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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020399
Receipt No. R000023535
Scientific Title Evaluation of voluntary tongue lift movement
Date of disclosure of the study information 2015/12/29
Last modified on 2015/12/29

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Basic information
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
Condition Dysphagia
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization Okayama University
Organization
Division
Category of Funding Organization
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 岡山大学病院(岡山県)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 29 Day

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
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
Other related information

Management information
Registered date
2015 Year 12 Month 29 Day
Last modified on
2015 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023535

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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