UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026884 |
|---|---|
| Receipt number | R000030842 |
| Scientific Title | Validation of Objective evaluation on emotional reaction of Unresponsive Wakefulness Syndrome patients by image analysis of change of facial expression caused by sound |
| Date of disclosure of the study information | 2017/04/06 |
| Last modified on | 2018/04/09 08:27:16 |
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Basic information
Public title
Validation of Objective evaluation on emotional reaction of Unresponsive Wakefulness Syndrome patients by image analysis of change of facial expression caused by sound
Acronym
Facial Analysis of Unresponsive Wakefulness Syndrome patients
Scientific Title
Validation of Objective evaluation on emotional reaction of Unresponsive Wakefulness Syndrome patients by image analysis of change of facial expression caused by sound
Scientific Title:Acronym
Facial Analysis of Unresponsive Wakefulness Syndrome patients
Region
| Japan |
Condition
Condition
Unresponsive Wakefulness Syndrome Patients
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine emotional response of pleasant-unpleasant from facial expression change to speech transmission of Unresponsive Wakefulness Syndrome Patients
Basic objectives2
Others
Basic objectives -Others
This study investigats having reaction or not of Unresponsive Wakefulness Syndrome Patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Facial Analysis
Key secondary outcomes
Vital signs
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
hearing sound
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
| 13 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who were diagnosed with disorder of consciousness by a doctor. The patient whom a hearing function remains in.
Key exclusion criteria
Those who are closed for a long time,thosewho are wearing ventilators orally or nasally,those who have abnormality in hearing before the injury.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chiharu Akazawa |
Organization
Osaka medical College
Division name
Faculty of Nursing
Zip code
Address
7-6 hatchonishi-machi,takatsuki,Osaka
TEL
072-683-1221
m.higo@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masako Higo |
Organization
Osaka medical College
Division name
Faculty of Nursing
Zip code
Address
7-6 hatchonishi-machi,takatsuki,Osaka
TEL
072-683-1221
Homepage URL
m.higo@osaka-med.ac.jp
Sponsor or person
Institute
Osaka medical College Faculty of Nursing
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 04 | Month | 06 | 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 06 | Day |
Last modified on
| 2018 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030842
