UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052840 |
|---|---|
| Receipt number | R000060302 |
| Scientific Title | Effects of postural changes on tongue base movement and pharyngeal contraction in patients with dysphagia |
| Date of disclosure of the study information | 2023/11/19 |
| Last modified on | 2024/05/20 09:15:40 |
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Basic information
Public title
Effects of postural changes on tongue base movement and pharyngeal contraction in patients with dysphagia
Acronym
Effects of postural changes on tongue base movement and pharyngeal contraction in patients with dysphagia
Scientific Title
Effects of postural changes on tongue base movement and pharyngeal contraction in patients with dysphagia
Scientific Title:Acronym
Effects of postural changes on tongue base movement and pharyngeal contraction in patients with dysphagia
Region
| Japan |
Condition
Condition
Patients with dysphagia
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify whether changes in sitting posture immediately affect both tongue base movement during mastication and pharyngeal contraction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In swallowing endoscopy, we evaluate the motility of the tongue base during mastication and compare the pharyngeal residue during swallowing before and after postural changes.
Key secondary outcomes
Compare masticatory efficiency, number of mastications, and tongue pressure before and after posture change.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
During a swallowing endoscopy performed during a single medical treatment, tongue base movement during mastication before and after posture adjustment, as well as pharyngeal retention and whiteout time are measured. Additionally, tongue pressure, masticatory efficiency, and number of mastications are measured as secondary measures.
Changes in posture are measured using the hunchback index.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient underwent swallowing evaluation using a swallowing endoscope (VE) at the medical facility where the research representative works, is able to eat regular meals and drink liquids, and has provided documentation of voluntary consent to participate in the study. Targeted at those who can obtain it.
Key exclusion criteria
Exclude patients whose molar occlusion has collapsed and has not been restored with dentures.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Kurachi |
Organization
International University of Health and Welfare
Division name
Graduate School of Health and Welfare, Department of Health and Medical Sciences, Speech and Hearing Department
Zip code
286-8686
Address
4-3 Kozunomori, Narita City, Chiba Prefecture
TEL
0476-20-7701
mkurachi@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Ishigaki |
Organization
International University of Health and Welfare
Division name
Department of Health and Medical Sciences, Speech and Hearing Field, Master's Program
Zip code
400-0117
Address
3990 Nishiyahata, Kai City, Yamanashi Prefecture
TEL
055-278-2016
Homepage URL
22s1008@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kai Rehabilitation Clinic
Address
3990 Nishiyahata, Kai City, Yamanashi Prefecture
Tel
055-278-2016
22s1008@g.iuhw.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
22-Ig-206
Org. issuing International ID_1
International University of Health and Welfare
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 | 11 | Month | 19 | 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
15
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
| 2023 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 06 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 19 | Day |
Last modified on
| 2024 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060302
