- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05442879
Knowledge Translation Intervention for ACL Injury Prevention Program in Youth Soccer
October 10, 2024 updated by: William Suits, University of Michigan
The Effects of a Knowledge Translation Intervention With an ACL Prevention Program on Implementation, Injury Rates, and Performance in Youth Soccer Players
Anterior cruciate ligament (ACL) injuries of the knee are common in youth soccer players, and show an even higher prevalence in female soccer players.
Clinical practice guidelines recommend ACL injury prevention programs (ACL-IPP) to reduce injury risk, yet implementation in amateur youth soccer is low, reducing actual real-world effectiveness.
This trial is a pragmatic effectiveness trial for ACL injury prevention for amateur youth soccer players, using a knowledge translation intervention with the Knowledge-to-Action Framework.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
ACL injury prevention programs (ACL-IPP) are exercise programs recommended by clinical practice guidelines that have been shown to reduce the risk of an ACL injury.
However, implementation of these programs is low, which reduces the real-world effectiveness of these programs.
This project will assess a knowledge translation intervention with youth soccer programs for implementation of ACL-IPPs utilizing the Knowledge-to-Action Framework.
The main educational intervention will be a knowledge translation (KT) intervention between the researchers, and coaches/players of youth soccer programs within the state of Michigan.
Specifics of the knowledge translation intervention will or may include focus groups, surveys, in-person training, video handouts, and paper handouts.
This will be compared to coaches/teams that are offered a handout that describes an evidence-based ACL-IPP.
Study Type
Interventional
Enrollment (Actual)
671
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Flint, Michigan, United States, 48502
- University of Michigan-Flint
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Amateur youth soccer organizations within southern Michigan.
Exclusion Criteria:
- Players above the age of 19 or below the age of 14
- Teams that have dedicated medical staffing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Experimental: Knowledge Translation Intervention
The group participating in the KT intervention program will participate in focus groups, individual meetings, and receive videos, informational handouts and on-field training from the researchers.
The researchers and participants will work together to determine barriers and facilitators towards implementation of an ACL-IPP, and create an ACL-IPP that follows established clinical practice guidelines and is individualized to the local contextual needs.
|
The KT intervention utilizes the communications between the teams and the researchers to promote implementation of the ACL-IPPs.
The meetings will provide opportunities for mutually beneficial learning from the researchers, and feedback from the coaches on how to best implement strategies through local barriers in order to facilitate necessary changes to promote ACL-IPP usage while adhering to clinical practice guideline recommendations.
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Active Comparator: Educational Handout
The coaches will receive an educational handout describing an ACL-IPP.
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Educational handout describing a commonly cited ACL-IPP.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Uptake of ACL-IPP
Time Frame: up to 2 years
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Reported frequency of implementation of ACL-IPP
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up to 2 years
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Number of ACL injuries
Time Frame: up to 2 years
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up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in 5-10-5 test time
Time Frame: 2-4 months
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Average change in 5-10-5 (Pro Agility) test time
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2-4 months
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Change in horizontal jump distance
Time Frame: 2-4 months
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Average change in forward jumping distance
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2-4 months
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Change in 10 meter forward run time
Time Frame: 2-4 months
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Average change in time spent running 10 meters
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2-4 months
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Number of time-loss lower extremity injuries
Time Frame: up to 2 years
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Number of reported injuries to the foot, ankle, knee, and hip which cause a player to miss time with team
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up to 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2022
Primary Completion (Actual)
April 30, 2024
Study Completion (Actual)
August 30, 2024
Study Registration Dates
First Submitted
June 23, 2022
First Submitted That Met QC Criteria
June 28, 2022
First Posted (Actual)
July 5, 2022
Study Record Updates
Last Update Posted (Actual)
October 15, 2024
Last Update Submitted That Met QC Criteria
October 10, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00214282
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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