UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055672 |
|---|---|
| Receipt number | R000063619 |
| Scientific Title | Electromyographic study of supraglottic muscle group training for dysphagia |
| Date of disclosure of the study information | 2024/09/30 |
| Last modified on | 2024/09/30 08:14:35 |
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Basic information
Public title
Electromyographic study of swallowing training
Acronym
Electromyography study of swallowing training
Scientific Title
Electromyographic study of supraglottic muscle group training for dysphagia
Scientific Title:Acronym
Electromyography study of swallowing training
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to analyze electromyographically the effect of muscle strengthening on the supraspinatus muscle in various supraspinatus muscle training in order to establish a efficient training method of instruction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle activity in surface electromyography of the supraspinatus muscles
Key secondary outcomes
Age, Gender
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Measuring the electromyogram of swallowing training
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Normal on dysphagia questionnaire, repeated saliva swallow test, and water swallow test
Key exclusion criteria
Has physical and neurological problems
Has functional and organic problems in the oral cavity
Has abnormal feeding and swallowing function
Inability to understand oral instructions
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Ohki |
Organization
Saitama Medical University, Saitama Medical Center
Division name
Department of Otolaryngology
Zip code
350-8550
Address
1981 Kamoda, Kawagoe-shi, Saitama
TEL
049-228-3685
masaohki@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Ohki |
Organization
Saitama Medical University, Saitama Medical Center
Division name
Department of Otolaryngolog
Zip code
350-8550
Address
1981 Kamoda, Kawagoe-shi, Saitama
TEL
049-228-3685
Homepage URL
masaohki@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University, Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University Saitama Medical Center
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
Saitama Medical University Saitama Medical Center
Address
1981 Kamoda, Kawagoe-shi, Saitama
Tel
049-228-3685
masaohki@saitama-med.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
| 2024 | Year | 09 | Month | 30 | 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 | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | 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
| 2024 | Year | 09 | Month | 30 | Day |
Last modified on
| 2024 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063619
