UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062003 |
|---|---|
| Receipt number | R000062179 |
| Scientific Title | Development of a novel driver rehabilitation system for individuals with higher brain dysfunction |
| Date of disclosure of the study information | 2026/06/22 |
| Last modified on | 2026/06/22 13:19:07 |
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Basic information
Public title
Development of a novel driver rehabilitation system for individuals with higher brain dysfunction
Acronym
Driver Rehabilitation System (Higher Brain Dysfunction)
Scientific Title
Development of a novel driver rehabilitation system for individuals with higher brain dysfunction
Scientific Title:Acronym
Driver Rehabilitation System for Higher Brain Dysfunction
Region
| Japan |
Condition
Condition
higher brain dysfunction
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a novel driver rehabilitation system for individuals with brain injury whose driving is restricted due to higher brain dysfunction, and to evaluate its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
On-road driving errors
Key secondary outcomes
Paper-and-pencil cognitive assessments
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
novel driver rehabilitation system
Interventions/Control_2
conventional rehabilitation
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with higher brain dysfunction who failed the driving skills assessment
Key exclusion criteria
Patients with physical disabilities that impair driving
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasutaka |
| Middle name | |
| Last name | Kobayashi |
Organization
Fukui Health Science University
Division name
Graduate School of Health Science
Zip code
910-3190
Address
55-13-1 Egami-cho, Fukui city, Fukui
TEL
+81-776-59-2200
yasutaka_k@fukui-hsu.ac.jp
Public contact
Name of contact person
| 1st name | Yasutaka |
| Middle name | |
| Last name | Kobayashi |
Organization
Fukui Health Science University
Division name
Graduate School of Health Science
Zip code
910-3190
Address
55-13-1 Egami-cho, Fukui city, Fukui
TEL
+81-776-59-2200
Homepage URL
yasutaka_k@fukui-hsu.ac.jp
Sponsor or person
Institute
Fukui Health Science University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Nittazuka Medical Welfare Center Ethics Committee
Address
58-16-1 Egami-cho, Fukui city, Fukui
Tel
+81-776-59-1300
hisyo-fgh@f-gh.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 | 06 | Month | 22 | 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
| 2024 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 06 | Month | 22 | Day |
Last modified on
| 2026 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062179
