UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054731 |
|---|---|
| Receipt number | R000062544 |
| Scientific Title | Effect of digital game intervention on cognitive functions in residents in senior housing: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/04/07 18:00:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of digital game intervention on cognitive functions in older people in residents in senior housing: A Randomized Controlled Trial
Acronym
Effect of digital game intervention on cognitive functions in residents in senior housing
Scientific Title
Effect of digital game intervention on cognitive functions in residents in senior housing: A Randomized Controlled Trial
Scientific Title:Acronym
Effect of digital game intervention on cognitive functions in residents in senior housing
Region
| Japan |
Condition
Condition
Older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to verify the effectiveness of implementing digital games to maintain and improve memory, visuospatial cognition, and executive function in residents in senior housing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Memory, visuospatial ability, executive function, global cognitive function.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The intervention group will play the digital game.
Interventions/Control_2
The control group will continue with their normal life.
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) 65 years of age or older (on the basis of previous studies, the older adults in this study were defined as individuals aged 65 years or older), 2) Mini Mental State Examination-Japanese (MMSE-J) score of 24 points or higher (maximum score: 30 points), 3) Ability to perform the test and tasks in the questionnaire. 4) Ability to operate a game controller without hand impairment, and 5) No regular habit of playing games (less than once a month), such as Nintendo Switch and smartphone-based games on a regular basis.
Key exclusion criteria
1) severe behavioral disorders or medical requirements (e.g., a person whose sitting time is limited because of a disease such as heart failure, and who might be negatively impacted by the game intervention), 2) severe visual or hearing impairments, and 3) refusal to participate in the study.
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 of Rehabilitation 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 of Rehabilitation 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
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
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
| 2024 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 11 | 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
| 2024 | Year | 06 | Month | 22 | Day |
Last modified on
| 2025 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062544
