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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034983
Receipt No. 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 2019/01/21

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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
Middle name
Last name Eiichi Saitoh
Organization Fujita Health University School of Medicine
Division name Department of Rehabilitation Medicine I
Zip code
Address 1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL 0562-93-2167
Email rehabmed@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yohei Otaka
Organization Fujita Health University School of Medicine
Division name Department of Rehabilitation Medicine I
Zip code
Address 1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL 0562-93-2167
Homepage URL
Email otaka119@mac.com

Sponsor
Institute Fujita Health University School of Medicine
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2019 Year 01 Month 21 Day
Last follow-up date
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
2019 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039893

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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