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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05442879
Other study ID # HUM00214282
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date August 30, 2024

Study information

Verified date April 2024
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 671
Est. completion date August 30, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 19 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Knowledge Translation Intervention
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.
Educational handout
Educational handout describing a commonly cited ACL-IPP.

Locations

Country Name City State
United States University of Michigan-Flint Flint Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan Community Foundation of Greater Flint

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Uptake of ACL-IPP Reported frequency of implementation of ACL-IPP up to 2 years
Primary Number of ACL injuries up to 2 years
Secondary Change in 5-10-5 test time Average change in 5-10-5 (Pro Agility) test time 2-4 months
Secondary Change in horizontal jump distance Average change in forward jumping distance 2-4 months
Secondary Change in 10 meter forward run time Average change in time spent running 10 meters 2-4 months
Secondary Number of time-loss lower extremity injuries Number of reported injuries to the foot, ankle, knee, and hip which cause a player to miss time with team up to 2 years
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