UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057152 |
|---|---|
| Receipt number | R000065336 |
| Scientific Title | Association of neuropsychological testing, driving simulator assessment, and on-road driving test with the feasibility of driving resumption in people with brain injury |
| Date of disclosure of the study information | 2025/02/27 |
| Last modified on | 2025/08/29 13:39:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Association of driving resumption with cognitive function and driving evaluations after brain injury
Acronym
Association of driving resumption with cognitive function and driving evaluations after brain injury
Scientific Title
Association of neuropsychological testing, driving simulator assessment, and on-road driving test with the feasibility of driving resumption in people with brain injury
Scientific Title:Acronym
Association of neuropsychological testing, driving simulator assessment, and on-road driving test with the feasibility of driving resumption in people with brain injury
Region
| Japan |
Condition
Condition
brain injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the association between participant characteristics, neuropsychological testing, driving simulator assessment, on-road driving test, and the feasibility of driving resumption.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Driving resumption success
Key secondary outcomes
Age, Sex, Side of hemisphere damage, Location of injury. Degree of motor paralysis, Functional Independence Measure, Mini-Mental State Examination, Trail Making Test-A, Trail Making Test-B (TMT-B), Frontal Assessment Battery, Rey Complex Figure Test, Kohs Block Design Test, Stroke Drivers' Screening Assessment Japanese Version
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals with brain injury who were hospitalized or received outpatient treatment at a general hospital.
Those who drove before the injury and wished to resume driving.
Those who were referred for driving evaluation by a physician.
Those whose driving resumption status (resumption or non-resumption) was determined during the follow-up period.
Key exclusion criteria
Those with certain medical conditions (such as dementia, epilepsy, visual field defects, etc.) that would result in suspension or denial of driving license, and who have already been deemed unfit to drive by a physician.
Those whose follow-up regarding the feasibility of driving resumption became difficult during the follow-up period due to recurrence of their condition or self-discontinuation of driving support outpatient services.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Mutai |
Organization
Shinshu University
Division name
Division of occupational therapy, School of health sciences, Faculty of Medicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263372405
hitmutai@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Mutai |
Organization
Shinshu University
Division name
Division of occupational therapy, School of health sciences, Faculty of Medicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263372405
Homepage URL
hitmutai@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saku Central Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University Life Science and Medical Sciences Research Ethics Committee
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-2572
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 | 02 | Month | 27 | 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
| 2025 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Association of neuropsychological testing, driving simulator assessment, and on-road driving test with the feasibility of driving resumption in people with brain injury.
Management information
Registered date
| 2025 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065336
