UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060969 |
|---|---|
| Receipt number | R000069769 |
| Scientific Title | Preliminary Study of DSAS(dry swallow after suction)for Dysphagia with Velopharyngeal Insufficiency After Stroke. |
| Date of disclosure of the study information | 2026/03/17 |
| Last modified on | 2026/03/17 22:30:16 |
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Basic information
Public title
Preliminary Study of DSAS(dry swallow after suction)for Dysphagia
with Velopharyngeal Insufficiency After Stroke.
Acronym
Preliminary Study of DSAS(dry swallow after suction)for Dysphagia
with Velopharyngeal Insufficiency After Stroke.
Scientific Title
Preliminary Study of DSAS(dry swallow after suction)for Dysphagia
with Velopharyngeal Insufficiency After Stroke.
Scientific Title:Acronym
Preliminary Study of DSAS(dry swallow after suction)for Dysphagia
with Velopharyngeal Insufficiency After Stroke.
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy of DSAS training by practicing it on multiple cases of dysphagia with velopharyngeal insufficiency after stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Posterior and superior displacement of the velar knee.
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Implementation of Dry Swallow After Suction (DSAS) Training in a Stroke Patient with Velopharyngeal Insufficiency During Swallowing
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
(1)The maximum expiration time(MET)is 10 seconds or longer.
(2)Patients capable of voluntarily swallowing saliva
(3)Patients who retain the cognitive function necessary to understand the DSAS procedure
Key exclusion criteria
(1)Patients with tachypnea(respiratory rate of 25 breaths per minute or more).
(2)Patients with suspected aspiration based on the water-drinking test.
(3)Patients with comorbid conditions that cause progressive dysphagia.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Takeda |
Organization
Tokai University Hachioji Hospital
Division name
Rehabilitation Technology Department
Zip code
192-0032
Address
1838 Ishikawa-cho, Hachioji, Tokyo
TEL
0570-000-802
takeda.daisuke@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Takeda |
Organization
Tokai University Hachioji Hospital
Division name
Rehabilitation Technology Department
Zip code
192-0032
Address
1838 Ishikawa-cho, Hachioji, Tokyo
TEL
0570-000-802
Homepage URL
takeda.daisuke@tokai.ac.jp
Sponsor or person
Institute
Tokai University Hachioji Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokai University Hachioji Hospital
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
Tokai University Hachioji Hospital
Address
1838 Ishikawa-cho, Hachioji, Tokyo
Tel
0570-000-802
takeda.daisuke@tokai.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
東海大学医学部付属八王子病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2029 | Year | 08 | 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
| 2026 | Year | 03 | Month | 17 | Day |
Last modified on
| 2026 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069769
