UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056763 |
|---|---|
| Receipt number | R000063731 |
| Scientific Title | Effectiveness of dementia muffs in physically restrained patients. -Validation of facial emotion recognition AI and symptom change-. |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2026/01/21 21:01:58 |
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Basic information
Public title
Effectiveness of dementia muffs in physically restrained patients. -Validation of facial emotion recognition AI and symptom change-.
Acronym
Effectiveness of dementia muffs in physically restrained patients.
Scientific Title
Effectiveness of dementia muffs in physically restrained patients. -Validation of facial emotion recognition AI and symptom change-.
Scientific Title:Acronym
Effectiveness of dementia muffs in physically restrained patients. -Validation of facial emotion recognition AI and symptom change-.
Region
| Japan |
Condition
Condition
Patients requiring physical restraint
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the effectiveness of dementia muffs in reducing physical restraint time and stress with facial emotion recognition AI.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Five emotion averages for NUTRAL, SAD, SURPRISE, HAPPY and ANGRY using facial emotion recognition AI.
Key secondary outcomes
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
The filming starts (for approximately 1 minute) with the patient in physical restraints between 9:00 and 17:00 during the day shift. The restraints are removed and a muff is applied. After the muff is put on, the patient rests for about 2 minutes and is then filmed (for about 1 minute). The illuminance, humidity and temperature should also be measured at that time.
Always film with at least two people, one person filming the video and the other being the observer to maintain the patient's safety. Before and after the patient wears the dementia muff, a video of the patient's facial expressions is taken in about one minute, and the recorded video is analysed by MAL Face Emotion using AI analysis. The average value of facial emotions when using the dementia muff is evaluated.
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
1 This category includes those who are eligible for Dementia Care Team rounds and still require physical restraints.
2 There are no restrictions on gender, disease name, or treatment method.
Key exclusion criteria
(1) Patients who take measures against contact infection, droplet infection and airborne infection.
(2) Patients with severe facial injuries and inability to recognise facial expressions.
(3) Patients who have difficulty in obtaining consent.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kido |
Organization
Nara Medical University
Division name
Department of Rehabilitation Medicine
Zip code
634-8521
Address
840 Shijo-cho, Kashihara City, Nara Prefecture
TEL
0744-22-3051
akirakid@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Sasaki |
Organization
Nara Medical University
Division name
Department of Rehabilitation Medicine
Zip code
634-8521
Address
840 Shijo-cho, Kashihara City, Nara Prefecture
TEL
0744-22-3051
Homepage URL
rehaka@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
No
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
Nara Medical University
Address
840 Shijo-cho, Kashihara City, Nara Prefecture
Tel
0744-22-3051
rehaka@naramed-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
| 2025 | Year | 02 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 20 | Day |
Last modified on
| 2026 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063731
