UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054672 |
|---|---|
| Receipt number | R000054356 |
| Scientific Title | Effects of a device to improve oral function in community-dwelling older people |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/06/16 11:39:24 |
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Basic information
Public title
Development of a device to train the oral function of oldere people
Acronym
Train the oral function
Scientific Title
Effects of a device to improve oral function in community-dwelling older people
Scientific Title:Acronym
Oral function training device for older people
Region
| Japan |
Condition
Condition
oral hypofunction
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify whether the daily sucking training of the resin device we have devised can maintain and improve the complex motor function of the lips and tongue, as well as saliva production, in community-dwelling older people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Oral diadochokinesis (Before intervention, 1 and 2 month after intervention)
Key secondary outcomes
Maximum tongue pressure, Lip closure pressure, Saliva volume, Repetitive saliva swallowing test, Chewing function (Before intervention, 1 and 2 month after intervention)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
The intervention method will be an AB design. First, a period of 1 month without using the device. Next, the participants will be trained to suck the plastic apparatus for one month (5 minutes x 3 times per day).
Interventions/Control_2
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study will include both those who are attending a dental clinic or using home visits and whose oral function has not deteriorated, and those whose oral function has deteriorated due to stroke or other disease or aging. Dentures and caries are included regardless of whether or not they are present.
Key exclusion criteria
This study will exclude subjects who have difficulty understanding the purpose of the study due to cognitive decline or aphasia.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Motoyoshi |
| Middle name | |
| Last name | Morishita |
Organization
Kibi International University
Division name
Department of Physical Therapy
Zip code
716-8508
Address
8,Iga-machi, Takahashi-city, Okayama, Japan
TEL
0866-22-9465
m_mori@kiui.ac.jp
Public contact
Name of contact person
| 1st name | Motoyoshi |
| Middle name | |
| Last name | Morishita |
Organization
Kibi International University
Division name
Department of Physical Therapy
Zip code
716-8508
Address
8,Iga-machi, Takahashi-city, Okayama, Japan
TEL
0866-22-9465
Homepage URL
m_mori@kiui.ac.jp
Sponsor or person
Institute
Kibi International University
Institute
Department
Personal name
Funding Source
Organization
Institute for Food and Health Science, Yazuya Co, Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Inohara Dental & Rehabilitation Office
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Kibi International University
Address
8,Iga-machi, Takahashi-city, Okayama, Japan
Tel
0866-22-9454
t-kuroda@office.jei.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
猪原歯科・リハビリテーション科(広島県)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | 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
22
Results
Voluntary maximal tongue pressure showed a significant increase at 2 months compared to pre-baseline (p<0.01).
Oral diadochokinesis showed a significant increase at 2 months compared to 1 month in /ta/ (p<0.01).
Masticatory ability did not change significantly during either period.
There was a significant increase in lip closure at 2 months compared to pre-baseline and 1 month (p<0.01, p<0.01), respectively.
Results date posted
| 2024 | Year | 06 | Month | 16 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Because the instrument used for the intervention is patent pending
Date of the first journal publication of results
Baseline Characteristics
Twenty-two subjects were included in the study, but two dropped out during the intervention, so 20 subjects (mean age 72.8 +- 8.6 years, age range 60-87 years, 9 males and 11 females) could be measured up to 2 months later. The average number of remaining teeth was 22.5 +- 6.7, and 6 of the subjects were using partial dentures. As for history of central nervous system disease, one subject had a history of cerebral infarction. In terms of motor function, all subjects were at the level of walking independence.
Participant flow
No adverse events. 2 dropouts.
Adverse events
None.
Outcome measures
Voluntary maximal tongue pressure, oral diadochokinesis, saliva volume at rest, repetitive salivary swallowing test, chewing ability, lip closure strength
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 16 | Day |
Last modified on
| 2024 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054356
