over the age of 75.
Key exclusion criteria
If there was a potential for mood swings (e.g., first-person voyeurism) or fatigue from observing the images or performing the examination.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kawamura |
| Middle name | |
| Last name | Hirokazu |
Organization
Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Korizono-cho, Hirakata City, Osaka
TEL
0728351010
kawaguchi.ns.reha@gmail.com
Public contact
Name of contact person
| 1st name | Iki |
| Middle name | |
| Last name | Shinya |
Organization
Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Korizono-cho, Hirakata City, Osaka
TEL
0728351010
Homepage URL
https://kawaguchi-ns.com/
kawaguchi.ns.reha@gmail.com
Sponsor or person
Institute
Kawaguchi Neurosurgery Rehabilitation Clinic
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Geriatric and Gerontological Behavioral Sciences
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawaguchi Neurosurgery Rehabilitation Clinic
Address
Department of Rehabilitation
Tel
0728351010
kawaguchi.ns.reha@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 10 | Day |
Related information
URL releasing protocol
https://drive.google.com/file/d/1S7na_Ymt-2fV82vNltiFbNy4sfp19FUM/view
Publication of results
Published
Result
URL related to results and publications
https://drive.google.com/file/d/1S7na_Ymt-2fV82vNltiFbNy4sfp19FUM/view
Number of participants that the trial has enrolled
23
Results
The no-problem group showed significantly higher gaze evaluation scores, predicted pass values, and predicted fail values than the discontinuation/problem group.
Results date posted
| 2021 | Year | 10 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In recent years, there has been a rash of accidents involving elderly drivers, and the revised Road Traffic Law, which came into effect in March 2017, requires drivers over the age of 75 to undergo a cognitive function test when renewing their licenses. If the test determines that the driver's cognitive function has declined or is at risk of declining, the driver is required to submit a medical certificate. However, no evaluation method has been developed that can reflect the actual driving ability of the patient and can be conducted efficiently within the normal medical system. For a long time, we have been using a gaze measurement device as an aid to evaluation in our clinic. The device is easy to install, and we have confirmed its usefulness in assessing visuospatial attention in a setting close to that of actual driving situations. Therefore, the purpose of this study was to develop an evaluation method using a gaze-measuring device (hereinafter referred to as "gaze evaluation") that can easily evaluate the driving ability of elderly drivers.
Participant flow
Outpatients, outpatients and outpatient rehabilitation patients, and subjects over 75 years old with a driver's license recruited from the general public will be asked to observe the same driving video with the intention of driving themselves. In addition, Mini-Mental State Examination, Trail Making Test Part-A, screening evaluation for stroke drivers, and Japanese version of Rivermead Mobility Index will be evaluated.
Adverse events
None
Outcome measures
Driving Image Observation Evaluation
Basic Information
Mini-Mental State Examination, Trail Making Test Part-A
Screening Evaluation for Stroke Drivers
Rivermead Mobility Index Japanese version
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-Sectional Research
Management information
Registered date
| 2020 | Year | 06 | Month | 09 | Day |
Last modified on
| 2021 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046466
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