UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057667 |
|---|---|
| Receipt number | R000065886 |
| Scientific Title | The effectiveness of virtual reality simulation in improving visual cognitive function |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2025/04/21 14:48:49 |
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Basic information
Public title
Verification of the effectiveness of vision training using virtual reality simulation to improve visual cognitive functions necessary for driving
Acronym
The Effectiveness of Visual Training Using Virtual Reality Simulation
Scientific Title
The effectiveness of virtual reality simulation in improving visual cognitive function
Scientific Title:Acronym
The Effectiveness of Visual Training Using Virtual Reality Simulation
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to enhance the visual cognitive functions of older adults through vision training using virtual reality devices and to verify the effectiveness of this training in improving driving skills while reducing traffic accidents and violations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. on-road driving ability
2. vehicle crash and traffic violation
Key secondary outcomes
1. cognitive function(memory, attention, executive function, processing speed)
2. Adverse events associated with the use of VR devices
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention group: Visual training (once a week, 10 sessions in total)
Interventions/Control_2
Control group: 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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Independent adults aged 60 years who live in the community
2. Those who regularly drive a car
Key exclusion criteria
1. Individuals without a valid driver's license at the beginning of the study
2. Individuals who do not regularly drive a car at the beginning of the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Shimada |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Preventive Gerontology
Zip code
474-8511
Address
7-430 Morioka-cho, Obu, Aichi, Japan
TEL
0562-46-8264
driving_consortium@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Fumio |
| Middle name | |
| Last name | Sakimoto |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Preventive Gerontology
Zip code
474-8511
Address
7-430 Morioka-cho, Obu, Aichi, Japan
TEL
0562-46-8264
Homepage URL
driving_consortium@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology
Address
7-430 Morioka-cho, Obu, Aichi, Japan
Tel
0562-46-2311
driving_consortium@ncgg.go.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 | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 01 | 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
| 2025 | Year | 04 | Month | 21 | Day |
Last modified on
| 2025 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065886
