UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052381 |
|---|---|
| Receipt number | R000059797 |
| Scientific Title | Establishment of pharyngeal contraction training method using manometry and swallowing CT. |
| Date of disclosure of the study information | 2023/10/03 |
| Last modified on | 2023/10/02 20:20:14 |
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Basic information
Public title
Establishment of pharyngeal contraction training method using manometry and swallowing CT.
Acronym
Establishment of Pharyngeal Contraction Enhancement Training in dysphasia Rehabilitation
Scientific Title
Establishment of pharyngeal contraction training method using manometry and swallowing CT.
Scientific Title:Acronym
Establishment of Pharyngeal Contraction Enhancement Training in dysphasia Rehabilitation
Region
| Japan |
Condition
Condition
cerebral infarction
cerebral hemorrhage
cancer
Classification by specialty
| Medicine in general | Rehabilitation medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will examine whether the manometric pressure display can be used effectively as feedback during the swallowing training method. Furthermore, the effect of pharyngeal contraction by the swallowing training method will be verified by CT swallowing.
Basic objectives2
Others
Basic objectives -Others
Non
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pharyngeal pressure, pharyngeal volume
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
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)
Analysis of the mechanism of pharyngeal contraction reinforcement training and investigation of more effective teaching methods
(Study 2)
Investigation of the effect of pharyngeal contraction strengthening training on patients with dysphagia
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
1. healthy subjects and patients with dysphagia who have been fully informed of the study and who have given written consent of their own free will based on a thorough understanding of the study
2. healthy subjects and patients with dysphagia who are 20 years of age or older at the time of consent
Key exclusion criteria
Normal adults
Patients with complaints of dysphagia, stroke, neuromuscular disease, organic disease of the larynx and pharynx, respiratory disease, or upper gastrointestinal disease
Patients with dysphagia
1. patients who are not medically stable
2. patients who are unable to perform voluntary movements due to impaired consciousness
3. other patients who are deemed inappropriate by the principal investigator and principal study author(s)
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Ootaka |
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
| 2020 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 10 | 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=R000059797
