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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024914
Receipt No. R000026832
Scientific Title Investigation of tongue pressure and suprahyoid muscles activity during tongue elevation using hanging scale in patients with and without decreased tongue pressure.
Date of disclosure of the study information 2016/11/20
Last modified on 2017/07/07

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Basic information
Public title Investigation of tongue pressure and suprahyoid muscles activity during tongue elevation using hanging scale in patients with and without decreased tongue pressure.
Acronym Investigation of tongue elevation using hanging scale -tongue pressure and suprahyoid muscles activity-
Scientific Title Investigation of tongue pressure and suprahyoid muscles activity during tongue elevation using hanging scale in patients with and without decreased tongue pressure.
Scientific Title:Acronym Investigation of tongue elevation using hanging scale -tongue pressure and suprahyoid muscles activity-
Region
Japan

Condition
Condition Patients with and without decreased tongue pressure
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Revealing tongue pressure pattern and suprahyoid muscle activity in tongue elevation using hanging scale and obtaining basic knowledge for development of tongue pressure training.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Relationship between maximum tongue pressure measured by JMS tongue pressure measurement and tongue holding force measured by hanging scale
Key secondary outcomes 1) measurement error of tongue holding force
2) Effects of difference in gauze shape on tongue pressure
3) Effects of tractive force of hanging scale on tongue pressure and suprahyoid muscle activity

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 1 Measuring maximum tongue holding force using hanging scale with three repetition for patients with and without decreased tongue pressure
2 Traction of hanging scale with 25 percent, 50 percent, 75 percent and 100 percent of maximum tongue holding force with one repetition for patients with decreased tongue pressure
3 Traction of hanging scale with 50 gf, 100 gf, 150 gf and 200 gf with one repetition for patients with decreased tongue pressure
4 Traction of hanging scale with median condition, lateral condition, anterior condition and posterior condition of gauze form with one repetition for patients with decreased tongue pressure
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
50 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Patients aged 50 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. Tongue deviation in tongue thrusting caused by brain damage. 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
Middle name
Last name Kazuhisa Domen
Organization Hyogo collage of medicine
Division name Department of rehabilitation
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6644
Email office@craseed.org

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

Sponsor
Institute Hospital of Hyogo College of Medicine
Institute
Department

Funding Source
Organization Japanese Association of Speech-Language-Hearing Therapists
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 11 Month 20 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 Completed
Date of protocol fixation
2016 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 20 Day
Last modified on
2017 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026832

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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