UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000021438
Receipt No. 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 (Ver. 6)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

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
Email 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
Email kobayuu1@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024723