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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036682
Receipt No. R000041781
Scientific Title Relationship between maximum retention and oral function
Date of disclosure of the study information 2019/07/01
Last modified on 2019/11/18

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Basic information
Public title Relationship between maximum retention and oral function
Acronym Relationship between maximum retention and oral function
Scientific Title Relationship between maximum retention and oral function
Scientific Title:Acronym Relationship between maximum retention and oral function
Region
Japan

Condition
Condition patients 60 years of age and older
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Hematology and clinical oncology Nephrology Neurology
Clinical immunology Infectious disease Geriatrics
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Vascular surgery Chest surgery Endocrine surgery
Oto-rhino-laryngology Orthopedics Urology
Oral surgery Neurosurgery Cardiovascular surgery
Emergency medicine Intensive care medicine Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to clarify the relationship between the maximum force that can hold the gauze in the tongue and palate, the maximum tongue pressure, the tongue lateral movement, oral diadochonexiasis, and the tongue pressure during swallowing, and the maximum retention force is the oral cavity. It is to clarify that it is an index that reflects the function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Maximum retention( Maximum power to hold the gauze in the tongue and palate )
Key secondary outcomes Maximum tongue pressure value measured by JMS
The tongue pressure value of the saliva effort swallowing measured by Swallowscan
Acoustic analysis of Oral Diadochokinesis
Left and right repetitive movement of the tongue

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
Device,equipment
Interventions/Control_1 Oral Function Deterioration Group (Utanohara et al. Maximum age-specific tongue pressure below average)
Oral function normal group (Utanohara et al. Age-specific maximum tongue pressure is above average)

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
60 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Patients aged 60 or older in Hyogo College Of Medicine Hospital. Patients who is able to understand instructions of opening mouth, tongue thrust and tongue elevation. Patients whose blood pressure, heart rate and oxygen saturation are below the required standards for rehabilitation at rest, during and after exercise.
Key exclusion criteria Structural disorder of the palate, tongue, jaw. Patients with dementia, aphasia, severe dysphagia, oral musitis and gingival recession.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kazuhisa
Middle name
Last name Domen
Organization Hyogo collage of medicine
Division name Department of rehabilitation
Zip code 663-8501
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6644
Email office@craseed.org

Public contact
Name of contact person
1st name Kohei
Middle name
Last name Horikawa
Organization Hospital of Hyogo College of Medicine
Division name Department of physical medicine and rehabilitation
Zip code 663-8501
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6345
Homepage URL
Email ko-horikawa@hyo-med.ac.jp

Sponsor
Institute Hospital of Hyogo College of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hyogo Medical University Clinical Research Support Center
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
Tel 0798456006
Email chiken02@hyo-med.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
2019 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 No longer recruiting
Date of protocol fixation
2019 Year 08 Month 01 Day
Date of IRB
2019 Year 11 Month 12 Day
Anticipated trial start date
2019 Year 08 Month 02 Day
Last follow-up date
2022 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
2019 Year 05 Month 08 Day
Last modified on
2019 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041781

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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