UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059526 |
|---|---|
| Receipt number | R000068092 |
| Scientific Title | Effect of exercise using a pharyngeal contraction training tool |
| Date of disclosure of the study information | 2025/10/24 |
| Last modified on | 2025/10/24 09:36:14 |
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Basic information
Public title
Effect of exercise using a sRED
Acronym
sRED-E
Scientific Title
Effect of exercise using a pharyngeal contraction training tool
Scientific Title:Acronym
Effect of a pharyngeal contraction training tool
Region
| Japan |
Condition
Condition
Dysphagia due to insufficient contraction of the pharyngeal constrictor muscles during swallowing
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the training effect of using a pharyngeal contraction training tool for patients with dysphagia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in a penetration-aspiration scale before and after the training
Key secondary outcomes
1) Results of videofluoroscopy, videoendoscopy, and manometry examinations
2) Tongue pressure
3) Record of training frequency achieved
4) Adverse events
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
| Device,equipment |
Interventions/Control_1
With the sRED wrapped around the neck, inflate the balloon to compress the thyroid cartilage, and the patients perform swallowing. If the patients cannot swallow due to lack of saliva, inject a small amount of a safe liquid or thickened water into the mouth and attempt swallowing. The patients perform the training 1-3 sets per day; each set consists of 30 swallows.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older with dysphagia and insufficient contraction of the pharyngeal constrictor muscles during swallowing
Key exclusion criteria
1) Patients who cannot adequately follow the therapist's instructions due to cognitive impairment or higher brain dysfunction
2) Patients with malignant tumors at the application site
3) Patients with skin abnormalities such as eczema or trauma at the throat area
4) Patients unable to recognize throat pain, discomfort, breathing abnormalities, or blood flow abnormalities
5) Patients with allergic symptoms to natural rubber
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kagaya |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation Medicine
Zip code
474-8511
Address
7-430 Morioka-cho, Obu, Aichi
TEL
0562-46-2311
hkagaya2@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kagaya |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation Medicine
Zip code
474-8511
Address
7-430 Morioka-cho, Obu, Aichi
TEL
0562-46-2311
Homepage URL
hkagaya2@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Review Board, National Center for Geriatric and Gerontology
Address
7-430 Morioka-cho, Obu, Aichi
Tel
0562-46-2311
yaday@ncgg.go.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 | 10 | Month | 24 | 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
| 2025 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 24 | 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 | 10 | Month | 24 | Day |
Last modified on
| 2025 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068092
