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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047658
Receipt No. R000054342
Scientific Title Analysis of the effect of muscle activity distribution on muscle mass and function during training of swallowing-related muscles using a parallel group comparison study.
Date of disclosure of the study information 2022/05/13
Last modified on 2022/05/06

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Basic information
Public title A study to investigate the effect of the distribution of activity within muscles on muscle mass and function during the training muscles related to chewing and swallowing.
Acronym A study to investigate the relationship between activity and function in the training of muscles related to chewing and swallowing.
Scientific Title Analysis of the effect of muscle activity distribution on muscle mass and function during training of swallowing-related muscles using a parallel group comparison study.
Scientific Title:Acronym Analysis of the effect of muscle activity distribution on muscle mass and function during training of swallowing-related muscles.
Region
Japan

Condition
Condition Dysphagia
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the relationship between the distribution of activity in swallowing-related muscles during various training exercises and changes in muscle volume and swallowing-related functions in healthy subjects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship between the distribution of activity within relevant muscles during training exercise and muscle volume and related functions after 4 weeks of training.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 Tongue pressure measuring probe placed 10 mm posterior to the apex of the tongue and press it against the palate (4 weeks).
Interventions/Control_2 Place the probe near the terminal sulcus of tongue and press it against the palate (4 weeks).
Interventions/Control_3 Pressing the probe attached to the bite plate on the anterior teeth with the lingual apex (4 weeks).
Interventions/Control_4 Probes attached to bite plates on left and right molars pressed with lingual edges (4 weeks).
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Healthy normal volunteers through open recruitment
(2)Age 20 years or older (at the time of registration)
Key exclusion criteria (1) Participants with obvious functional abnormalities in the jaw and oral system.
(2) Participants with pain originating from teeth or periodontal tissue, or diseases related to nerves, muscles, or metabolism.
(3) Participants with contraindications to MRI.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Yamaguchi
Organization Tohoku University
Division name Hospital
Zip code 980-8575
Address 4-1, Seiryo-machi, Aoba-ku, Sendai-city, Miyagi, Japan
TEL 0227178396
Email satoshi.yamaguchi.a3@tohoku.ac.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Yamaguchi
Organization Tohoku University
Division name Hospital
Zip code 980-8575
Address 4-1, Seiryo-machi, Aoba-ku, Sendai-city, Miyagi, Japan
TEL 0227178396
Homepage URL
Email satoshi.yamaguchi.a3@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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 Tohoku University Graduate School of Dentistry
Address 4-1, Seiryo-machi, Aoba-ku, Sendai-city, Miyagi, Japan
Tel 0227178396
Email satoshi.yamaguchi.a3@tohoku.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
2022 Year 05 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
2022 Year 04 Month 04 Day
Date of IRB
Anticipated trial start date
2022 Year 06 Month 01 Day
Last follow-up date
2026 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
2022 Year 05 Month 06 Day
Last modified on
2022 Year 05 Month 06 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054342

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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