UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034271 |
|---|---|
| Receipt number | R000036130 |
| Scientific Title | Jaw openging exercise effect swallowing function and architect of supahyoid muscle: A randomized control study |
| Date of disclosure of the study information | 2018/09/26 |
| Last modified on | 2018/09/26 11:53:32 |
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Basic information
Public title
Jaw openging exercise effect swallowing function and architect of supahyoid muscle: A randomized control study
Acronym
The effect of Jaw opening exercise on the supra hyoid muscle
Scientific Title
Jaw openging exercise effect swallowing function and architect of supahyoid muscle: A randomized control study
Scientific Title:Acronym
The effect of Jaw opening exercise on the supra hyoid muscle
Region
| Japan |
Condition
Condition
form light to mild dysphagia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Jaw-openig exercise (JOE) has been reported that it improved the swallowing function and hyoid movement during swallowing. However, It is unknown if JOE effects to increase the volume and quality of the supra hyoid muscle. This study aim to clarify how JOE effect the architect of sprahyoid muscle on a randomized control study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
volume, quality and strength of suprahyoid muscle
Key secondary outcomes
hyoid elevation, nutritional status, swallowing function, meaning time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Jaw-opning exercise and regularly evaluation of swallowing function
Interventions/Control_2
regularly evaluation of swallowing function
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
Agreement of taking part in this study.
Be able to undersand the instruction by the trainer.
No sever general condition
Key exclusion criteria
Less than the level 4 of FOIS(Functional oral intake scale). Having neural muscular disease. Having bulbar palsy.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Hara |
Organization
Graduate School of Medical and Dental Sciences,
Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology,
Zip code
Address
1-5-45, Yushima, Bunkyo, Tokyo 113-8549, JAPAN
TEL
03-5803-5562
koji19831031@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Hara |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology,
Zip code
Address
1-5-45, Yushima, Bunkyo, Tokyo 113-8549, JAPAN
TEL
03-5803-5562
Homepage URL
koji19831031@gmail.com
Sponsor or person
Institute
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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
| 2018 | Year | 09 | Month | 26 | 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
In intervention group, the are of muscle (MA) of geniohyoid muscle has increased significantly after intervention period, while MA of geniohyoid has decreased significantly after intervention period.
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
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 08 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 22 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 28 | Day |
Other
Other related information
BMI in both group decreased after 3month follow up.
Management information
Registered date
| 2018 | Year | 09 | Month | 26 | Day |
Last modified on
| 2018 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036130
