UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041055 |
|---|---|
| Receipt number | R000045706 |
| Scientific Title | Analysis of discourse characteristics of people with communication disorders |
| Date of disclosure of the study information | 2020/07/09 |
| Last modified on | 2020/07/09 23:07:25 |
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Basic information
Public title
Analysis of discourse characteristics of people with communication disorders
Acronym
Analysis of discourse characteristics of people with communication disorders
Scientific Title
Analysis of discourse characteristics of people with communication disorders
Scientific Title:Acronym
Analysis of discourse characteristics of people with communication disorders
Region
| Japan |
Condition
Condition
Aphasia, RHD with a communication disorders
Alzheimer's disease
Classification by specialty
| Neurology | Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the discourse characteristics of persons with communication disorders due to cerebrovascular diseases and dementia, which are the causes of typical communication disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the Japanese-Main Concept Analysis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
assessment of discourse and language
one intervention
Interventions/Control_2
assessment of discourse and language
one intervention
Interventions/Control_3
assessment of discourse and cognitive function
hearing test
one 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons who have been diagnosed with aphasic brain injury on the left side and has aphasia.
Persons who have been diagnosed as having the right side of the brain injury and a communication disorder.
Persons diagnosed with Alzheimer-type dementia.
Key exclusion criteria
Persons with hearing or visual impairments that interfere with inspection.
Persons with medical risks.
Persons who have difficulty understanding inspection instructions.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Yazu |
Organization
Nippon Medical School Hospital
Division name
Department of Oto-Rhino-Laryngology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
0358146371
h-yazu@nms.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Yazu |
Organization
Nippon Medical School Hospital
Division name
Department of Oto-Rhino-Laryngology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
0358146371
Homepage URL
h-yazu@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Association of Communication Disorders
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Bay Rehabilitation Hospital
Sagami Rehabilitation Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Hospital
Address
1-1-5, Sendagi, Bunkyo-Ku, Tokyo
Tel
0358146371
@nms.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
| 2020 | Year | 07 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 09 | Day |
Last modified on
| 2020 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045706
