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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045805
Receipt No. R000052294
Scientific Title Development of oral function training program for cognitive function of the elderly
Date of disclosure of the study information 2021/12/01
Last modified on 2021/10/20

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Basic information
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
Condition Oral hypofunction
dementia
Classification by specialty
Geriatrics Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes Changes in cognitive and oral function due to training after 6weeks
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Tohoku University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) NTT docomo

IRB Contact (For public release)
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
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
2021 Year 12 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
2021 Year 11 Month 16 Day
Date of IRB
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
Other related information

Management information
Registered date
2021 Year 10 Month 20 Day
Last modified on
2021 Year 10 Month 20 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052294

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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