UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048677 |
|---|---|
| Receipt number | R000055466 |
| Scientific Title | Effect of a Digital Game Intervention for Cognitive functions in Older People: A Single-Case Experimental Design Study |
| Date of disclosure of the study information | 2022/08/30 |
| Last modified on | 2023/11/20 09:23:41 |
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Basic information
Public title
Effect of a Digital Game Intervention for Cognitive functions in Older People
Acronym
Effect of a Digital Game Intervention on Older People
Scientific Title
Effect of a Digital Game Intervention for Cognitive functions in Older People: A Single-Case Experimental Design Study
Scientific Title:Acronym
Effect of a Digital Game Intervention on Older People: A Single-Case Experimental Design Study
Region
| Japan |
Condition
Condition
Older People
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of a game-based non-drug intervention on the maintenance and improvement of cognitive function in older people in a single case design.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Global cognitive function, memory, visuospatial cognitive function, and executive function as measured by brain assessment: Conducted every week from the start of the intervention to the end of follow-up for 4 months.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Participants spend the first two months as usual. Participants then receive game interventions three times a week for two months at a frequency of 30 minutes per session.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) The applicant must have a score of 24 or higher on the Mini-mental state Examination Japanese (MMSE-J). (2) Those who are able to conduct the survey using the questionnaire. (3) Those who are able to operate a game controller without hand/finger impairment.
Key exclusion criteria
(1) Those who indicated their refusal to participate in the study when consent was obtained. (2) Those who have severe visual or hearing impairment. (3) Those who usually play video games on Nintendo Switch or smartphones.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kyosuke |
| Middle name | |
| Last name | Yorozuya |
Organization
Seijoh university
Division name
Faculty Rehabilitation of and Care
Zip code
476-8588
Address
2-172 Fukinodai, Tokai, Aichi
TEL
0526016000
yorozuya@seijoh-u.ac.jp
Public contact
Name of contact person
| 1st name | Kyosuke |
| Middle name | |
| Last name | Yorozuya |
Organization
Seijoh University
Division name
Faculty Rehabilitation of and Care
Zip code
476-8588
Address
2-172 Fukinodai, Tokai, Aichi
TEL
0526016000
Homepage URL
yorozuya@seijoh-u.ac.jp
Sponsor or person
Institute
Seijoh University
Institute
Department
Personal name
Funding Source
Organization
Seijoh University
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
The Research Ethics Committee of Seijoh University
Address
2-172 Fukinodai, Tokai, Aichi
Tel
0526016000
tsutsui@seijoh-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
| 2022 | Year | 08 | Month | 30 | 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
5
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
| 2022 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 08 | Month | 16 | Day |
Last modified on
| 2023 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055466
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
