UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035363 |
|---|---|
| Receipt number | R000039409 |
| Scientific Title | Development of articulation training system for children with speech sound disorders |
| Date of disclosure of the study information | 2019/01/04 |
| Last modified on | 2021/06/28 18:14:57 |
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Basic information
Public title
Development of articulation training system for children with speech sound disorders
Acronym
Development of articulation training system
Scientific Title
Development of articulation training system for children with speech sound disorders
Scientific Title:Acronym
Development of articulation training system
Region
| Japan |
Condition
Condition
Velopharyngeal insufficiency (congenital or due to cleft palate)
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop and evaluate software as a supportive tool in speech and language therapy for the treatment of children with phonologically based speech sound disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intelligibility score in speaking monosyllables and single words
Key secondary outcomes
Number of iterations to improve speech intelligibility
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
The software-installed tablet computer that shows the instruction of speech and language pathologist is used for 3 months at home in practicing the speech.
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
| 3 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Mild velopharyngeal insufficiency.
2. Moderate to severe speech sound disorder.
Key exclusion criteria
Mental retardation
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Matsuura |
Organization
Kyoto University
Division name
Department of Plastic and Reconstructive Surgery, Graduate School of Medicine, Kyoto University
Zip code
Address
Kyoto city,Sakyouku,Syogoin Kawaratyou 54
TEL
075-751-3613
ymatsuu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyoto University Hospital Consultation support center |
Organization
Kyoto University Hospital
Division name
Consultation support center
Zip code
Address
Kyoto city,Sakyouku,Syogoin Kawaratyou 54
TEL
075-751-4748
Homepage URL
ctsodan@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Meijiyasudaseimei Mental Health Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 04 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 26 | Day |
Last modified on
| 2021 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039409
