UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034983 |
|---|---|
| Receipt number | R000039893 |
| Scientific Title | Establishment of a quantitative evaluation of human facial expressions. |
| Date of disclosure of the study information | 2018/11/23 |
| Last modified on | 2020/11/25 19:37:43 |
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Basic information
Public title
Establishment of a quantitative evaluation of human facial expressions.
Acronym
Quantitative evaluation of facial expressions.
Scientific Title
Establishment of a quantitative evaluation of human facial expressions.
Scientific Title:Acronym
Quantitative evaluation of facial expressions.
Region
| Japan |
Condition
Condition
Healthy adults and patients with central nervous system disorders, brain injury, or dementia.
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a quantitative facial expression evaluation using facial image analysis
Basic objectives2
Others
Basic objectives -Others
Facial analysis
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The magnitude of facial expressions evaluated by facial image analysis.
Key secondary outcomes
Questionnaires for subjective feelings
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Recording the facial expression during communication under various conditions, rehabilitative training, or performing various tasks (cognitive tasks, watching movies, or listening to music etc).
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
Patients
A person with disabilities in the activity of daily living caused by central nervous system disorders, brain injury, or dementia
Consent to participate in the study
Healthy adults
No past history of brain diseases, neurological/muscular diseases, or psychiatric disorders
Consent to participate in the study
Key exclusion criteria
Patients
Unstable medical conditions
Healthy adults
Past history of brain diseases, neurological/muscular diseases, or psychiatric disorders
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University School of Medicine
Division name
Department of Rehabilitation Medicine I
Zip code
4701192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2167
otaka119@mac.com
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University School of Medicine
Division name
Department of Rehabilitation Medicine I
Zip code
4701192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2167
Homepage URL
otaka119@mac.com
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University Ethics Review Committee
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） Fujita Health University
藤田医科大学病院（愛知県）Fujita Health University Hospital
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 23 | 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
| 2018 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 09 | 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
| 2018 | Year | 11 | Month | 23 | Day |
Last modified on
| 2020 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039893
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
