UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063613 |
|---|---|
| Receipt number | R000072803 |
| Scientific Title | Effective clinical application of swallowing-related muscle strength measurement using a hand-held dynamometer and longitudinal evaluation of changes during dysphagia rehabilitation |
| Date of disclosure of the study information | 2026/11/12 |
| Last modified on | 2026/11/12 20:07:57 |
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Basic information
Public title
A study of neck muscle strength measurement and changes during rehabilitation in patients with dysphagia
Acronym
Neck Muscle Strength Longitudinal Study
Scientific Title
Effective clinical application of swallowing-related muscle strength measurement using a hand-held dynamometer and longitudinal evaluation of changes during dysphagia rehabilitation
Scientific Title:Acronym
Longitudinal HHD Assessment of Swallowing-Related Muscle Strength
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate longitudinal changes in neck flexor strength measured using a hand-held dynamometer (HHD) in patients undergoing rehabilitation for dysphagia. It also examines the relationships between neck flexor strength and conventional swallowing assessments to determine whether HHD measurements can be used to evaluate changes during dysphagia rehabilitation.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the clinical utility of muscle strength measurement during dysphagia rehabilitation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the longitudinal change in neck flexor strength measured using a hand-held dynamometer (HHD). Neck flexor strength will be assessed using the Mutas F-1 dynamometer (Anima Corporation) with a cervical attachment. Participants will perform two maximal isometric neck flexion contractions for approximately 3 seconds in a seated position, and the maximum value will be used for analysis. Measurements will be conducted at admission to the convalescent rehabilitation ward, approximately every month, and at discharge to evaluate longitudinal changes in neck flexor strength.
Key secondary outcomes
Secondary outcomes include maximum tongue pressure, Repetitive Saliva Swallowing Test (RSST), Modified Water Swallowing Test (MWST), Food Test (FT), Food Intake LEVEL Scale (FILS), and Functional Oral Intake Scale (FOIS). Assessments will be conducted at admission to the convalescent rehabilitation ward, approximately every month, and at discharge. Longitudinal changes in these measures and their associations with HHD-measured neck flexor strength will be analyzed to evaluate the clinical utility of neck flexor strength 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients admitted to the convalescent rehabilitation ward of Fujioka General Hospital.
2. Patients receiving speech-language therapy for dysphagia.
3. Patients who have provided informed consent to participate in the study.
4. No age restrictions are applied.
Key exclusion criteria
1. Patients with cervical disorders, such as cervical disc herniation.
2. Patients with tongue disorders, such as tongue cancer.
3. Patients who do not provide informed consent to participate in the study.
Target sample size
120
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 Sciences
Zip code
3700006
Address
1-7-1 Toriyamachi, Takasaki City, Gunma
TEL
0273653366
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 Sciences
Zip code
3700006
Address
1-7-1 Toriyamachi, Takasaki City, Gunma
TEL
0273653366
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma Paz University
Address
1-7-1 Toriyamachi, Takasaki City, Gunma
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 12 | 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
25
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
Completed
Date of protocol fixation
| 2025 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 12 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter longitudinal observational study involving patients with dysphagia. Patients receiving speech-language therapy for dysphagia in the convalescent rehabilitation ward of Fujioka General Hospital undergo neck flexor strength measurement using a hand-held dynamometer (HHD). Measurements are performed at admission, approximately every month, and at discharge to evaluate longitudinal changes in muscle strength. Associations with tongue pressure, RSST, MWST, FT, FILS, and FOIS are also examined to assess the clinical utility of neck flexor strength measurement. No treatment interventions are assigned as part of this study.
Management information
Registered date
| 2026 | Year | 11 | Month | 12 | Day |
Last modified on
| 2026 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072803
