UMIN-CTR Clinical Trial

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

Patients with and without decreased tongue pressure

Classification by specialty

Rehabilitation medicine

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Hospital of Hyogo College of Medicine

Institute

Department

Personal name

Organization

Japanese Association of Speech-Language-Hearing Therapists

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

11

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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