UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059299 |
|---|---|
| Receipt number | R000067831 |
| Scientific Title | Relationship Between Visual Reaction Time During Sudden Braking in a Driving Simulator and Visuospatial Cognition Evaluated by a Commercial Driving Simulator |
| Date of disclosure of the study information | 2025/10/06 |
| Last modified on | 2025/10/06 10:58:58 |
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Basic information
Public title
Relationship Between Visual Reaction Time During Sudden Braking in a Driving Simulator and Visuospatial Cognition Evaluated by a Commercial Driving Simulator
Acronym
Relationship Between Visual Reaction Time During Sudden Braking in a Driving Simulator and Visuospatial Cognition Evaluated by a Commercial Driving Simulator
Scientific Title
Relationship Between Visual Reaction Time During Sudden Braking in a Driving Simulator and Visuospatial Cognition Evaluated by a Commercial Driving Simulator
Scientific Title:Acronym
Relationship Between Visual Reaction Time During Sudden Braking in a Driving Simulator and Visuospatial Cognition Evaluated by a Commercial Driving Simulator
Region
| Japan |
Condition
Condition
Individuals aged 18 years or older with brain injury who possess a valid drivers license, are capable of performing a simulated driving test, and are willing to participate in the study
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the relationship between visual response time during a hazard-avoidance course in simulated driving and visuospatial cognitive assessment scores obtained using a commercial driving simulator (Honda Safety Navi).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual response time during sudden braking, visuospatial cognitive assessment scores obtained from a commercial driving simulator (Honda Safety Navi), and the scores of the Japanese version of the Stroke Drivers Screening Assessment (J-SDSA)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Simulated Driving
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals aged 18 years or older with brain injury who are capable of performing a simulated driving test (able to operate the steering wheel, accelerator, and brake) and possess a valid drivers license.
Key exclusion criteria
Individuals who do not wish to resume driving
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Sagari |
Organization
Shinshu University
Division name
Division of Occupational Therapy School of Health Science
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto-shi, Nagano
TEL
0263372404
sagaria@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Sagari |
Organization
Shinshu University
Division name
Division of Occupational Therapy School of Health Science
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263372404
Homepage URL
sagaria@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Akira Sagari
Funding Source
Organization
Grants-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine Ethics Review Board
Address
3-1-1 Asahi, Matsumoto, Nagano 390-8621 JAPAN
Tel
0263-37-3099
mdrinri@shinshu-u.ac.jp
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
| 2025 | Year | 10 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 06 | Day |
Last modified on
| 2025 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067831
