UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045805 |
|---|---|
| Receipt number | 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 | 2022/10/21 09:16:15 |
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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
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
nobuhiro.yoda.e2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
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
Other related information
Management 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
