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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044478
Receipt No. R000050806
Scientific Title Effects of interferential current stimulation on the swallowing reflex
Date of disclosure of the study information 2021/06/10
Last modified on 2021/06/09

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Basic information
Public title Effects of interferential current stimulation on the swallowing reflex
Acronym Effects of interferential current stimulation on the swallowing reflex
Scientific Title Effects of interferential current stimulation on the swallowing reflex
Scientific Title:Acronym Effects of interferential current stimulation on the swallowing reflex
Region
Japan

Condition
Condition dysphagia
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether interferential current stimulation of the neck is effective in stimulating the swallowing reflex in healthy adults and patients with dysphagia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Repetitive saliva swallowing test before, during, and after stimulation
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Interferential current stimulation from neck
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

Not applicable
Gender Male and Female
Key inclusion criteria a) Healthy adults
Adults aged 20 years or older who have no history of stroke, neuromuscular disease, or cardiac disease and who can provide informed consent for this study.
b) Patients with dysphagia
Patients 20 years of age or older who are suspected of dysphagia by screening tests and who have given informed consent for this study.
Key exclusion criteria a)
Previous history of pharyngeal or laryngeal disease, respiratory disease, or upper gastrointestinal disease
b)
Patients who are unable to follow instructions for saliva swallowing due to impaired consciousness or impaired cognitive function. Other patients who are judged inappropriate by the principal investigator or sub-investigators.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yohei
Middle name
Last name Otaka
Organization Fujita Health University
Division name Department of Rehabilitation Medicine I, School of Medicine
Zip code 470-1192
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL 0562-93-2167
Email rehabmed@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Mao
Middle name
Last name Ogawa
Organization Fujita Health University
Division name Department of Rehabilitation Medicine I, School of Medicine
Zip code 470-1192
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL 0562-93-2167
Homepage URL
Email ogawa111@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

Funding Source
Organization Ministry of education
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 Fujita Health University
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
Tel 0562-93-2167
Email rehabmed@fujita-hu.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 藤田医科大学病院(愛知県)
豊田地域医療センター(愛知県)

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 10 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 Enrolling by invitation
Date of protocol fixation
2021 Year 05 Month 14 Day
Date of IRB
2021 Year 05 Month 14 Day
Anticipated trial start date
2021 Year 06 Month 15 Day
Last follow-up date
2023 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
2021 Year 06 Month 09 Day
Last modified on
2021 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050806

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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