UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022046 |
|---|---|
| Receipt number | 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 | 2022/01/17 10:12:58 |
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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
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
s-kawa-10@t.okadai.jp
Sponsor or person
Institute
Department of Occlusal and Oral Functional Rehabilitation, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025416
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
