UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055179 |
|---|---|
| Receipt number | R000063048 |
| Scientific Title | A Study on Sensory Measurement of Feeding and Swallowing Function Using IFC-TESS and Its Clinical Application |
| Date of disclosure of the study information | 2024/08/06 |
| Last modified on | 2024/08/06 20:13:42 |
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Basic information
Public title
A Study on Sensory Measurement of Feeding and Swallowing Function Using IFC-TESS and Its Clinical Application
Acronym
Study on Sensory Measurement of Feeding and Swallowing Function Using IFC-TESS
Scientific Title
A Study on Sensory Measurement of Feeding and Swallowing Function Using IFC-TESS and Its Clinical Application
Scientific Title:Acronym
Study on Sensory Measurement of Feeding and Swallowing Function Using IFC-TESS
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Medicine in general | Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determine whether the current perception threshold of IFC-TESS can be used for sensory evaluation of feeding and swallowing function, and identify the threshold values that indicate abnormalities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Threshold Measurement Using IFC-TESS Equipment
Key secondary outcomes
EAT-10 and Tongue Pressure Measurement
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Residents who can provide consent at the following special nursing homes for the elderly:
Shinmitsu Special Nursing Home
Sazanka no Sato Special Nursing Home
Towa no Sato Special Nursing Home
Key exclusion criteria
Individuals using implanted electronic medical devices such as pacemakers or implantable cardioverter defibrillators (ICDs).
Target sample size
39
Research contact person
Name of lead principal investigator
| 1st name | TETSURO |
| Middle name | |
| Last name | SAKAI |
Organization
Gunma Paz University
Division name
Faculty of Rehabilitation,Department of Speech-Language-Hearing Therapy
Zip code
370-0006
Address
1-7-1 Tonyamachi, Takasaki City, Gunma Prefecture, Japan
TEL
02733653366
t-sakai@paz.ac.jp
Public contact
Name of contact person
| 1st name | TETSURO |
| Middle name | |
| Last name | SAKAI |
Organization
Gunma Paz University
Division name
Faculty of Rehabilitation,Department of Speech-Language-Hearing Therapy
Zip code
370-0006
Address
1-7-1 Tonyamachi, Takasaki City, Gunma Prefecture, Japan
TEL
02733653366
Homepage URL
t-sakai@paz.ac.jp
Sponsor or person
Institute
Gunma Paz University
Institute
Department
Personal name
Funding Source
Organization
Gunma Paz University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shinmitsu Special Nursing Home
Sazanka no Sato Special Nursing Home
Towa no Sato Special Nursing Home
Name of secondary funder(s)
Food Care Co., Ltd.
IRB Contact (For public release)
Organization
Gunma Paz University
Address
1-7-1 Tonyamachi, Takasaki City, Gunma Prefecture, Japan
Tel
02733653366
t-sakai@paz.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
特別養護老人ホーム 親光（埼玉），特別養護老人ホーム さざんかの郷（埼玉），特別養護老人ホーム とわの郷（埼玉）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cross sectional study
Management information
Registered date
| 2024 | Year | 08 | Month | 06 | Day |
Last modified on
| 2024 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063048
