UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013139 |
|---|---|
| Receipt number | R000015320 |
| Scientific Title | Examination of the effectivenes of swallowing training using the ballon type manometory |
| Date of disclosure of the study information | 2014/02/13 |
| Last modified on | 2014/09/18 12:24:11 |
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Basic information
Public title
Examination of the effectivenes of swallowing training using the ballon type manometory
Acronym
swallowing training effect using ballon type manometry
Scientific Title
Examination of the effectivenes of swallowing training using the ballon type manometory
Scientific Title:Acronym
swallowing training effect using ballon type manometry
Region
| Japan |
Condition
Condition
dysphagics
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to examine the effectiveness of the swallowing training to increase the swallowing pressure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
swallowing pressure in pharynx
Key secondary outcomes
Base
Study type
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
Swallowing maneuver to increase swallowing pressure in pharynx
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
dysphagic patients detected by Videofluoroscopy
Key exclusion criteria
cognitive disorders (less than 20 by HDS-R)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kikuo Ota |
Organization
International University of Health and Welfare Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
537-3 Iguchi Nasushiobara, Tochigi, JAPAN
TEL
0287-39-3060
rkota@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuko Yoshinari |
Organization
International University of Health and Welfare Hospital
Division name
General Affairs and Planning Section
Zip code
Address
537-3 Iguchi Nasushiobara, Tochigi, JAPAN
TEL
0287-39-3060
Homepage URL
hp.kokufuku@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
国際医療福祉大学病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 12 | Day |
Last modified on
| 2014 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015320
| 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 |
