UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051340 |
|---|---|
| Receipt number | R000058569 |
| Scientific Title | Development of Japanese sign langugage aphasia test |
| Date of disclosure of the study information | 2023/06/14 |
| Last modified on | 2023/06/14 11:39:22 |
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Basic information
Public title
Development of Japanese sign langugage aphasia test
Acronym
Japanese sign langugage aphasia test
Scientific Title
Development of Japanese sign langugage aphasia test
Scientific Title:Acronym
Japanese sign langugage aphasia test
Region
| Japan |
Condition
Condition
sign langugage aphasia
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
When deaf people who use sign language develop aphasia, it has been shown that they are impaired in reading and understanding sign language and in expressing what they want to say in sign language, respectively, and this is called "aphasia of sign language. In the United States and the United Kingdom, tests to evaluate cognitive dysfunction in the deaf are being established, including "sign language aphasia". In Japan, these tests have not been sufficiently studied and evaluation methods have not been established.
The purpose of this study is to clarify the difficulties in using existing cognitive function tests for the deaf and to evaluate the usefulness of the originally developed sign language-based call test.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Study subjects will first be asked to fill out an information sheet to confirm that they do not meet the inclusion/exclusion criteria. The Mini-Mental State Examination (MMSE) and Raven's Colored Progressive Materices (RCPM) will be administered as existing cognitive function tests to confirm whether cognitive functions and basic language functions are maintained. We also evaluate whether there are any items that are difficult for the deaf person to respond to. Finally, a sign language call test is conducted to evaluate the response of the deaf person. The test time is limited to a maximum of one hour per person. The responses of the subjects during the test will be recorded by video camera and analyzed.
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Study subjects will first be asked to fill out an information sheet to confirm that they do not meet the inclusion/exclusion criteria. The Mini-Mental State Examination (MMSE) and Raven's Colored Progressive Materices (RCPM) will be administered as existing cognitive function tests to confirm whether cognitive functions and basic language functions are maintained. We also evaluate whether there are any items that are difficult for the deaf person to respond to. Finally, a sign language call test is conducted to evaluate the response of the deaf person. The test time is limited to a maximum of one hour per person. The responses of the subjects during the test will be recorded by video camera and analyzed.
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
| 15 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects must be congenitally deaf or have become deaf before school age and use sign language on a daily basis, and must be 15 years of age or older, in good health, and have no history of neurological disease (e.g., stroke or brain tumor).
Key exclusion criteria
Patients with a history of neurological disease or suspected cognitive decline will be excluded from the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sayuri |
| Middle name | |
| Last name | Ito |
Organization
Niigata University of Health and Welfare
Division name
Department of Speech, Language, and Hearing Sciences, Faculty of Rehabilitation
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
TEL
025-257-4507
sayuri-ito@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Sayuri |
| Middle name | |
| Last name | Ito |
Organization
Niigata University of Health and Welfare
Division name
Department of Speech, Language, and Hearing Sciences, Faculty of Rehabilitation
Zip code
950-3111
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
TEL
025-257-4507
Homepage URL
sayuri-ito@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Sayuri Ito
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
Tel
025-257-4507
sayuri-ito@nuhw.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
| 2023 | Year | 06 | Month | 14 | 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
| 2023 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2023 | Year | 06 | Month | 14 | Day |
Last modified on
| 2023 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058569
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