Tokyo, June 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061814) titled 'Development and Validation of a Skeletal Muscle Mass Estimation Model Using Smartphone-Captured Lower-Leg Images' on June 5.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Kurume University

Condition: Condition - Healthy adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to validate a deep learning-based method for estimating skeletal muscle index (SMI) using lateral and posterior lower-leg images captured with smartphones and digital cameras. In addition, differences in predictive performance according to imaging device and imaging direction will be investigated, and comparison with calf circumference, a conventional surrogate measure of skeletal muscle mass, will be performed to evaluate the usefulness of image-based assessment. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Lateral and posterior lower-leg images will be captured once using a smartphone and a digital camera. On the same day, skeletal muscle mass will be measured once using bioelectrical impedance analysis (InBody 470), and calf circumference will be measured once.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Individuals who provide written informed consent to participate in the study 2. Healthy adults aged 18 years or older 3. Individuals capable of maintaining standing and sitting positions during assessment 4. Individuals able to undergo lower-leg image acquisition and bioelectrical impedance analysis Key exclusion criteria - 1. Individuals who have difficulty maintaining a standing position 2. Individuals with edema or other conditions affecting the lower leg 3. Individuals with implanted medical devices such as cardiac pacemakers 4. Individuals with any limb amputation 5. Individuals with metallic implants or fixation devices in the body 6. Individuals who are pregnant or may be pregnant 7. Individuals with a history of fractures or ligament injuries of the lower limbs 8. Individuals with a history of central or peripheral nervous system disorders 9. Individuals deemed unsuitable for participation in the study by the principal investigator or co-investigators Target Size - 100

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2025 Year 01 Month 30 Day Date of IRB - 2025 Year 01 Month 30 Day Anticipated trial start date - 2025 Year 02 Month 14 Day Last follow-up date - 2025 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070735

Disclaimer: Curated by HT Syndication.