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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022046
Receipt No. R000025416
Scientific Title Intervention study on improvement of the voice articulation with an artificial tongue.
Date of disclosure of the study information 2016/04/25
Last modified on 2016/04/25

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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 Preinitiation
Date of protocol fixation
2016 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
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
2016 Year 04 Month 25 Day


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

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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