UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021438 |
|---|---|
| Receipt number | R000024723 |
| Scientific Title | Effects of supraglottic swallow and forehead exercise in swallowing function |
| Date of disclosure of the study information | 2016/03/18 |
| Last modified on | 2019/10/19 11:15:23 |
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Basic information
Public title
Effects of supraglottic swallow and forehead exercise in swallowing function
Acronym
Physiological evaluation of swallowing exercises
Scientific Title
Effects of supraglottic swallow and forehead exercise in swallowing function
Scientific Title:Acronym
Physiological evaluation of swallowing exercises
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Medicine in general | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We monitor swallows before and after the supraglottic swallow and the 'forehead exercise', and evaluate whether or not these maneuvers are effective.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Coordination between swallowing and respiration
Key secondary outcomes
Pharyngeal response duration
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
supraglottic swallow, twice, and forehead exercise, twice.
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
Chronic stable patients with dysphasia with FILS level 4-8.
Key exclusion criteria
Patients with severe dementia who cannot follow the instructions of swallowing maneuvers.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Oku |
Organization
Hyogo College of Medicine
Division name
Department of Physiology
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6385
yoku@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichiro Kobayashi |
Organization
Hyogo College of Medicine
Division name
Department of Research Cooperation
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL
0798-45-6164
Homepage URL
kobayuu1@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Foodcare Co., Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hamamatsu City Rehabilitation Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
浜松市リハビリテーション病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 18 | Day |
Related information
URL releasing protocol
https://austinpublishinggroup.com/physical-medicine/fulltext/pmr-v4-id1132.php
Publication of results
Published
Result
URL related to results and publications
https://austinpublishinggroup.com/physical-medicine/fulltext/pmr-v4-id1132.php
Number of participants that the trial has enrolled
30
Results
None of the parameters associated with swallowing kinetics showed significant changes during the two maneuvers. The humming swallow maneuver may increase the frequency of inspiration after swallow, so caution should be exercised when this technique is applied to patients with food residues in the pharynx.
Results date posted
| 2019 | Year | 10 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
dysphagia patients
Participant flow
Patient performed the humming swallow and the forehead exercise sequentially.
Adverse events
None.
Outcome measures
Swallowing kinetics and breathing-swallowing coordination
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 11 | Day |
Last modified on
| 2019 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024723
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
