UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060582 |
|---|---|
| Receipt number | R000069285 |
| Scientific Title | A prospective cohort study on return to driving among rehabilitation patients |
| Date of disclosure of the study information | 2026/03/05 |
| Last modified on | 2026/03/04 14:41:13 |
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Basic information
Public title
Survey on the current status of return to driving among rehabilitation patients
Acronym
Survey on the current status of return to driving among rehabilitation patients
Scientific Title
A prospective cohort study on return to driving among rehabilitation patients
Scientific Title:Acronym
A prospective cohort study on return to driving among rehabilitation patients
Region
| Japan |
Condition
Condition
Patients who receives driving rehabilitation
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the reality of driving resumption by investigating the actual driving status and safety of rehabilitation patients who have returned to driving based on driving ability assessments
Basic objectives2
Others
Basic objectives -Others
To examine the relationship between clinical evaluations and real-world driving behavior
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accident incidence after returning to driving
Key secondary outcomes
Purpose of driving, the rate of traffic violations
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants who meet all of the following criteria:
1. Patients who wish to resume driving and have provided informed consent to participate in this study
2. Patients who possess a valid driver's license
Key exclusion criteria
Participants meeting any of the following criteria will be excluded:
1. A history of epileptic seizures within the past two years
2. Individuals who do not provide informed consent to participate in this study
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine, School of Medicine, Fujita Health University
Zip code
514-1295
Address
424-1 Otori-cho, Tsu, Mie, Japan
TEL
059-252-1555
makotow@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Watanabe |
Organization
Fujita Health University Nanakuri Memorial Hospital
Division name
Department of Rehabilitation
Zip code
514-1295
Address
424-1 Otori-cho, Tsu, Mie, Japan
TEL
059-252-1555
Homepage URL
makotow@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University Nanakuri Memorial Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kariya Toyota General Hospital,Toyota Regional Medical Center,Sankuro Hospital
Name of secondary funder(s)
Toyota Motor Corporation
IRB Contact (For public release)
Organization
Ethics Review Committee, Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2026 | Year | 03 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Contract in progress
Management information
Registered date
| 2026 | Year | 02 | Month | 04 | Day |
Last modified on
| 2026 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069285
