UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045945 |
|---|---|
| Receipt number | R000052420 |
| Scientific Title | Criteria-related validity of cognitive tasks and cognitive function tests applying Mixed Reality technology |
| Date of disclosure of the study information | 2021/11/05 |
| Last modified on | 2024/05/06 23:37:27 |
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Basic information
Public title
Criteria-related validity of cognitive tasks and cognitive function tests applying Mixed Reality technology
Acronym
Relationship between Mixed Reality tasks and cognitive function tests
Scientific Title
Criteria-related validity of cognitive tasks and cognitive function tests applying Mixed Reality technology
Scientific Title:Acronym
Relationship between Mixed Reality tasks and cognitive function tests
Region
| Japan |
Condition
Condition
Dementia, Mild Cognitive Impairment
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to first verify whether cognitive tasks using mixed reality (MR) correlate with conventional neuropsychological tests. Secondly, the purpose of this study is to confirm whether the MR tasks have a cut-off as a screening for cognitive function tests.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
MR tasks: number cancellation task, selective cancellation task, and flower road task
Key secondary outcomes
Mini-Mental State Examination Japanese version
The Montreal Cognitive Assessment Japanese version
Trail Making Test Japanese version
Tapping Span
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons who can walk with or without walking aids.
Persons who have received sufficient explanation before participating in this study, and who have obtained the consent of the document by their own free will after sufficient understanding.
Key exclusion criteria
Persons who have difficulty understanding tasks due to cognitive or speech disorders.
Persons with markedly impaired visual function.
Persons with vestibular dysfunction.
Persons who are judged by the principal investigator to be inappropriate as research subjects.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Hashimoto |
Organization
Kansai Medical University
Division name
Faculty of Rehabilitation
Zip code
573-1136
Address
Uyamahigashicho 18-89, HIrakata, Osaka
TEL
072-804-0101
hashimsh@makino.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Hashimoto |
Organization
Kansai Medical University
Division name
Faculty of Rehabilitation
Zip code
573-1136
Address
Uyamahigashicho 18-89, HIrakata, Osaka
TEL
072-804-0101
Homepage URL
hashimsh@makino.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Center for Ethical Review
Address
Shinmachi 2-5-1, Hirakata, Osaka
Tel
072-804-2440
rinriirb@hirakata.kmu.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
| 2021 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
https://site.convention.co.jp/jarma06/wp/wp-content/uploads/2022/10/14_shouroku.pdf
Publication of results
Partially published
Result
URL related to results and publications
https://site.convention.co.jp/jarma06/wp/wp-content/uploads/2022/10/14_shouroku.pdf
Number of participants that the trial has enrolled
109
Results
No significant correlation was found between the two mixed reality tasks (number cancellation task and flower road task) and neuropsychological tests.
ROC curve analysis showed that the time required for the mixed reality number cancellation task performed with a visual angle of 180 degrees could be set as a cutoff value for mild cognitive impairment.
Results date posted
| 2024 | Year | 05 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study involved 109 local elderly people who voluntarily participated in response to a call from the local government.
All subjects were independent in their activities of daily living, did not suffer from dementia, and were able to communicate.
Participant flow
After listening to an explanation of the study, subjects who expressed a willingness to participate were asked to fill out a consent form.
The subjects performed the two mixed reality tasks on the same day that they underwent neuropsychological testing. They were allowed to take appropriate breaks if they felt fatigued.
Adverse events
No adverse events were observed.
Outcome measures
Japanese version of Mini Mental State Examination
Japanese version of Trail Making Test
Tapping Span
Timed Up & Go Test
Upper limb reach speed
Mixed reality number cancellation task
Mixed reality Flower Road task
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The subjects of this study are 100 participants attending the daycare center attached to the Kansai Medical University from November 2021 to March 2023 and met the selection criteria. It also targets 100 local volunteers recruited through local governments with which they have cooperated. Volunteers will be recruited from November 2021 to December 2022 through the websites and information magazines published by the local government.
Management information
Registered date
| 2021 | Year | 11 | Month | 01 | Day |
Last modified on
| 2024 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052420
