Clinical trial NCT06255899: Injury Prevention for Female Lacrosse Athletes
Official title: Does Adding Individualized Feedback on Movement Improve Effectiveness of an Injury Prevention Program in Female Lacrosse Athletes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Extremity Problem
Keywords: injury prevention program
biomechanics
education
feedback
female
lacrosse
athletes
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The pilot study model is a single site, 2-arm parallel quasi-experimental intervention study. After completing the baseline testing, enrolled participants will be purposively assigned (non-random) to one of two intervention groups, control (education only) or education with individualized feedback, which will be balanced based on position, playing time, and history of injury.
Primary purpose: PREVENTION

Brief summary: In this pilot study the investigators are testing whether an injury prevention program will help improve quality of movement and decrease number of injuries in collegiate women's lacrosse athletes. The primary purpose is to determine whether an injury prevention program including individualized movement instruction along with an educational program is better than an educational program alone for improving movements that can increase risk of injury and decreasing number of injuries. The investigators will recruit women's lacrosse athletes from the San Diego State University women's lacrosse team. Enrolled participants will be divided up into two groups of 10 individuals. Both groups will participate in an injury prevention educational program including a lecture component with pictures and videos, and a practice component in which athletes will be provided with group instruction on how to perform the activities and then will have an opportunity to practice all activities. In addition to the educational program, athletes in the individualized movement instruction group will be provided individualized feedback on their movements when performing activities from the injury prevention program during 3 sessions throughout the season. The primary outcomes that will be evaluated include lower body movement during a jumping and balance task as measured using a 3D motion capture system. The investigators hypothesize that participants who receive the individualized feedback in addition to the education program will display greater improvements in movements that increase injury risk when compare to the education only intervention group.

Detailed description: The purpose of this pilot study is to determine whether augmenting an injury prevention program (IPP) with individualized video, verbal, and tactile feedback is more effective than implementation of an IPP with general education alone in female collegiate lacrosse players.

The investigators will recruit a purposive sample of 20 women from the SDSU Women's NCAA Division I Lacrosse team to conduct a quasi-experimental pilot study. To ensure adequate exposure to injury risk during matches, players who regularly participate in matches will be identified by athletics staff and offered the opportunity to participate in the study. Athletes who participate will be assigned (non-random) to one of two groups, control (education only) or education with individualized feedback, which will be balanced based on position, playing time, and history of injury.

All athletes and medical staff for the women's lacrosse team will attend a pre-season educational program focused on the purpose and benefits of IPPs, the importance of adherence to the IPP, and proper form when performing movements in the IPP to maximize injury prevention benefits. The program includes demonstration and practice of proper form, identification and correction of common errors and compensations. Videos and written documentation of the program will be shared with athletes, coaches and medical staff for reference. The athletes and staff will be encouraged to provide feedback to one another, to detect and correct errors and compensations, and help each other perform the program most optimally. This education program is scheduled to be implemented with all women's lacrosse athletes, regardless of whether the athletes participate in this research, as a joint effort between the principal investigator of the study and athletics staff, to address injury prevention for these athletes. The 10 participants assigned to the education with individualized feedback group will receive 3 additional sessions in which they receive individualized feedback on their movement when performing the IPP with one of 6 DPT students (supervised by PI Gombatto, licensed Physical Therapist). Individual feedback sessions will be 45-60 minutes and consist of a video review of athlete performance of the IPP, real-time feedback using a mirror, a combination of verbal and tactile feedback, and integration of peer feedback with a partner who is also receiving individualized feedback.

All participants (N=20) will complete pre-intervention (pre-season) and post-intervention (post-season) testing including a 3D biomechanics analysis, anthropometric and body composition measures, and questionnaires to identify other known risk factors for injury. The 3D biomechanical analysis will include an evaluation of lower extremity movement and forces with the Drop Vertical Jump (DVJ) and three directions of the Star Excursion Balance Test (SEBT). Injury history and incidence of injuries during the 2022 and 2023 season will be gathered from the athlete's electronic health records and via athlete self-report. Participant questionnaires will include questions about position, footwear, orthotic use, and taping. Adherence surveys will be administered weekly (15-16 weeks) via personalized text links or phone call (for non-responders) to record how often athletes are engaging in the IPP, self-correction, and peer feedback.

The primary outcomes of this study will be biomechanical risk factors associated with knee injury, including dynamic knee valgus during the DVJ and asymmetry in lower extremity reach distance during the SEBT. Secondary outcomes will include lower extremity injuries during the Spring 2023 season, examined between treatment groups, and for all participants between the Spring 2022 and Spring 2023 seasons. The primary outcome was selected because the intervention is proposed to change movements that place athletes at risk for injury, and injury is the secondary outcome because reduced injuries are the intended effect of the IPP but the sample size may not be sufficient to measure change in injuries during a single season with this pilot study.

Summary statistics for all outcomes will be examined for each treatment group. Analysis of variance (ANOVA) will be conducted to determine whether change in biomechanical risk factors is different between athletes in the education vs. education with individualized feedback groups (group x time interaction effect). Fisher's exact test will be used to test for differences in incidence of injury between groups. Number of lower extremity injuries across all participants will be quantitatively compared for the 2022 vs. 2023 season. Effect sizes (Cohen's d) will be calculated for each outcome. A power analysis will be performed to determine the number of subjects needed to detect significant effects in a larger sample.

Eligibility criteria: Inclusion Criteria:

* Athletes currently a member of the SDSU Women's NCAA Division I Lacrosse team.
* Athletes who regularly participate in games as identified by athletics staff.

Exclusion Criteria:

* Athletes deemed ineligible to participate in their sport by the team's medical staff because of an injury.
* Athletes who do not regularly participate in games throughout the season.

Primary outcomes:
measure: Initial Contact Knee Valgus During Drop Vertical Jump
timeFrame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
measure: Maximum Knee Valgus during Drop Vertical Jump
timeFrame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
measure: Initial Contact Knee Flexion during Drop Vertical Jump
timeFrame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
measure: Maximum Knee Flexion during Drop Vertical Jump
timeFrame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
measure: Force Asymmetry during Drop Vertical Jump
timeFrame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
measure: Reach Distance During Anterior Direction of the Star Excursion Balance Test
timeFrame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
measure: Reach Distance During Posterior-Medial Direction of the Star Excursion Balance Test
timeFrame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
measure: Reach Distance During Posterior-Lateral Direction of the Star Excursion Balance Test
timeFrame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
measure: Composite Reach Distance During the Star Excursion Balance Test
timeFrame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
measure: Reach Distance Asymmetry During Anterior Direction of the Star Excursion Balance Test
timeFrame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
measure: Reach Distance Asymmetry During Posterior-Medial Direction of the Star Excursion Balance Test
timeFrame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
measure: Reach Distance Asymmetry During Posterior-Lateral Direction of the Star Excursion Balance Test
timeFrame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
Secondary outcomes:
measure: Frequency of Injuries in Current Season
timeFrame: up to 16 weeks
measure: Frequency of Injuries in Prior Season
timeFrame: up to 12 months
Other outcomes:
measure: Participant Information
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Leg Length
timeFrame: Baseline
measure: Weekly Athlete Adherence Questionnaire Adherence to Components
timeFrame: Weekly throughout the study (15-16 weeks)
measure: Weekly Athlete Adherence Questionnaire Adherence to Instructions
timeFrame: Weekly throughout the study (15-16 weeks)
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
affiliation: San Diego State University
name: Sara P Gombatto, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: