UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055178 |
|---|---|
| Receipt number | R000063047 |
| Scientific Title | A Study on the Clinical Application of Swallowing Muscle Strength Measurement Using a Hand-Held Dynamometer |
| Date of disclosure of the study information | 2024/08/06 |
| Last modified on | 2025/05/12 20:26:32 |
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Basic information
Public title
A Study on the Clinical Application of Swallowing Muscle Strength Measurement Using a Hand-Held Dynamometer
Acronym
Study on the Measurement of Swallowing Muscle Strength Using a Hand-Held Dynamometer (HDD)
Scientific Title
A Study on the Clinical Application of Swallowing Muscle Strength Measurement Using a Hand-Held Dynamometer
Scientific Title:Acronym
Study on the Measurement of Swallowing Muscle Strength Using a Hand-Held Dynamometer (HDD)
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Medicine in general | Pneumology | Geriatrics |
| Oto-rhino-laryngology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to establish the assessment of feeding and swallowing function through muscle strength measurement using a hand-held dynamometer by validating its use in clinical settings.
Basic objectives2
Others
Basic objectives -Others
A secondary objective is to calculate cutoff values to facilitate the screening of feeding and swallowing disorders.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle Strength Measurement of Feeding and Swallowing Function Using a Hand-Held Dynamometer
Key secondary outcomes
Tongue Pressure Measurement, FILS (Food Intake Level Scale), FOIS (Functional Oral Intake Scale)
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
Individuals hospitalized with or suspected of having feeding and swallowing disorders at the following hospitals, who do not meet the exclusion criteria and can provide consent for the study:
Fujioka General Hospital
Kiryu Kosei General Hospital
Numata Neurosurgery and Cardiology Hospital
Key exclusion criteria
Individuals with cervical spine disorders such as cervical hernia.
Target sample size
184
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
3700006
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
TETSURO SAKAI
Funding Source
Organization
Gunma Paz University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Public Fujioka General Hospital
Kiryu Kosei General Hospital
Numata Neurosurgery and Cardiology Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma Paz University
Address
1-7-1 Tonyamachi, Takasaki City, Gunma Prefecture, Japan
Tel
0273653366
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
公立藤岡総合病院（群馬県）
桐生厚生総合病院（群馬県）
沼田脳神経外科循環器科病院（群馬県）
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 | 03 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 31 | 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
| 2025 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063047
