UMIN-CTR Clinical Trial

Basic information
Public title	Intervention study on improvement of the voice articulation with an artificial tongue.
Acronym	Study on improvement of the voice articulation with an artificial tongue.
Scientific Title	Intervention study on improvement of the voice articulation with an artificial tongue.
Scientific Title:Acronym	Study on improvement of the voice articulation with an artificial tongue.
Region	Japan

Condition
Condition	tongue resection or tongue movement disorders
Classification by specialty	Oto-rhino-laryngology Plastic surgery Dental medicine Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the improvement of the voice articulation by the speech that is corrected based on the frequency analysis of the speech under the condition which tongue movement is limited by an artificial tongue.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation by the speech intelligibility test for the improvement of the voice articulation by the speech that is corrected based on the frequency analysis of the speech under the condition which tongue movement is limited by an artificial tongue.
Key secondary outcomes	Evaluation of effect on the frequency characteristics of the voice with the presence or absence of the artificial tongue.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	An articulation aiding system by an analysis of the frequency of the speech
Interventions/Control_2	Inhibition of tongue movement
Interventions/Control_3	Normal
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	18 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) There is no disease under treatment, there is no taking drug
Key exclusion criteria	1) Having a history of articulation disorder. 2) Using a denture.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shigehisa Kawakami
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
TEL	086-235-6687
Email	s-kawa-10@t.okadai.jp

Public contact
Name of contact person	1st name Middle name Last name Shigehisa Kawakami
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
TEL	086-235-6687
Homepage URL
Email	s-kawa-10@t.okadai.jp

Sponsor
Institute	Department of Occlusal and Oral Functional Rehabilitation, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Institute
Department

Funding Source
Organization	Department of Occlusal and Oral Functional Rehabilitation, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Graduate School of Natural Science and Technology, Okayama University
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（岡山県）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 25 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 04 Month 25 Day
Date of IRB	2016 Year 06 Month 01 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date	2018 Year 03 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	2016 Year 04 Month 25 Day
Last modified on	2022 Year 01 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025416