UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058088 |
|---|---|
| Receipt number | R000061023 |
| Scientific Title | Effect of eating utensils on eating posture -Eating posture analysis using gyro sensor- |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/05 11:37:40 |
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Basic information
Public title
Effect of eating utensils on eating posture -Eating posture analysis using gyro sensor-
Acronym
Effect of eating utensils on eating posture
Scientific Title
Effect of eating utensils on eating posture -Eating posture analysis using gyro sensor-
Scientific Title:Acronym
Effect of eating utensils on eating posture
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify the influence of eating utensils on eating posture, which is important for eating and swallowing functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum angle change (roll angle, pitch angle, yaw angle) obtained from gyro sensors installed on the head, neck, and chest
Key secondary outcomes
Events observed by video camera photography (presence or absence of choking, failure to swallow, number of swallowing attempts)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Cup with U-shaped notch
Interventions/Control_2
nursing cup
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A healthy person who is able to communicate.
No problems were found in the swallowing function screening evaluation using EAT-10.
Key exclusion criteria
Those who are unable to communicate sufficiently, those who have abnormalities found on EAT-10. Persons who have difficulty wearing the device for some reason.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takatoshi |
| Middle name | |
| Last name | Iida |
Organization
Health Sciences University of Hokkaido
Division name
Division of Dysphagia Rehabilitation
Zip code
061-0293
Address
1757 Kanazawa, Tobetsu-cho, Ishikari-gun, Hokkaido
TEL
0133-23-1211
tiida@hoku-iryo-u.ac.jp
Public contact
Name of contact person
| 1st name | Takatoshi |
| Middle name | |
| Last name | Iida |
Organization
Health Sciences University of Hokkaido
Division name
Division of Dysphagia Rehabilitation
Zip code
061-0293
Address
1757 Kanazawa, Tobetsu-cho, Ishikari-gun, Hokkaid
TEL
0133-23-1211
Homepage URL
tiida@hoku-iryo-u.ac.jp
Sponsor or person
Institute
Health Sciences University of Hokkaido
Institute
Department
Personal name
Funding Source
Organization
Self
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Health Sciences University of Hokkaido
Address
1757 Kanazawa, Tobetsu-cho, Ishikari-gun, Hokkaido
Tel
0133-23-1211
tiida@hoku-iryo-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
北海道医療大学病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | 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
| 2024 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 05 | Day |
Last modified on
| 2025 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061023
