UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049769 |
|---|---|
| Receipt number | R000056678 |
| Scientific Title | Behavioral responses and gaze analysis when viewing driving videos in a virtual reality environment |
| Date of disclosure of the study information | 2022/12/14 |
| Last modified on | 2023/04/10 14:38:09 |
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Basic information
Public title
Behavioral responses and gaze analysis when viewing driving videos in a virtual reality environment
Acronym
Behavioral responses and gaze analysis when viewing driving videos in a virtual reality environment
Scientific Title
Behavioral responses and gaze analysis when viewing driving videos in a virtual reality environment
Scientific Title:Acronym
Behavioral responses and gaze analysis when viewing driving videos in a virtual reality environment
Region
| Japan |
Condition
Condition
Healthy Adults
Older Adults
Stroke Patients
Classification by specialty
| Neurology | Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the characteristics of each driver by viewing driving videos in a virtual reality (VR) environment and analyzing their behavioral responses and gaze during the videos.
Basic objectives2
Others
Basic objectives -Others
Clarify the characteristics of each driver by viewing driving videos in a virtual reality environment.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gaze analysis
Key secondary outcomes
Behavioral responses
Mini Mental State Examination
Trail Making Test
Rey - Osterrieth Complex Figure Test
Frontal Assessment Battery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Healthy adults view driving videos and operate the accelerator and brake in a VR environment.
Interventions/Control_2
Healthy elderly view driving videos and operate the accelerator and brake in a VR environment.
Interventions/Control_3
Stroke patients view driving videos and operate the accelerator and brake in a VR environment.
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
Healthy adults and healthy elderly patients.
Stroke patients attending or hospitalized at Komono Kosei Hospital.
Key exclusion criteria
Those who cannot see images even with vision correction due to visual impairment.
Those with cognitive impairment (MMSE score of 27 or less).
Patients who need medication due to psychological factors.
For patients with cerebrovascular disease, the MMSE score will not be used.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Noguchi |
Organization
Suzuka University of Medical Science
Division name
Department of Rehabilitation, Faculty of Health Science
Zip code
510-0293
Address
Kishioka 1001-1, Suzuka City, Mie
TEL
059-383-8991
reha.noguchi.ot@gmail.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Noguchi |
Organization
Suzuka University of Medical Science
Division name
Department of Rehabilitation, Faculty of Health Science
Zip code
510-0293
Address
Kishioka 1001-1, Suzuka City, Mie
TEL
059-383-8991
Homepage URL
reha.noguchi.ot@gmail.com
Sponsor or person
Institute
Suzuka University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research Japan society of 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
Suzuka University of Medical Science
Address
Minamitamagaki 3500-3, Suzuka City, Mie
Tel
059-340-0550
mayumi@suzuka-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
菰野厚生病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 14 | 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
| 2022 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2022 | Year | 12 | Month | 13 | Day |
Last modified on
| 2023 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056678
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
