UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059298 |
|---|---|
| Receipt number | R000059278 |
| Scientific Title | Development of a simulated driving test with eye measurement for stroke and brain injury patients with hemispatial neglect. |
| Date of disclosure of the study information | 2025/10/06 |
| Last modified on | 2025/10/06 11:01:33 |
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Basic information
Public title
Development of a simulated driving test with eye measurement for stroke and brain injury patients with hemispatial neglect.
Acronym
Development of a simulated driving test with eye measurement for stroke and brain injury patients with hemispatial neglect.
Scientific Title
Development of a simulated driving test with eye measurement for stroke and brain injury patients with hemispatial neglect.
Scientific Title:Acronym
Development of a simulated driving test with eye measurement for stroke and brain injury patients with hemispatial neglect.
Region
| Japan |
Condition
Condition
Stroke/brain injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to develop an objective index for determining whether a person can resume driving, using the results of the Stroke Driver's Screening Assessment Japanese Version (J-SDSA) as an external criterion, and using the gaze and measurement data (including neuropsychological tests and motor ability tests) of PSR, SPR, prefrontal cortex oxyHb, etc. in stroke and brain injury victims. The objective of this study is to develop an objective index to judge whether or not a person can resume driving, using the results of the Stroke Driver's Screening Assessment Japanese Version (J-SDSA) as an external criterion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of hazardous object visibility
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Driving simulators are done for all.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Stroke and brain injury victims aged 18 and over undergoing rehabilitation at Shinshu University Hospital.
2 Right hemisphere injury and right-handedness
3 Persons who are capable of performing the simulated driving test
4 Subjects who have given a full explanation of their participation in this study and who have given written consent of their own free will.
5 Persons who have a driving licence.
Key exclusion criteria
Persons with severe visual impairment (reduced visual acuity: corrected vision less than 0.7 in both eyes, visual field constriction, visual blindness, colour weakness, etc.).
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Sagari |
Organization
Shinshu University
Division name
Division of Occupational Therapy School of Health Science
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano 390-8621 JAPAN
TEL
0263372404
sagaria@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Sagari |
Organization
Shinshu University
Division name
Division of Occupational Therapy School of Health Science
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano 390-8621 JAPAN
TEL
0263372404
Homepage URL
sagaria@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu university
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine Ethics Review Board
Address
3-1-1 Asahi, Matsumoto, Nagano 390-8621 JAPAN
Tel
0263-37-3099
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 | 10 | Month | 06 | 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
47
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
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 06 | Day |
Last modified on
| 2025 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059278
