UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032890 |
|---|---|
| Receipt number | R000037491 |
| Scientific Title | Establishing and developing support system for affection and emotions of severe stutterers |
| Date of disclosure of the study information | 2018/06/06 |
| Last modified on | 2021/12/14 14:46:42 |
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Basic information
Public title
Establishing and developing support system for affection and emotions of severe stutterers
Acronym
Establishing and developing support system for affection and emotions of severe stutterers
Scientific Title
Establishing and developing support system for affection and emotions of severe stutterers
Scientific Title:Acronym
Establishing and developing support system for affection and emotions of severe stutterers
Region
| Japan |
Condition
Condition
Stuttering
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To scientifically examine the efficacy of RASS for stuttering in order to provide an optimal support method for individuals with severe stuttering
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stuttering symptoms
Fear, Anxiety, and Behavior Scale
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
RASS efficacy on individuals who stutter
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals with severe stuttering who provide written informed consent
Key exclusion criteria
Individuals who stutter that felt that doctors should perform treatment primarily in psychiatry departments
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Shiomi |
Organization
Kawasaki Medical School Hospital
Division name
Rehabilitation Center
Zip code
701-0192
Address
577,Matsushima,Kurashiki,Okayama
TEL
0864621111
shiomi@mw.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Shiomi |
Organization
Kawasaki Medical School Hospital
Division name
Rehabilitation Center
Zip code
701-0192
Address
577,Matsushima,Kurashiki,Okayama
TEL
0864621111
Homepage URL
shiomi@mw.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki University of Medical Walfare
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
Kawasaki University of Medical Walfare
Address
288,Matsushima,Kurashiki,Okayama
Tel
086-462-1111
shiomi@mw.kawasaki-m.ac.jp
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
| 2018 | Year | 06 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | 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 | 06 | Month | 06 | Day |
Last modified on
| 2021 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037491
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
