UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062069 |
|---|---|
| Receipt number | R000071023 |
| Scientific Title | Preclinical feasibility study of an inertial measurement unit-based system for detecting ICU-relevant risky movements |
| Date of disclosure of the study information | 2026/06/26 |
| Last modified on | 2026/06/26 15:42:43 |
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Basic information
Public title
A preclinical study of a sensor-based system for detecting ICU-related risky movements
Acronym
ICU Risk Movement Sensor Study
Scientific Title
Preclinical feasibility study of an inertial measurement unit-based system for detecting ICU-relevant risky movements
Scientific Title:Acronym
SMILE-3 Study
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate, in healthy adults, the event-level detection performance, false alarm burden, attachment stability, and implementation feasibility of an IMU-based continuous movement monitoring system intended to support patient safety in the ICU, after improving the sensor configuration and fixation method, under conditions that include long-duration measurement, non-target movements, and clinical noise in a simulated ICU environment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Event-level F1 score for detecting target risky movements
Key secondary outcomes
Event-level sensitivity, specificity, precision, and accuracy
False alarm rate (false alarms per hour)
Time to detection (time from the onset of a target movement to detection)
Window-level accuracy, macro-F1, and class-wise F1
False detection rate for non-target movements
Performance comparison by sensor and sensor configuration
Sensor detachment rate, signal loss rate, number of communication interruptions, and number of reattachments
Skin symptoms at the attachment sites, pain, and discomfort assessed using a visual analog scale (VAS)
Measurement completion rate and participant-reported acceptability of sensor attachment
Feasibility of the sensor attachment and measurement procedures as assessed by research staff
Other related 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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults who have provided written informed consent to participate in the study
Individuals who can safely perform simulated movements on a bed
Key exclusion criteria
Individuals younger than 18 years or older than 65 years
Individuals who have difficulty performing the required movements due to musculoskeletal disorders, collagen diseases, or other conditions
Individuals with implanted electronic medical devices, such as pacemakers
Individuals with skin disease, wounds, or adhesive tape allergy at the sensor attachment sites
Individuals who are pregnant or may be pregnant and have difficulty remaining in a supine position for an extended period
Individuals who are judged by the principal investigator to be inappropriate for participation in this study for any other reason
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ryuto |
| Middle name | |
| Last name | Yokoyama |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Emergency Medicine
Zip code
990-9585
Address
2-2-2 Iida Nishi, Yamagata City, Yamagata Prefecture
TEL
0236331122
ryusi0311@gmail.com
Public contact
Name of contact person
| 1st name | RYUTO |
| Middle name | |
| Last name | YOKOYAMA |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Emergency Medicine
Zip code
9909585
Address
2-2-2 Iida Nishi, Yamagata City, Yamagata Prefecture
TEL
0236285422
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
0236331122
ryusi0311@gmail.com
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
| 2026 | Year | 06 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This preclinical feasibility study will evaluate an IMU-based continuous movement monitoring system in healthy adults before future clinical studies in ICU patients. After written informed consent, baseline information will be collected, and research-use IMU sensors will be attached to predefined sites on the limbs and trunk. Each participant will undergo approximately 60 minutes of continuous measurement in a simulated ICU environment, including target risky movements, non-target movements, resting states, and routine bed-based movements. Target movements include simulated tube self-removal, limb movement beyond the bed rail, sitting up, and pre-bed-exit movements. Non-target movements include turning over, repositioning, cough-like movements, scratching, hand-to-mouth movements not intended for device removal, rehabilitation-like movements, simulated nursing care, and conversation- or eating-like movements. All movements will be performed under staff supervision, with safety measures to prevent falls or injuries. The measurement will be stopped immediately if fatigue, pain, discomfort, skin symptoms, or any other abnormality occurs. Video recording will be performed only for movement labeling and verification of IMU time-series data. Video and sensor data will be managed using study IDs and securely stored according to the study protocol. The IMU sensors are research-use measurement devices and will not be used for diagnosis, treatment, or prevention.
Management information
Registered date
| 2026 | Year | 06 | Month | 26 | Day |
Last modified on
| 2026 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071023
