UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052164 |
|---|---|
| Receipt number | R000059484 |
| Scientific Title | Examining factors which cause impaired verb production in agrammatism and its relationship to agrammatism. |
| Date of disclosure of the study information | 2023/09/20 |
| Last modified on | 2024/11/18 20:52:03 |
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Basic information
Public title
Examining factors which cause impaired verb production in agrammatism and its relationship to agrammatism.
Acronym
Examining factors which cause impaired verb production in agrammatism and its relationship to agrammatism.
Scientific Title
Examining factors which cause impaired verb production in agrammatism and its relationship to agrammatism.
Scientific Title:Acronym
Examining factors which cause impaired verb production in agrammatism and its relationship to agrammatism.
Region
| Japan |
Condition
Condition
aphasia caused by stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of syntactic and morphological features of verbs on verb production in aphasics. We will also examine the relationship between verb production and the presence of grammatical disorders.
Basic objectives2
Others
Basic objectives -Others
To reveal the mechanism of verb production disorder in aphasic patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
verb expression and accuracy of grammaticality judgment
Key secondary outcomes
Base
Study type
Observational
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
Aphasia group
1. Broca's area is damaged due to stroke
2. More than 1 month has passed since the stroke
3. AQ of 50-90 on the WAB aphasia test
4. Verbal Production is impaired in comparison to comprehension, and with grammatical impairment.
Non aphasia group
5. Patients without the left cerebral hemisphere damage due to cerebrovascular disease
6. Patients do not have aphasia.
Key exclusion criteria
1. Has a history of other strokes in the past
2. Clearly impaired intellectual function
3. Difficulty in recognizing pictures due to agnosia or poor vision
4. Difficulty in understanding auditory instruction due to severe hearing loss
5. Minors
6. Persons presenting depression, head injury, degenerative disease, or brain tumor
7. Persons who are deemed unsuitable by the doctor
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Takatsu |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Department of rehabilitation
Zip code
275-0026
Address
4-1-1, Yatsu, Narashino-city, Chiba
TEL
047-453-9000
lang-nobu@gmail.com
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Takatsu |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Department of rehabilitation
Zip code
275-0026
Address
4-1-1, Yatsu, Narashino-city, Chiba
TEL
047-453-9000
Homepage URL
lang-nobu@gmail.com
Sponsor or person
Institute
Tokyo Bay Rehabilitation Hospital
Institute
Department
Personal name
Nobuhiro Takatsu
Funding Source
Organization
Tokyo Bay Rehabilitation Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kanda University of International Studies
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Bay Rehabilitation Hospital
Address
4-1-1, Yatsu, Narashino-city, Chiba
Tel
047-453-9000
shinsakai@wanreha.net
Secondary IDs
Secondary IDs
YES
Study ID_1
299
Org. issuing International ID_1
Tokyo Bay Rehabilitation Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京湾岸リハビリテーション病院(千葉県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 03 | 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
none
Management information
Registered date
| 2023 | Year | 09 | Month | 10 | Day |
Last modified on
| 2024 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059484
