UMIN-ICDS Clinical Trial

Public title

Verification of the effects of cognitive and oral function training using exergaming and dual tasks

Acronym

Verification of the effectiveness of cognitive and oral function training

Scientific Title

Verification of the effects of cognitive and oral function training using exergaming and dual tasks

Scientific Title:Acronym

Verification of the effectiveness of cognitive and oral function training

Region

Japan

Condition

Oral dysfunction/dementia

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effectiveness of a training program that targets both oral function and cognitive function through an intervention experiment targeting healthy adults aged 40 to 80.The primary endpoints were oral function (pronunciation function) and cognitive function (executive function, short-term memory, and working memory).

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Oral function (pronunciation function) and cognitive function (executive function, short-term memory, and working memory)

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Cognitive/oral function training

Interventions/Control_2

Tablet operation only

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

40

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

Those who understand the purpose and content of this study and have obtained the necessary written consent to participate in the study.

Key exclusion criteria

(1) Those who have or are undergoing treatment for a disorder in their stomatognathic function.
(2) Those who were diagnosed as needing dental treatment during the intervention period.
(3) Persons who are judged to have difficulty in training due to ill-fitting dentures.
(4) Denture users with three or more consecutive missing teeth.
(5) Persons with Eichner classification B2-C3.
(6) A person who lacks sufficient judgment ability.
(8) Persons with a history of mental illness, diabetes, cranial nerve disease, or heart disease (heart disease).
(9) Persons taking drugs that affect cognitive function (e.g. benzodiazepines, antidepressants, central nervous system drugs).
(10) Her score on the MMSE-J (Mini Mental State Examination-Japanese), a screening test for dementia, is
Those with 26 points or less.
(11) Those who are currently participating in another study or who have participated in another study within 2 months before the start of the study.
(12) Those who are unable to participate in the pre-test and post-test conducted before and after the intervention period.
(13) Any other person deemed inappropriate.

Target sample size

46

Name of lead principal investigator

1st name	Toru
Middle name
Last name	Ogawa

Organization

Tohoku University

Division name

Advanced Prosthetic Dentistry

Zip code

9808575

Address

4-1, Seiryo-machi, Aoba-ku, Sendai, MIyagi

TEL

0227178369

Email

toru.ogawa.d7@tohoku.ac.jp

Name of contact person

1st name	Nobuhiro
Middle name
Last name	Yoda

Organization

Tohoku University

Division name

Hospital

Zip code

9808575

Address

4-1, Seiryo-machi, Aoba-ku, Sendai, MIyagi

TEL

0227178369

Homepage URL

Email

nobuhiro.yoda.e2@tohoku.ac.jp

Institute

Tohoku University

Institute

Department

Personal name

Organization

Other

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee Tohoku University Graduate School of Dentistry

Address

4-1, Seiryo-machi, Aoba-ku, Sendai

Tel

022-717-8244

Email

den-syom@grp.tohoku.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

11

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

10

Month

06

Day

Date of IRB

Anticipated trial start date

2023

Year

12

Month

01

Day

Last follow-up date

2025

Year

10

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

11

Month

09

Day

Last modified on

2023

Year

11

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060191