UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024914
Receipt number 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 05:29:13

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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 or person

Institute

Hospital of Hyogo College of Medicine

Institute

Department

Personal name



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

Value
https://center6.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