UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050695 |
|---|---|
| Receipt number | R000053623 |
| Scientific Title | Studies of the effects of body postural changes on the swallowing function. |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/03/28 12:09:55 |
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Basic information
Public title
Studies of the effects of body postural changes on the swallowing function.
Acronym
Studies of the effects of body postural changes on the swallowing function.
Scientific Title
Studies of the effects of body postural changes on the swallowing function.
Scientific Title:Acronym
Studies of the effects of body postural changes on the swallowing function.
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identify changes in swallowing function due to differences in posture
in healthy adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
tongue pressure
Key secondary outcomes
occlusal force
Muscular activity of the supraohyoid muscle group
sitting pressure
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Measure tongue pressure, occlusal force, muscle activity of the upper and lower hyoid muscle groups, and sitting pressure in each posture.
1.In wheelchair sitting position, knees shoulder-width apart
2.In wheelchair sitting position, knees close together
3.In a sitting position on the bed, knees shoulder-width apart
4.In a sitting position on the bed, knees close togethe
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults with documented consent
Key exclusion criteria
1) Persons with a diagnosis of dysphagia
2) Persons with anatomical (static) disabilities to feeding and swallowing disorders
3) Persons of childbearing potential, or who are pregnant or breastfeeding
4) Those who experience nausea, pain, or other discomfort from tooth or tongue stimulation
5) Those who wear dentures.
6) Patients who have dementia or have communication difficulties and have difficulty communicating.
7) Those who are objectively judged to lack the ability to give informed consent.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | megumi |
| Middle name | |
| Last name | miyamoto |
Organization
Kumamoto Health Science University
Division name
Faculty of Health Science Depertment of Rehabilitation Division of Speech-Language-Hearing Therapy
Zip code
861-5598
Address
325 Izumimachi,Kita-ku,Kumamoto
TEL
096-275-2212
meg-miya@kumamoto-hsu.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Nagano |
Organization
Kumamoto Health Science University
Division name
Planning and Personnel Department
Zip code
861-5598
Address
325 Izumimachi,Kita-ku,Kumamoto
TEL
096-275-2111
Homepage URL
kikaku@kumamoto-hsu.ac.jp
Sponsor or person
Institute
Kumamoto Health Science University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Health Science University
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
Kumamoto Health Science University Life Science Ethical Review Board
Address
325 Izumimachi,Kita-ku,Kumamoto
Tel
0962752111
kikaku@kumamoto-hsu.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 | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
Results
For maximum tongue pressure, the open-leg posture without a backrest showed significantly higher values than the closed-leg posture without a backrest for all subjects and for the male group. No significant differences were found between the postures for measurements of maximum bite force and muscle activity per unit of time in the suprahyoid muscles when drinking water. Maximum and total sitting pressure were significantly higher without a backrest than with a backrest.
Results date posted
| 2023 | Year | 03 | Month | 28 | Day |
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
| 2022 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 22 | 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 | 03 | Month | 28 | Day |
Last modified on
| 2023 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053623
