UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057321 |
|---|---|
| Receipt number | R000064374 |
| Scientific Title | Kinematic analysis of swallowing physiology and pathophysiology using Upright Swallowing CT |
| Date of disclosure of the study information | 2025/03/18 |
| Last modified on | 2025/03/18 10:05:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Kinematic analysis of swallowing physiology and pathophysiology using Upright Swallowing CT
Acronym
Kinematic analysis of swallowing using Upright CT
Scientific Title
Kinematic analysis of swallowing physiology and pathophysiology using Upright Swallowing CT
Scientific Title:Acronym
Kinematic analysis of swallowing using Upright CT
Region
| Japan |
Condition
Condition
Normal swallowing and dysphagia
Classification by specialty
| Pneumology | Neurology | Surgery in general |
| Vascular surgery | Oto-rhino-laryngology | Oral surgery |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate swallowing function and physiology using Swallowing CT
To investigate pathophysiology of swallowing using Swallowing CT
Basic objectives2
Others
Basic objectives -Others
To investigate the posture on swallowing by using upright CT and reclining CT
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Timing of swallowing events
Key secondary outcomes
hyolaryngeal trajectory, cross-sectional area of UES, volume of pharyngeal cavity, aspiration/penetration, EAT-10
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Upright CT
Interventions/Control_2
Reclining CT
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
1. Age equal to or more than 20 yeas old
2. No history of dysphagia, stroke, neuromuscular disease, organic disease of the larynx or pharynx, respiratory disease, or upper gastrointestinal disease
3. Patients with dysphagia who are in stable medical condition and who are evaluated swallowing by Videifluoroscopy and video endoscopy
4. Subjects who are given informed consent for the current study and understood the purpose of this study
Key exclusion criteria
1. Subjects who do not provide informed consent
2. Healthy subjects with a history of dysphagia, stroke, neuromuscular disease, organic disease of the larynx or pharynx, respiratory disease, or upper gastrointestinal disease
3. Patients with unstable medical condition
4. Patients who are unable to perform voluntary movement
5. patients who are unable to follow the command
6. Patients who are not taking oral intake
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
4791192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL
0562-93-2167
otaka@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Inamoto |
Organization
Fujita Health University
Division name
Faculty of Rehabilitation, School of Health Sciences
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL
0562939064
Homepage URL
inamoto@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine, School of Medicine, Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Department of Rehabilitation Medicine, School of Medicine, 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
Fujita Health University Ethics Committee
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
Tel
0562-93-2641
irb-sys@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
| 2025 | Year | 03 | Month | 18 | 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
| 2023 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 03 | Month | 18 | Day |
Last modified on
| 2025 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064374
