NCT06255899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

January 6, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2023

Completed
9 months until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

January 6, 2023

Last Update Submit

February 2, 2024

Conditions

Keywords

injury prevention programbiomechanicseducationfeedbackfemalelacrosseathletes

Outcome Measures

Primary Outcomes (12)

  • Initial Contact Knee Valgus During Drop Vertical Jump

    Knee Valgus Angle at Initial Contact

    Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)

  • Maximum Knee Valgus during Drop Vertical Jump

    Maximum Knee Valgus Angle During Landing

    Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)

  • Initial Contact Knee Flexion during Drop Vertical Jump

    Knee Flexion Angle at Initial Contact

    Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)

  • Maximum Knee Flexion during Drop Vertical Jump

    Maximum Knee Flexion Angle During Landing

    Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)

  • Force Asymmetry during Drop Vertical Jump

    Difference between left and right Maximum Vertical Ground Reaction Force During Landing

    Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)

  • Reach Distance During Anterior Direction of the Star Excursion Balance Test

    Left and right maximum reach distances, normalized to leg length

    Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)

  • Reach Distance During Posterior-Medial Direction of the Star Excursion Balance Test

    Left and right maximum reach distances, normalized to leg length

    Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)

  • Reach Distance During Posterior-Lateral Direction of the Star Excursion Balance Test

    Left and right maximum reach distances, normalized to leg length

    Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)

  • Composite Reach Distance During the Star Excursion Balance Test

    Average normalized maximum reach distances across the anterior, posterior-medial, and posterior-lateral directions (right and left calculated separately).

    Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)

  • Reach Distance Asymmetry During Anterior Direction of the Star Excursion Balance Test

    Difference between left and right maximum reach distances (in centimeters)

    Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)

  • Reach Distance Asymmetry During Posterior-Medial Direction of the Star Excursion Balance Test

    Difference between left and right maximum reach distances (in centimeters)

    Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)

  • Reach Distance Asymmetry During Posterior-Lateral Direction of the Star Excursion Balance Test

    Difference between left and right maximum reach distances (in centimeters)

    Change from Baseline to Post-Season Biomechanics Assessment (15-16 weeks later)

Secondary Outcomes (2)

  • Frequency of Injuries in Current Season

    up to 16 weeks

  • Frequency of Injuries in Prior Season

    up to 12 months

Other Outcomes (6)

  • Participant Information

    Baseline

  • Height

    Baseline

  • Weight

    Baseline

  • +3 more other outcomes

Study Arms (2)

Education

ACTIVE COMPARATOR

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.

Behavioral: Education Program on Injury Prevention

Individualized Feedback + Education

EXPERIMENTAL

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.

Behavioral: Education Program on Injury PreventionBehavioral: Individualized Feedback + Education Program on Injury Prevention

Interventions

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.

EducationIndividualized Feedback + Education

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.

Individualized Feedback + Education

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

Location

Study Officials

  • Sara P Gombatto, PT, PhD

    San Diego State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Participants, care providers, investigators and primary outcomes assessors will not be masked. Standardized procedures and scripts will be used to ensure consistency of conducting biomechanical assessments for primary outcomes in the absence of masking outcomes assessors.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 6, 2023

First Posted

February 13, 2024

Study Start

January 6, 2023

Primary Completion

May 8, 2023

Study Completion

May 8, 2023

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

This is a pilot study. We do not plan to make individual participant data available to other researchers.

Locations