UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037393 |
|---|---|
| Receipt number | R000041480 |
| Scientific Title | Assessment and measurement of pain in elderly dementia patients by computer vision systems. |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2019/07/17 09:04:51 |
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Basic information
Public title
Assessment and measurement of pain in elderly dementia patients by computer vision systems.
Acronym
Assessment and measurement of pain in elderly dementia patients by computer vision systems.
Scientific Title
Assessment and measurement of pain in elderly dementia patients by computer vision systems.
Scientific Title:Acronym
Assessment and measurement of pain in elderly dementia patients by computer vision systems.
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Psychiatry | Anesthesiology | Neurosurgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the system for detecting the pain of elderly dementia patients by analyzing facial expressions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To detect the tendency of facial movements by monitoring facial expressions with pain.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subject over 65 year-old with dementia
2. Subject over 65 year-old without dementia
Key exclusion criteria
1.Subject who can not obtain consent from proxies
Subjects with serious complications
Subjects that the researcher judged inappropriate
2.Subject who can not get consent
Subjects with serious complications
Subjects that the researcher judged inappropriate
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kawano |
Organization
Kochi Medical School
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku-city, Kochi
TEL
088-880-2471
takashika@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Marie |
| Middle name | |
| Last name | Shigematsu Locatelli |
Organization
Kochi Medical School
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku-city, Kochi
TEL
088-880-2471
Homepage URL
jm-marieslocatelli@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
none
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
Kochi Medical School
Address
Kohasu, Oko-cho, Nankoku-city, Kochi
Tel
088-880-2180
rinri21@kochi-u.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
| 2022 | Year | 07 | Month | 01 | 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
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 07 | Month | 17 | Day |
Last modified on
| 2019 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041480
