Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06255899
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2023-01-06
Brief Title:
Injury Prevention for Female Lacrosse Athletes
Sponsor:
San Diego State University
Organization:
San Diego State University
Study Overview
Official Title:
Does Adding Individualized Feedback on Movement Improve Effectiveness of an Injury Prevention Program in Female Lacrosse Athletes
Status:
COMPLETED
Status Verified Date:
2024-02
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:
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 womens 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 womens lacrosse athletes from the San Diego State University womens 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 Womens 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 womens 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 womens 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 N20 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 athletes 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 Fishers 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 Cohens 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
The investigators will recruit a purposive sample of 20 women from the SDSU Womens 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 womens 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 womens 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 N20 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 athletes 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 Fishers 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 Cohens 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 Oversight
Has Oversight DMC:
None
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?:
None