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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name