UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057800 |
|---|---|
| Receipt number | R000066058 |
| Scientific Title | Research aimed at improving the quality of safety management for critically ill patients through the use of inertial measurement unit sensors in collaboration with medical and engineering experts |
| Date of disclosure of the study information | 2025/05/20 |
| Last modified on | 2025/12/18 08:02:42 |
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Basic information
Public title
Development of monitoring technology using inertial measurement units and evaluation of its effectiveness in improving safety management for critically ill patients
Acronym
Inertial Measurement Unit-based Surveillance for Advanced Frailty Evaluation
Scientific Title
Research aimed at improving the quality of safety management for critically ill patients through the use of inertial measurement unit sensors in collaboration with medical and engineering experts
Scientific Title:Acronym
Improving the quality of safety management for critically ill patients through the use of inertial measurement unit sensors
Region
| Japan |
Condition
Condition
Delirium
Classification by specialty
| Anesthesiology | Emergency medicine | Intensive care medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To improve the quality of safety management for critically ill patients, inertial measurement unit (IMU) sensors will be attached to healthy persons to evaluate the accuracy of detecting and identifying agitated movements.
Basic objectives2
Others
Basic objectives -Others
Analyze data obtained from the IMU sensor and create a machine learning model to detect abnormal behavior.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Position of target area obtained from IMU sensor data
Key secondary outcomes
Air pressure
Average angular velocity
Peak angular velocity
Standard deviation of angular velocity
Maximum acceleration
Acceleration rate
Average angle
Angle rate
Standard deviation of angle
Variation in motion perception
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants will be asked to wear IMU sensors on their limbs and waist and perform several physical movements that we consider to be restless (elbow flexion/extension, standing, sitting, etc.). We assume that each movement will take several seconds to tens of seconds. It will take about 5 to 10 minutes to perform all of the planned physical movements. We expect that it will take about 15 to 20 minutes to attach and remove the IMU sensors.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy person
Key exclusion criteria
Individuals under the age of 18
Individuals with a history of musculoskeletal disorders or collagen diseases
Individuals with a pacemaker
Individuals who did not consent to participate in the study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | RYUTO |
| Middle name | |
| Last name | YOKOYAMA |
Organization
Yamagata University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
9902321
Address
2-2-2 Iida Nishi, Yamagata City, Yamagata Prefecture
TEL
08055544587
ryusi0311@gmail.com
Public contact
Name of contact person
| 1st name | RYUTO |
| Middle name | |
| Last name | YOKOYAMA |
Organization
Yamagata University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
9902321
Address
2-2-2 Iida Nishi, Yamagata City, Yamagata Prefecture
TEL
08055544587
Homepage URL
ryusi0311@gmail.com
Sponsor or person
Institute
Yamagata Univercity
Institute
Department
Personal name
RYUTO YOKOYAMA
Funding Source
Organization
Yamagata Univercity
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
Ethics Review Committee, Faculty of Medicine, Yamagata University
Address
2-2-2 Iida Nishi, Yamagata City, Yamagata Prefecture
Tel
023-633-1122
yu-ikekenkyu@jm.kj.yamagata-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 | 05 | Month | 20 | 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
15
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 | 04 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 09 | Month | 23 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 14 | Day |
Other
Other related information
Register 15 healthy individuals who meet the eligibility criteria between the date of approval for the study and January 1, 2027.
Management information
Registered date
| 2025 | Year | 05 | Month | 08 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066058
