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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032864
Receipt No. R000031762
Official scientific title of the study Effective examination of the swallow training that used the cervical interference pattern electrical stimulation for patients with dysphagia
Date of disclosure of the study information 2018/06/05
Last modified on 2018/06/04

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Basic information
Official scientific title of the study Effective examination of the swallow training that used the cervical interference pattern electrical stimulation for patients with dysphagia
Title of the study (Brief title) Effective examination of the swallow training that used the cervical interference pattern electrical stimulation
Region
Japan

Condition
Condition dysphasia
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For patients with dysphagia (head and neck tumor is postoperative cerebrovascular disorder, neuromuscular disorders), it examine whether there is efficacy of the swallow training that used cervical interference pattern electrical stimulation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The iteration saliva swallow number of times, time before the first occurring for saliva swallow, endoscopy, Videofluorography
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 The group which conducted the swallow training group which used cervical interference pattern electrical stimulation/ only swallw training group
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients with dysphagia within three months after the onset that consulted University of Ryukyu otolaryngology after this study approval for a period of ... March, 2019 (head and neck tumor is postoperative cerebrovascular disorder, neuromuscular disorders).
Key exclusion criteria "2011 for adverse event codialect criteria V4.0 Japanese edition JCOG/LSCO" (an abbreviated designation:)
The case with the aspiration symptom of respiratory apparatus grade 3 or more of CTCAE v4.0-JCOG), a chest and mediastinal disorders.
(2)
It is the case with a wound or the rash to cervical skin.
(3)
A case to be found of severe cognitive impairment.
(4)
A case with a pacemaker, the cochlear implant.
(5)
The case that we cannot report it to whether we felt it for electricity.
Target sample size 9

Research contact person
Name of lead principal investigator Asanori Kiyuna
Organization University of the Ryukyus
Division name Graduate school of medicine, otolaryngology-head and neck suegery
Address 207 Uehara, Nishihara-cho, Okinawa, Japan
TEL 0988951183
Email asanori@med.u-ryukyu.ac.jp

Public contact
Name of contact person Asanori Kiyuna
Organization University of the Ryukyus
Division name Graduate school of medicine, otolaryngology-head and neck suegery
Address 207 Uehara, Nishihara-cho, Okinawa, Japan
TEL 0988951183
Homepage URL
Email asanori@med.u-ryukyu.ac.jp

Sponsor
Institute University of the Ryukyus
Institute
Department

Funding Source
Organization KAKENHI
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 06 Month 05 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 12 Day
Anticipated trial start date
2017 Year 10 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 04 Day
Last modified on
2018 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031762

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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