UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046766 |
|---|---|
| Receipt number | R000053351 |
| Scientific Title | Reliability and validity of a Japanese version of the Stroke Stigma Scale |
| Date of disclosure of the study information | 2022/01/28 |
| Last modified on | 2024/03/27 09:44:53 |
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Basic information
Public title
Reliability and validity of a Japanese version of the Stroke Stigma Scale
Acronym
Reliability and validity of a Japanese version of the Stroke Stigma Scale
Scientific Title
Reliability and validity of a Japanese version of the Stroke Stigma Scale
Scientific Title:Acronym
Reliability and validity of a Japanese version of the Stroke Stigma Scale
Region
| Japan |
Condition
Condition
community-dwelling people with stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the reliability and validity of the Japanese version of the Stroke Stigma Scale.
Basic objectives2
Others
Basic objectives -Others
Reliability, Validity
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The Stroke Stigma Scale
Key secondary outcomes
The Center for Epidemiologic Studies Depression Scale (CES-D), Stroke Impact Scale
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a. Have had a stroke.
b. Lives in the community.
c. Able to understand the text when responding to the questionnaire.
d. Consented to participate in the study.
Key exclusion criteria
Responding to the scale is burdensome.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Kitamura |
Organization
Fujita Health University
Division name
Faculty of Rehabilitation, School of Health Sciences
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan
TEL
0562-93-9000
shin.kitamura@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Kitamura |
Organization
Fujita Health University
Division name
Faculty of Rehabilitation, School of Health Sciences
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan
TEL
0562-93-9000
Homepage URL
shin.kitamura@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Metropolitan University
Tokyo Bay Rehabilitation Hospital
Kunitachi Aoyagien
Lifesupport Hinata
Tomita Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
藤田医科大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 28 | 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
| 2021 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A questionnaire survey will be conducted on community-dwelling individuals after a stroke. The questionnaires will be a demographics questionnaire, the Japanese version of The Stroke Stigma Scale, CES-D, and Stroke Impact Scale. Based on the results, we will examine the test-retest reliability, structural validity, construct validity, criterion validity, and internal consistency.
Management information
Registered date
| 2022 | Year | 01 | Month | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053351
