UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052749 |
|---|---|
| Receipt number | R000060191 |
| Scientific Title | Verification of the effects of cognitive and oral function training using exergaming and dual tasks |
| Date of disclosure of the study information | 2023/11/10 |
| Last modified on | 2023/11/10 20:54:59 |
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Basic information
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
Condition
Oral dysfunction/dementia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
Primary outcomes
Oral function (pronunciation function) and cognitive function (executive function, short-term memory, and working memory)
Key secondary outcomes
Base
Study type
Interventional
Study design
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
Intervention
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
Eligibility
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
Research contact person
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
toru.ogawa.d7@tohoku.ac.jp
Public contact
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
nobuhiro.yoda.e2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
| 2023 | Year | 11 | Month | 10 | 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
| 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
Other related information
Management 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/ctr_e/ctr_view.cgi?recptno=R000060191
