UMIN-CTR Clinical Trial

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
Email	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
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	Fujita Health University Ethics Review Committee
Address	1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel	0562-93-2865
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039893