UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052379 |
|---|---|
| Receipt number | R000030588 |
| Scientific Title | Effect of training method and compensation method on swallowing dynamics Analysis using 3D dynamic computed tomography. |
| Date of disclosure of the study information | 2023/10/03 |
| Last modified on | 2023/10/02 19:50:14 |
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Basic information
Public title
Effect of training method and compensation method on swallowing dynamics
Analysis using 3D dynamic computed tomography.
Acronym
Effect of training method and compensation method on swallowing dynamics
Analysis using 3D dynamic computed tomography.
Scientific Title
Effect of training method and compensation method on swallowing dynamics
Analysis using 3D dynamic computed tomography.
Scientific Title:Acronym
Effect of training method and compensation method on swallowing dynamics
Analysis using 3D dynamic computed tomography.
Region
| Japan |
Condition
Condition
Non
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the kinematic effects of techniques used in dysphasia rehabilitation using 320-row area-detector computed tomography (320-ADCT), and to discuss the indications for these techniques.
Basic objectives2
Others
Basic objectives -Others
Non
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharyngeal volume
Key secondary outcomes
Timing of swallowing structure, trajectory of hyolaryngeal, Area of upper esophagus sphincter
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
(Study 1)
Investigation of the mechanism and kinematic effects of pharyngeal contraction strengthening training
(Study 2)
Examination of kinematic effects of swallowing techniques on swallowing dynamics
(Study 3)
Examination of kinematic effects of posture on swallowing dynamics
(Study 4)
Examination of kinematic effects of food morphology on swallowing dynamics
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Volunteers who have no complaints of dysphagia, stroke, neuromuscular disease, organic disease of the larynx or pharynx, respiratory disease, or upper gastrointestinal disease and who can give informed consent for this study will be recruited by posting the study details at the medical institution where the study will be conducted. Volunteers will be informed in writing and orally that their participation or non-participation in the study is voluntary, that they will not be disadvantaged in any way if they do not participate in the study or if the study is terminated, and that if they are employees of medical institutions, their participation in the study will have no relation to their work evaluation. Students of the School of Medicine, School of Health Sciences, or School of Medical Sciences to which the principal investigator and co-investigators belong are not eligible.
Key exclusion criteria
Those with stroke, neuromuscular diseases, organic diseases of the larynx and pharynx, respiratory diseases, a history of upper gastrointestinal diseases or the possibility of pregnancy, and those with diseases for which radiation should not be used (e.g. familial tumors).
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
School of Medicine, Department of Rehabilitation medicine 1
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi 470-1192, JAPAN
TEL
0562-93-2167
yootaka@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Inamoto |
Organization
Fujita Health University
Division name
School of Health Sciences, Faculty of Rehabilitation
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi 470-1192, JAPAN
TEL
0562-93-9000
Homepage URL
inamoto@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health 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
Ethics Review Board of Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi 470-1192, JAPAN
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2023 | Year | 10 | Month | 03 | 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
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 08 | 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
| 2023 | Year | 10 | Month | 02 | Day |
Last modified on
| 2023 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030588
