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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000027942 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | the elderly that has complain of dysphagia | |
Classification by specialty |
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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 |
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Interventions/Control_1 | Jaw-opening exercise for a month. They have to exercise it every day. | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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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 | |
Institute | Tokyo Medical and Dental University |
Institute | |
Department |
Funding Source | |
Organization | Japan society for the promotion of science |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization | Japan |
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IRB Contact (For public release) | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Other | |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032005 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |