UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050292 |
|---|---|
| Receipt number | R000057268 |
| Scientific Title | Effects of self-training using IoT on oral function |
| Date of disclosure of the study information | 2023/02/10 |
| Last modified on | 2023/03/16 21:03:15 |
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Basic information
Public title
Effects of self-training using IoT on oral function
Acronym
Effects of self-training using IoT on oral function
Scientific Title
Effects of self-training using IoT on oral function
Scientific Title:Acronym
Effects of self-training using IoT on oral function
Region
| Japan |
Condition
Condition
low tongue strength
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the effects of oral functional training between IoT-based and paper-based groups.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
maximum tongue pressure
Key secondary outcomes
oral diadochokinesis
occlusal pressure
masticatory performance
etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Program for oral function improvement using IoT, containing six exercises to improve masticatory muscle and performance, tongue, and swallowing muscles for 4 weeks.
Interventions/Control_2
Program for paper-based oral function improvement, containing six exercises to improve masticatory muscle and performance, tongue, and swallowing muscles for 4 weeks.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Community-dwelling older people whose tongue pressure was <30 kPa based on the result of oral function tests, obtained from the Itoshima Frail Study conducted in 2020.
Key exclusion criteria
1)individuals who had nursing care certification
2)individuals who disagree with study
3)receiving prosthetic treatment in the dental clinic
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Hiro |
| Middle name | |
| Last name | Kishimoo |
Organization
Kyushu University
Division name
Department of Behavior and Health Sciences, Graduate School of Human-Environment Studies
Zip code
819-0395
Address
744 Motooka, Nishi-ku, Fukuoka
TEL
092-802-6071
kishimoto@artsci.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiro |
| Middle name | |
| Last name | Kishimoto |
Organization
Kyushu University
Division name
Department of Behavior and Health Sciences, Graduate School of Human-Environment Studies
Zip code
819-0395
Address
744 Motooka, Nishi-ku, Fukuoka
TEL
092-802-6071
Homepage URL
kishimoto@artsci.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Kyushu University
Address
744 Motooka, Nishi-ku, Fukuoka
Tel
092-802-6071
kishimoto@artsci.kyushu-u.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 | 02 | Month | 10 | Day |
Related information
URL releasing protocol
https://ocmcp.dent.kyushu-u.ac.jp/
Publication of results
Unpublished
Result
URL related to results and publications
https://ocmcp.dent.kyushu-u.ac.jp/
Number of participants that the trial has enrolled
26
Results
Two-way analysis of variance revealed that body mass index (p = 0.004) increased, and maximum masticatory performance (p = 0.010), maximum tongue pressure (p = 0.035), and oral diadochokinesis /pa/ and /ka/ (p = 0.009 and 0.017, respectively) improved in a month. Participants with higher tongue pressure improvement have increased intake of animal proteins at baseline: fish (p = 0.022), meat (p = 0.029), and egg (p = 0.009).
Results date posted
| 2023 | Year | 02 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
76 community-dwelling older people whose tongue pressure was <30 kPa based on the result of oral function tests, obtained from the Itoshima Frail Study conducted in 2020.
Participant flow
76 community-dwelling older people whose tongue pressure was <30 kPa based on the result of oral function tests, obtained from the Itoshima Frail Study conducted in 2020. 28 individuals were enrolled, and they consented to participate in the study.
Adverse events
none
Outcome measures
The two-way analysis of variance comparing the tablet- and paper-based groups at baseline and after intervention. The items showing interaction (intervention multiples between groups) included muscle mass (p = 0.024), skeletal muscle mass, p = 0.029, and SMI, p = 0.032. No difference was detected in the pattern of change of interaction for any other item, which indicated that the trend of change was similar between the groups.
No significant difference was observed between the two groups, that is, the tablet group and the paper-based group, both at the baseline and then at follow-up. The items in which the main effects of the intervention were observed included weight (p = 0.003), BMI (p = 0.004), maximum masticatory performance,p = 0.010, maximum tongue pressure (p = 0.035), and ODK /pa/ and /ka/ (p = 0.009 and 0.017, respectively).
The adjusted geometric means of the daily nutrient intake by the increase in tongue pressure at baseline. The participants were classified into the LI and HI groups by a median of 1.3 kPa of the increase in tongue pressure. The intake of animal protein, namely, fish (p = 0.022), meat (p = 0.029), and egg (p = 0.009), was significantly higher in the HI group than in the LI group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 10 | Day |
Last modified on
| 2023 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057268
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