UMIN-CTR Clinical Trial

Basic information
Public title	Influence of speech rate on tongue and palate contact in Japanese language -Experimental research using electropalatography-
Acronym	Influence of speech rate on tongue and palate contact in Japanese language -Experimental research using electropalatography-
Scientific Title	Influence of speech rate on tongue and palate contact in Japanese language -Experimental research using electropalatography-
Scientific Title:Acronym	Influence of speech rate on tongue and palate contact in Japanese language -Experimental research using electropalatography-
Region	Japan

Condition
Condition	healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we investigate the relationship between vowel and consonant types and utterance speed in Japanese language lines using EPG. The purpose of this study is to extract the change in tongue and palate contact caused by changing the speech rate by uttering the vowels in combination with the vowels, and to analyze the movement of the tongue during articulation.
Basic objectives2	Others
Basic objectives -Others	Change of tongue motion during articulation due to change of speech speed is clarified.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	EPG data
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Produce words 5 times and record voice and EPG data.
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) Those who speak their mother tongue in Japanese 2) Person who possesses certain knowledge about pronunciation and can perform subjective control 3) In cooperation with research cooperation, you can express your intention to research cooperation by yourself, those who obtain written consent with free will of the target
Key exclusion criteria	1) Persons with trauma in the oral cavity
Target sample size	3

Research contact person
Name of lead principal investigator	1st name shohei Middle name Last name okumura
Organization	Social Medical Corporation Kotobuki Tominaga Hospital
Division name	Rehabilitation department
Zip code	556-0017
Address	1-4-48 Minatomachi, Naniwa-ku, Osaka-shi
TEL	06-6568-1608
Email	okumurajanaiyo@gmail.com

Public contact
Name of contact person	1st name shohei Middle name Last name okumura
Organization	Social Medical Corporation Kotobuki Tominaga Hospital
Division name	Rehabilitation department
Zip code	556-0017
Address	1-4-48 Minatomachi, Naniwa-ku, Osaka-shi
TEL	06-6568-1608
Homepage URL
Email	okumurajanaiyo@gmail.com

Sponsor
Institute	Social Medical Corporation Kotobuki Tominaga Hospital
Institute
Department

Funding Source
Organization	Social Medical Corporation Kotobuki Tominaga Hospital
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	Social Medical Corporation Kotobuki Tominaga Hospital
Address	1-4-48 Minatomachi, Naniwa-ku, Osaka-shi
Tel	0665681608
Email	okumurajanaiyo@gmail.com

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	2019 Year 12 Month 29 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	3
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	2019 Year 08 Month 13 Day
Date of IRB	2019 Year 08 Month 13 Day
Anticipated trial start date	2019 Year 08 Month 13 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 12 Month 29 Day
Last modified on	2020 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044509