UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062298 |
|---|---|
| Receipt number | R000071293 |
| Scientific Title | The effectiveness of a group intervention for those who have stopped driving after brain injury. |
| Date of disclosure of the study information | 2026/07/22 |
| Last modified on | 2026/07/22 10:34:55 |
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Basic information
Public title
The effectiveness of a group intervention for those who have stopped driving after brain injury.
Acronym
The effectiveness of a group intervention for those who have stopped driving after brain injury.
Scientific Title
The effectiveness of a group intervention for those who have stopped driving after brain injury.
Scientific Title:Acronym
The effectiveness of a group intervention for those who have stopped driving after brain injury.
Region
| Japan |
Condition
Condition
Brain injury
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Testing the effectiveness of group intervention for those who have stopped driving after brain injury.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Assessment of Readiness for Mobility Transition
In the intervention group, measurements will be taken at baseline and at the end of Phase 1.
In the control group, measurements will be taken at baseline, at the end of Phase 1, and at the end of Phase 2.
Key secondary outcomes
Client Satisfaction Questionnaire 8
In the intervention group, measurements will be taken at the end of Phase 1.
In the control group, measurements will be taken at the end of Phase 2.
Life Satisfaction
Measurements will be taken at the same time as ARMT-J.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention group will receive the group intervention focusing on driving discontinuation and local transportation in Phase 1. In Phase 2, neither assessments nor interventions will be conducted.
Interventions/Control_2
The contorol group will receive standard information using a guidebook in Phase 1. They will receive the group intervention focusing on driving discontinuation and local transportation in Phase 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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons diagnosed with brain injury
Those who have stopped driving after brain injury
Persons whose consent was obtained after receiving an explanation.
Key exclusion criteria
Persons whose driving with no restrictions
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ayami |
| Middle name | |
| Last name | Yoshihara |
Organization
Nagoya City Rehabilitation Agency
Division name
Division of Support for Persons with Higher Brain Dysfunctions
Zip code
467-8622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
n-koujinou@nagoya-rehab.or.jp
Public contact
Name of contact person
| 1st name | Ayami |
| Middle name | |
| Last name | Yoshihara |
Organization
Nagoya City Rehabilitation Agency
Division name
Division of Support for Persons with Higher Brain Dysfunctions
Zip code
467-8622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
Homepage URL
n-koujinou@nagoya-rehab.or.jp
Sponsor or person
Institute
Nagoya City Rehabilitation Agency
Institute
Department
Personal name
Funding Source
Organization
Nagoya City Rehabilitation Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City Rehabilitation Agency
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
Tel
052-835-3811
soumubu@nagoya-rehab.or.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
名古屋市総合リハビリテーション事業団(愛知県)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 22 | 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 | 07 | Month | 22 | Day |
Last modified on
| 2026 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071293
