UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000059082
Receipt number R000067583
Scientific Title Effect of 3D digital games on everyday cognitive failures in community-dwelling older adults: A pilot study
Date of disclosure of the study information 2025/10/01
Last modified on 2025/09/13 14:27:42

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Basic information

Public title

Effect of 3D digital games on everyday cognitive failures in community-dwelling older adults

Acronym

Effect of 3D digital games on everyday cognitive failures in community-dwelling older adults

Scientific Title

Effect of 3D digital games on everyday cognitive failures in community-dwelling older adults: A pilot study

Scientific Title:Acronym

Effect of 3D digital games on everyday cognitive failures in community-dwelling older adults: A pilot study

Region

Japan


Condition

Condition

Healthy older adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We will verify whether the implementation of 3D digital games has the effect of maintaining and improving the everyday cognitive failures of community-dwelling older adults.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cognitive failures questionnaire

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

Treatment

Type of intervention

Other

Interventions/Control_1

The participants will play Mario Kart, a 3D digital game, as a group.

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Those who do not regularly play games. Those who have not been diagnosed with dementia. Community-dwelling older adults aged 65 or over.

Key exclusion criteria

Those who have difficulty operating game controllers, those who refuse to participate in the study, and those with severe visual impairments.

Target sample size

20


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

Email

yorozuya.kyosuke@gmail.com


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


Email

yorozuya.kyosuke@gmail.com


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

Email

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

2025 Year 10 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 09 Month 02 Day

Date of IRB

2025 Year 09 Month 02 Day

Anticipated trial start date

2025 Year 10 Month 01 Day

Last follow-up date

2025 Year 10 Month 22 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 09 Month 13 Day

Last modified on

2025 Year 09 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067583