UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034841 |
|---|---|
| Receipt number | 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 | 2023/11/12 10:39:22 |
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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
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
ogata.yuko.003@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 09 | Day |
Last modified on
| 2023 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039720
