UMIN-CTR Clinical Trial

Public title

Development of oral function training program for cognitive function of the elderly

Acronym

Development of oral and cognitive function training programs

Scientific Title

Development of oral function training program for cognitive function of the elderly

Scientific Title:Acronym

Development of oral and cognitive function training programs

Region

Japan

Condition

Oral hypofunction
dementia

Classification by specialty

Geriatrics

Dental medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To develop training methods based on Gamification techniques to improve not only oral function but also cognitive function

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Changes in cognitive and oral function due to training after 6weeks

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Oral and cognitive training using tablet computer

Interventions/Control_2

Oral function training using a tablet computer

Interventions/Control_3

Control training group using tablet computer (no load on cognitive / oral function)

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

60

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Men and women aged 60-80 (at the time of registration).
(2) Right-handed person.
(3) Those who have completed the COVID-19 vaccine twice.
(4) Those who understand the purpose and content of this research and have obtained the consent to participate in the research in writing.

Key exclusion criteria

(1) Those who have a disorder of stomatognathic function or who are undergoing treatment for it.
(2) Those who need to go to the dental clinic for dental treatment during the intervention period.
(3) Those who are judged to interfere with training due to denture incompatibility.
(4) Denture users with 3 or more consecutive defects.
(5) Eihiner classification B2-C3.
(6) Those who play games for one hour or more a week.
(7) Adults who do not have sufficient judgment ability.
(8) Persons with a history of mental illness, diabetes, cranial nerve disease, or heart disease.
(9) Those taking drugs that affect cognitive function (eg, benzodiazepines, antidepressants, central nervous system drugs).
(10) Those who have a score of 26 points or less in her MMSE-J (Mini Mental State Examination-Japanese), which is a screening test for dementia.
(11) Those who are currently participating in other exams, or those who have participated in other exams within 2 months before the start of the exam.
(12) Those who cannot participate in the pre-examination and post-examination conducted before and after the intervention period.
(13) Others who are judged to be inappropriate.

Target sample size

63

Name of lead principal investigator

1st name	Keiichi
Middle name
Last name	Sasaki

Organization

Tohoku University

Division name

Graduate School of Dentistry

Zip code

980-8575

Address

Sendai

TEL

0227178369

Email

keiichi.sasaki.e6@tohoku.ac.jp

Name of contact person

1st name	Nobuhiro
Middle name
Last name	Yoda

Organization

Tohoku University Hospital

Division name

Advanced Prosthetic Dentistry

Zip code

9808575

Address

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

TEL

0227178369

Homepage URL

Email

nobuhiro.yoda.e2@tohoku.ac.jp

Institute

Tohoku University

Institute

Department

Personal name

Organization

Tohoku University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

NTT docomo

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

2021

Year

12

Month

01

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

No longer recruiting

Date of protocol fixation

2021

Year

11

Month

16

Day

Date of IRB

2022

Year

02

Month

08

Day

Anticipated trial start date

2021

Year

12

Month

01

Day

Last follow-up date

2023

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

10

Month

20

Day

Last modified on

2022

Year

10

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052294