Tokyo, Feb. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060585) titled 'An Investigation of Risk Factors for Concussion in Japanese American Football: Associations with Helmet Structure and Neck Muscle Strength' on Feb. 8.

Study Type: Observational

Primary Sponsor: Institute - St. Marianna University School of Medicine

Condition: Condition - Concussion Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to establish foundational knowledge for developing practical preventive measures to reduce the risk of head injuries and concussions among university American football players in Japan. Specifically, it will conduct the following investigations and analyses from two perspectives: protective gear (helmets) and physical factors (the neck region). 1. Through interviews, we will determine the actual usage patterns of helmets employed in Japanese university football. We will disassemble helmets to compare and examine their structural characteristics, clarifying their impact on preventing head injuries. 2. We will measure the circumference, muscle strength, and stiffness of players' necks. We will analyze the relationship between these measurements and helmet type, and further clarify the association with the risk of concussion occurrence. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male Key inclusion criteria - 1. University students (years 1 to 4) who belong to the Senshu University American football team and have provided written informed consent. 2. Healthy participants who can undergo neck circumference measurement, neck muscle strength testing, and neck muscle hardness assessment without injury and with normal performance of all measurements. Key exclusion criteria - 1. Participants will be excluded if written informed consent cannot be obtained. 2. Participants who become unable to continue measurements due to progression of any disease or medical condition. 3. Participants for whom the participating physicians determine that measurements should be discontinued. 4. Any other participants deemed inappropriate for the study by the participating physicians. Target Size - 150

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 30 Day Anticipated trial start date - 2026 Year 02 Month 09 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069301

Disclaimer: Curated by HT Syndication.