UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of tongue pressure and suprahyoid muscles activity during tongue elevation using hanging scale in patients with and without decreased tongue pressure.
Title of the study (Brief title)	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	Kazuhisa Domen
Organization	Hyogo collage of medicine
Division name	Department of rehabilitation
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL	0798-45-6644
Email	office@craseed.org

Public contact
Name of contact person	Tomoki Nanto
Organization	Hospital of Hyogo College of Medicine
Division name	Department of physical medicine and rehabilitation
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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