Tokyo, June 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062069) titled 'A preclinical study of a sensor-based system for detecting ICU-related risky movements' on June 26.

Study Type: Observational

Primary Sponsor: Institute - Yamagata Univercity

Condition: Condition - None Classification by malignancy - Others Genomic information - NO

Objective: 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

Eligibility: Age-lower limit - 18 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 Size - 40

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071023

Disclaimer: Curated by HT Syndication.