UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032864 |
|---|---|
| Receipt number | R000031762 |
| Scientific Title | 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 | 2020/06/08 14:10:54 |
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Basic information
Public title
Effective examination of the swallow training that used the cervical interference pattern electrical stimulation for patients with dysphagia
Acronym
Effective examination of the swallow training that used the cervical interference pattern electrical stimulation
Scientific Title
Effective examination of the swallow training that used the cervical interference pattern electrical stimulation for patients with dysphagia
Scientific Title:Acronym
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
| 1st name | Asanori |
| Middle name | |
| Last name | Kiyuna |
Organization
University of the Ryukyus
Division name
Graduate school of medicine, otolaryngology-head and neck suegery
Zip code
9030215
Address
207 Uehara, Nishihara-cho, Okinawa, Japan
TEL
0988951183
asanori@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Asanori |
| Middle name | |
| Last name | Kiyuna |
Organization
University of the Ryukyus
Division name
Graduate school of medicine, otolaryngology-head and neck suegery
Zip code
9030215
Address
207 Uehara, Nishihara-cho, Okinawa, Japan
TEL
0988951183
Homepage URL
asanori@med.u-ryukyu.ac.jp
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
University of the Ryukyus
Address
207 Uehara, Nishihara-cho, Okinawa, Japan
Tel
0988953331
asanori@med.u-ryukyu.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 05 | 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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2020 | 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
| 2018 | Year | 06 | Month | 04 | Day |
Last modified on
| 2020 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031762
| 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 |
