UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045073 |
|---|---|
| Receipt number | R000051493 |
| Scientific Title | Development of a comprehensive evaluation system for resumption of driving for people with brain injury |
| Date of disclosure of the study information | 2021/08/05 |
| Last modified on | 2025/02/28 17:41:04 |
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Basic information
Public title
Development of a comprehensive evaluation system for resumption of driving for people with brain injury
Acronym
Development of a comprehensive evaluation system for resumption of driving for people with brain injury
Scientific Title
Development of a comprehensive evaluation system for resumption of driving for people with brain injury
Scientific Title:Acronym
Development of a comprehensive evaluation system for resumption of driving for people with 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
Validate effectiveness of a comprehensive evaluation system for resumption of driving for people with brain injury
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Whether or not to take the aptitude consultation and aptitude test
Key secondary outcomes
Continued driving or not
Experience of danger while driving
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Drive on the road using a training car and provide guidance
Interventions/Control_2
No intervention
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who have been diagnosed by a physician as having brain injury (cerebrovascular accident, traumatic brain injury, hypoxic encephalopathy, encephalitis, brain tumor) and have been instructed to undergo a driving evaluation.
Those who have given their written consent to participate in this study after receiving sufficient explanation and understanding.
Key exclusion criteria
Person who withdrew consent to provide information.
Target sample size
70
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 Occupational Therapy
Zip code
467-8622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
ot-dep@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 Occupational Therapy
Zip code
467-8622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
Homepage URL
ot-dep@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
| 2021 | Year | 08 | Month | 05 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
170
Results
Regarding "whether or not they had received safe driving counseling and taken the temporary aptitude test," 12 of the 26 drivers who continued driving before the program and 14 of those who had not taken the test, while 38 of the 42 drivers who resumed driving after the program and 4 of those who had not taken the test were in the group before the program. The number of those who had not yet taken the test was 4.
Results date posted
| 2025 | Year | 02 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were 41 in the pre-program operation group (37 males and 4 females, mean age 53.85+-12.14 years) and 56 in the post-program operation group (50 males and 6 females, mean age 53.35+-11.16 years). Of these, 26 in the pre-program group and 42 in the post-program group indicated that they had resumed driving.
Participant flow
In the pre-program group, 2 out of 77 questionnaires were returned to an unknown address, and 34 did not respond, for a response rate of 53.7% (41/77).
In the post-program group, 37 of 93 respondents did not respond, for a response rate of 60.2% (56/93).
The number of valid respondents was 41 in the pre-program operation group and 56 in the post-program operation group.
Adverse events
none
Outcome measures
Regarding "whether or not they had received safe driving counseling and taken the temporary aptitude test," 12 (46.2%) of the 26 drivers who continued driving before the program and 14 (53.8%) of those who had not taken the test, while 38 (90.5%) of the 42 drivers who resumed driving after the program and 4 (9.5%) of those who had not taken the test were in the group before the program. The number of those who had not yet taken the test was 4 (9.5%). The results of the comparison of the rates of safe driving counseling and temporary aptitude tests showed a significant difference between the pre- and post-program groups (p<0.01).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 05 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051493
