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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040705
Receipt No. 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 2020/06/09

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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
Email 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/
Email kawaguchi.ns.reha@gmail.com

Sponsor
Institute Kawaguchi Neurosurgery Rehabilitation Clinic
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
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
2020 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046466

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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