Viewing Study NCT07486466


Ignite Creation Date: 2026-03-26 @ 3:15 PM
Ignite Modification Date: 2026-03-30 @ 9:05 PM
Study NCT ID: NCT07486466
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2026-03-20
First Post: 2026-03-05
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: ACL Mechanical Property Changes in Female Collegiate Basketball Players During a Competitive Season
Sponsor: Fu Jen Catholic University Hospital
Organization:

Study Overview

Official Title: Mechanical Properties and Performance of the Anterior Cruciate Ligament in Female Basketball Players Before and After the Season
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2026-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This prospective cohort study aims to investigate whether the mechanical properties of the anterior cruciate ligament (ACL) undergo measurable changes throughout a competitive basketball season in female collegiate athletes. Female athletes are at a significantly higher risk for non-contact ACL injuries compared to males. Beyond acute injuries, cumulative stress from high-intensity sports may lead to subclinical alterations in the ligament's biomechanical properties, potentially increasing injury risk.

Using non-invasive shear wave elastography (SWE) and countermovement jump (CMJ) tests, the study will monitor 60 elite players before and after the University Basketball League (UBL) season. The findings will help identify potential signs of cumulative loading and contribute to the development of early detection markers for injury risk in female athletes.
Detailed Description: \[Introduction and Rationale\] The anterior cruciate ligament (ACL) is a critical stabilizer of the knee joint, particularly during high-demand athletic activities involving pivoting, rapid deceleration, and landing. Female athletes exhibit a significantly higher incidence (2 to 9 times) of non-contact ACL injuries compared to their male counterparts. While acute trauma is a well-recognized mechanism, emerging evidence suggests that cumulative loading over a competitive season may lead to subclinical alterations in the ligament's mechanical properties. These changes, such as decreased stiffness, may predispose athletes to injury by compromising joint stability and neuromuscular control. However, objective in vivo data regarding the seasonal adaptation of the ACL in elite athletes remains sparse.

\[Study Design and Participants\] This prospective cohort study will recruit 60 elite female collegiate basketball players from Division I teams of the University Basketball Association (UBA). The research is designed to track longitudinal changes in ACL integrity and functional performance across a full competitive season.

\[Study Procedures\]

Participants will undergo standardized assessments at two distinct time points:

Pre-season Assessment (Baseline): Conducted in October, prior to the start of the competitive UBL season.

Post-season Assessment: Conducted in April, following the conclusion of the competitive basketball season.

During each session, two primary modalities will be employed:

1. Imaging-based Assessment (Shear Wave Elastography):

Shear Wave Elastography (SWE) will be utilized to non-invasively quantify the mechanical properties of the ACL. The assessment will focus on:

Shear Wave Speed (m/s) Shear Modulus (kPa) These metrics serve as direct indicators of tissue stiffness and structural integrity. Measurements will be taken with the knee in a consistent, standardized position to ensure reproducibility.
2. Functional Biomechanical Performance (Countermovement Jump):

Participants will perform Countermovement Jumps (CMJ) on KFORCE force plates to evaluate lower limb dynamic performance. This functional test provides insight into the athlete's neuromuscular status. Key variables collected will include:

Jump Height (cm) Reactive Strength Index (RSI): Calculated as the ratio of jump height to ground contact time.

Force Metrics: Including eccentric and concentric impulse to analyze force production and absorption strategies.

\[Research Goal\] By integrating imaging-based mechanical data with functional biomechanical outcomes, this study seeks to identify potential "fatigue" markers or adaptive responses in the ACL resulting from seasonal athletic demands. The findings aim to bridge the gap between clinical imaging and athletic performance, ultimately informing individualized injury prevention strategies and early detection protocols for female athletes at risk.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: