UMIN-CTR Clinical Trial

Public title

Evaluation of voluntary tongue lift movement

Acronym

Evaluation of voluntary tongue lift movement

Scientific Title

Evaluation of voluntary tongue lift movement

Scientific Title:Acronym

Evaluation of voluntary tongue lift movement

Region

Japan

Condition

Dysphagia

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We have developed a new modality that enabled to detect and visualize the posterior tongue lift movement which it was difficult to observe and evaluate in usual method.
The purpose of this study was to elucidate the tongue lifting function, especially in the posterior part to the tongue by the device we developed.

Basic objectives2

Others

Basic objectives -Others

Dynamic property of the posterior part of tongue

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Following 5 parameters calculated from the data about trajectories of posterior tongue surface;
(1) maximum upward velocity (MUV)(mm/s)
(2) range of tongue lift (TLift)(mm)
(3) distance from palate to uppermost point of tongue (P-T)(mm)
(4) duration from the beginning of the movement to the maximum attainment point (D)(s)
(5) maximum downward velocity (MDV)(mm/s)

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

1. Basic measurement of movement of posterior tongue
Subjects were seated in an upright position and instructed the following tasks;
1) effortful swallowing
2) phonation

2. Measurement of movement of posterior tongue in various posture
Subjects were seated in the following 4 posture. In each posture, movement of posterior tongue was measured with a neck rotated 15 degrees to the right, 0 degree and 15 degrees to the left.
1) upright position
2) 30 degrees face up position
3) 60 degrees face up position
4) 120 degrees face up position

Ten repetitive trials were conducted above all conditions.

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Healthy Adult (more than 20 years old)
2) The person who did not have subjective difficulties in swallowing or food intake
3) The person who was diagnosed as there being no doubt of aspiration by swallowing test.

Key exclusion criteria

The person who was suspected to have aspiration

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Shogo Minagi

Organization

Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama University

Division name

Department of Occlusal and Oral Functional Rehabilitation

Zip code

Address

2-5-1 Shikata-cho, Kita-ku, Okayama, Japan

TEL

086-235-6687

Email

minagi@md.okayama-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Kazuhiro Oki

Organization

Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama University

Division name

Department of Occlusal and Oral Functional Rehabilitation

Zip code

Address

2-5-1 Shikata-cho, Kita-ku, Okayama, Japan

TEL

086-235-6687

Homepage URL

Email

kazu_z@md.okayama-u.ac.jp

Institute

Okayama University

Institute

Department

Personal name

Organization

Okayama University

Organization

Division

Category of Funding Organization

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

岡山大学病院（岡山県）

Date of disclosure of the study information

2015

Year

12

Month

29

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Twenty-three healthy volunteers (9 men and 14 women; mean age, 27.6 years) participated in this study. A new device was developed that could evaluate the up-down movement of the posterior part of the tongue in a non-invasive manner.
The experimental tasks were as follows: (i) /a/ pronunciation for 1 s followed by /ka/ pronunciation (a-ka task), (ii) /a/ pronunciation for 1 s followed by /ga/ pronunciation (a-ga task) and (iii) /a/ pronunciation for 1 s followed by a voluntary push-up movement of the posterior part of the tongue (a-lift task).
Maximum upward velocity in the a-ga task was larger than that in the a-ka task (P < 0.05). The a-lift task showed the highest tongue lift range among the three tasks, and the a-ga task showed a higher range than that of the a-ka task (P < 0.05).
This study revealed that precise quantification of the motility of the posterior part of the tongue, which would be useful in rehabilitation of articulation and/or swallowing, could be achieved using this new device in a non-invasive manner.

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

2010

Year

06

Month

24

Day

Date of IRB

Anticipated trial start date

2010

Year

07

Month

28

Day

Last follow-up date

2011

Year

03

Month

31

Day

Date of closure to data entry

2011

Year

03

Month

31

Day

Date trial data considered complete

2011

Year

03

Month

31

Day

Date analysis concluded

2011

Year

03

Month

31

Day

Other related information

Registered date

2015

Year

12

Month

29

Day

Last modified on

2015

Year

12

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023535