UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055478 |
|---|---|
| Receipt number | R000063390 |
| Scientific Title | The Effectiveness of Drawing Training in People with Aphasia. |
| Date of disclosure of the study information | 2024/09/15 |
| Last modified on | 2025/09/16 22:29:09 |
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Basic information
Public title
The Effectiveness of Drawing Training in People with Aphasia.
Acronym
The Effectiveness of Drawing Training in People with Aphasia.
Scientific Title
The Effectiveness of Drawing Training in People with Aphasia.
Scientific Title:Acronym
The Effectiveness of Drawing Training in People with Aphasia.
Region
| Japan |
Condition
Condition
Aphasia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Can drawing training focused on essential elements improve the communicative effectiveness of pictures drawn by people with aphasia?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The identification rate of the pictures.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
We will conduct drawing training focused on incorporating essential elements.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Has aphasia.
2. No intellectual impairment.
3. No severe constructional apraxia
4. Capable of providing written informed consent for voluntary participation in the study
5. Capable of self training.
Key exclusion criteria
1. Individuals who have difficulty understanding task instructions.
2. Patients with groval aphasia.
3. Patients with visual agnosia.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Noriyo |
| Middle name | |
| Last name | Komori |
Organization
International University of Health and Welfare
Division name
Department of Speech and Hearing Sciences
Zip code
324-8501
Address
2600-1, Kitakanemaru, otawara, Tochigi, JAPAN
TEL
0287243000
komori@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Noriyo |
| Middle name | |
| Last name | Komori |
Organization
International University of Health and Werfare
Division name
Department of Speech and Hearing Sciences
Zip code
324-8501
Address
2600-1, Kitakanemaru, Otawara, Tochigi, JAPAN
TEL
0287243000
Homepage URL
komori@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Noriyo Komori
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Administration Office
Address
1-24-1, Minamiaoyama, Minatoku, Tokyo, JAPAN
Tel
03-6388-5096
kenkyo@iuhw.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
| 2024 | Year | 09 | Month | 15 | 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
| 2024 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 09 | Month | 11 | Day |
Last modified on
| 2025 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063390
