- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06255899
Injury Prevention for Female Lacrosse Athletes
Does Adding Individualized Feedback on Movement Improve Effectiveness of an Injury Prevention Program in Female Lacrosse Athletes?
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 92182
- San Diego State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Education
All participants will attend an educational training session on the team's Injury Prevention Program (IPP), which will be performed prior to practices and matches throughout the season.
All team members, coaching staff, and medical staff will attend the educational session.
This session will be administered during the pre-season training period, will last 60-90 minutes, and include a didactic component and a practical component in which all athletes on the team will receive instruction on how to properly perform each component of the IPP program.
and have an opportunity to practice performing the IPP on the field.
This is an evidence-based program that will be provided to all lacrosse athletes regardless of participation in the research study.
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The didactic component of the injury prevention education program includes information on prevalence of injuries in female athletes, biomechanical risk factors for injury, and effectiveness of injury prevention programs (IPP) for mitigation of injury risk.
Examples of different activities from the IPP, including proper and improper movement strategies will be provided.
Athletes will be instructed as a group on how to properly perform of each activity of the IPP, and will be given an opportunity to practice.
Athletes, coaches, and staff will be provided with links to written instructions and videos of proper performance for each activity.
The IPP will be performed at least 3 times/week prior to practice.
Coaches, staff, and athletes will be encouraged to provide supervision and feedback on performance of the IPP throughout the season.
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Experimental: Individualized Feedback + Education
After completing the Education Program, participants assigned to the individualized feedback group will perform the IPP during a strength and conditioning session while a research team member records their performance on a laboratory video camera.
The video will be analyzed to identify errors and compensations with movements and a plan for a feedback session to correct movements will be developed.
The feedback session will include showing the athlete their video, identifying the error or compensation, and providing verbal, tactile, and visual feedback to correct the error or compensation.
Two additional feedback sessions will be scheduled at regular intervals during the season.
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The didactic component of the injury prevention education program includes information on prevalence of injuries in female athletes, biomechanical risk factors for injury, and effectiveness of injury prevention programs (IPP) for mitigation of injury risk.
Examples of different activities from the IPP, including proper and improper movement strategies will be provided.
Athletes will be instructed as a group on how to properly perform of each activity of the IPP, and will be given an opportunity to practice.
Athletes, coaches, and staff will be provided with links to written instructions and videos of proper performance for each activity.
The IPP will be performed at least 3 times/week prior to practice.
Coaches, staff, and athletes will be encouraged to provide supervision and feedback on performance of the IPP throughout the season.
In addition to the education program, participants in this group will receive individualized feedback on performance of the IPP.
The participant will be videotaped while performing the IPP, and movement errors and compensations will be identified to provide a basis for feedback sessions to correct movement.
The session will include different forms of feedback including showing the athlete their video, identifying the error or compensation, and providing verbal, tactile, and visual feedback to correct the error or compensation.
Common errors and compensations, along with verbal cues and corrections, have been identified and manualized for the study.
Two additional feedback sessions will be scheduled at regular intervals during the season to provide feedback on performance throughout the season.
Participants in this group will be encouraged to provide peer feedback to one another.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Initial Contact Knee Valgus During Drop Vertical Jump
Time Frame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Knee Valgus Angle at Initial Contact
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Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Maximum Knee Valgus during Drop Vertical Jump
Time Frame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Maximum Knee Valgus Angle During Landing
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Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Initial Contact Knee Flexion during Drop Vertical Jump
Time Frame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Knee Flexion Angle at Initial Contact
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Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Maximum Knee Flexion during Drop Vertical Jump
Time Frame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Maximum Knee Flexion Angle During Landing
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Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Force Asymmetry during Drop Vertical Jump
Time Frame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Difference between left and right Maximum Vertical Ground Reaction Force During Landing
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Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Reach Distance During Anterior Direction of the Star Excursion Balance Test
Time Frame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Left and right maximum reach distances, normalized to leg length
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Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Reach Distance During Posterior-Medial Direction of the Star Excursion Balance Test
Time Frame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Left and right maximum reach distances, normalized to leg length
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Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Reach Distance During Posterior-Lateral Direction of the Star Excursion Balance Test
Time Frame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Left and right maximum reach distances, normalized to leg length
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Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Composite Reach Distance During the Star Excursion Balance Test
Time Frame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Average normalized maximum reach distances across the anterior, posterior-medial, and posterior-lateral directions (right and left calculated separately).
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Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Reach Distance Asymmetry During Anterior Direction of the Star Excursion Balance Test
Time Frame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Difference between left and right maximum reach distances (in centimeters)
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Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Reach Distance Asymmetry During Posterior-Medial Direction of the Star Excursion Balance Test
Time Frame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Difference between left and right maximum reach distances (in centimeters)
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Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Reach Distance Asymmetry During Posterior-Lateral Direction of the Star Excursion Balance Test
Time Frame: Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Difference between left and right maximum reach distances (in centimeters)
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Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Frequency of Injuries in Current Season
Time Frame: up to 16 weeks
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Number of lower extremity injuries documented in the athlete's Electronic Health Record during the Spring 2023 Season.
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up to 16 weeks
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Frequency of Injuries in Prior Season
Time Frame: up to 12 months
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Number of lower extremity injuries documented in the athlete's Electronic Health Record during the prior Spring 2022 season.
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up to 12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Participant Information
Time Frame: Baseline
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Participant date of birth, age, sex at birth, limb dominance, primary position, playing time, glasses/contacts, footwear, brace, orthotic or taping use, current medication, and injury history.
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Baseline
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Height
Time Frame: Baseline
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Measured height in inches
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Baseline
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Weight
Time Frame: Baseline
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Measured weight in pounds
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Baseline
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Leg Length
Time Frame: Baseline
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Measured right and left leg length in centimeters
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Baseline
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Weekly Athlete Adherence Questionnaire Adherence to Components
Time Frame: Weekly throughout the study (15-16 weeks)
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Self-reported adherence to the components of the injury prevention program.
"Did you do all of the activities?" (Yes/No)
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Weekly throughout the study (15-16 weeks)
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Weekly Athlete Adherence Questionnaire Adherence to Instructions
Time Frame: Weekly throughout the study (15-16 weeks)
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Self-reported adherence to the instructions for the injury prevention program.
"Were you able to complete the movements in the way that you were instructed to?" (Yes/No)
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Weekly throughout the study (15-16 weeks)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sara P Gombatto, PT, PhD, San Diego State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HS-2022-0259
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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