UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027942 |
|---|---|
| Receipt number | R000032005 |
| Scientific Title | The effect of the new developed dysphagia rehabilitation by using jaw-opening movement |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2017/06/26 17:34:39 |
* 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
The effect of the new developed dysphagia rehabilitation by using jaw-opening movement
Acronym
Jawo-openig movement for Dysphagia
Scientific Title
The effect of the new developed dysphagia rehabilitation by using jaw-opening movement
Scientific Title:Acronym
Jawo-openig movement for Dysphagia
Region
| Japan |
Condition
Condition
the elderly that has complain of dysphagia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The strength of supra-hyoid muscles decline in aging. It results in insufficient upper esophageal sphincter opening which cause aspiration. The aim of this study is to valid the effect of jaw opening movement as dysphagia rehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The width of upper esophageal sphincter openin
Key secondary outcomes
The magnitude and velocity of hyoid bone
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
| Maneuver |
Interventions/Control_1
Jaw-opening exercise for a month. They have to exercise it every day.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subject who is able to follow an instruction and has agreed with participating this research.
Key exclusion criteria
The subject who can not communicate, such as dementia.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruka Tohara |
Organization
Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences,
Zip code
Address
1-5-45, Yushima, Bunkyo, Tokyo 113-8549, JAPAN
TEL
0358035562
haruka-t@rd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Hara |
Organization
Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate Schoo
Zip code
Address
1-5-45, Yushima, Bunkyo, Tokyo 113-8549, JAPAN
TEL
0358035562
Homepage URL
koji19831031@gmail.com
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 01 | 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
| 2016 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 05 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 06 | Day |
Date analysis concluded
| 2017 | Year | 10 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 26 | Day |
Last modified on
| 2017 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032005
