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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034841
Receipt No. R000039720
Scientific Title Multi-centered Study for the Standardized Evaluation on Cleft Palate Speech
Date of disclosure of the study information 2018/11/20
Last modified on 2018/11/20

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Basic information
Public title Multi-centered Study for the Standardized Evaluation on Cleft Palate Speech
Acronym CAPS-A-JP
Scientific Title Multi-centered Study for the Standardized Evaluation on Cleft Palate Speech
Scientific Title:Acronym CAPS-A-JP
Region
Japan

Condition
Condition Cleft lip and/or palate
Classification by specialty
Oto-rhino-laryngology Oral surgery Plastic surgery
Rehabilitation medicine Dental medicine Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to establish the standardized evaluation of cleft palate speech which enhances inter-evaluator and inter-center comparison according to the international standards.
The standardized evaluation enables us to judge the efficacy of treatment or the severity of malfunction, which led to active exchange views in Japan and overseas.
Basic objectives2 Others
Basic objectives -Others Establishing the Japanese standardized evaluation of cleft palate speech
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes perceptual judgement
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 speech evaluatio
Interventions/Control_2 articulation
Interventions/Control_3 intervention
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
5 years-old <=
Age-upper limit
7 years-old >
Gender Male and Female
Key inclusion criteria cleft lip and/or palate
bilateral cleft lip and palate
unilateral cleft lip and palate
cleft palate
Key exclusion criteria mental retardation
hard hearing
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiji Nakamura
Organization Kyushu University
Division name Section of Oral and Maxillofacial Oncology Division of Maxillofacial Diagnostic and Surgical Sciences Faculty
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 092-642-6458
Email ogata.yuko.003@m.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Ogata
Organization Kyushu University
Division name Section of Oral and Maxillofacial Oncology Division of Maxillofacial Diagnostic and Surgical Science
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 092-642-6458
Homepage URL
Email ogata.yuko.003@m.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
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 九州大学(福岡県)、大阪保健医療大学(大阪府)、大阪大学(大阪府)、帝京平成大学(東京都)、北里大学(神奈川県)、愛知学院大学(愛知県)、昭和大学医学部(東京都)、昭和大学歯学部(東京都)、北海道医療大学(北海道)、鹿児島大学(鹿児島県)、NPO法人ことリ(福岡県)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 20 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
2018 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 20 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
2018 Year 11 Month 09 Day
Last modified on
2018 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039720

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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