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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035363
Receipt No. R000039409
Official scientific title of the study Development of articulation training system for children with speech sound disorders
Date of disclosure of the study information 2019/01/04
Last modified on 2018/12/26

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Basic information
Official scientific title of the study Development of articulation training system for children with speech sound disorders
Title of the study (Brief title) 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 Yoshitaka Matsuura
Organization Kyoto University
Division name Department of Plastic and Reconstructive Surgery, Graduate School of Medicine, Kyoto University
Address Kyoto city,Sakyouku,Syogoin Kawaratyou 54
TEL 075-751-3613
Email ymatsuu@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person Kyoto University Hospital Consultation support center
Organization Kyoto University Hospital
Division name Consultation support center
Address Kyoto city,Sakyouku,Syogoin Kawaratyou 54
TEL 075-751-4748
Homepage URL
Email ctsodan@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 12 Month 28 Day
Anticipated trial start date
2019 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 12 Month 26 Day
Last modified on
2018 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039409

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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