Knowledge Translation Intervention for ACL Injury Prevention Program in Youth Soccer

• Sponsor: University of Michigan (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05442879
• Collaborator: Community Foundation of Greater Flint (Other)
• Enrollment: 700
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6
• Patients Per Site Per Month: 117.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anterior Cruciate Ligament Injuries; Lower Extremity Problem	Behavioral: Knowledge Translation Intervention; Behavioral: Educational handout	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 700 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Effects of a Knowledge Translation Intervention With an ACL Prevention Program on Implementation, Injury Rates, and Performance in Youth Soccer Players
• Actual Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

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.	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.
Active Comparator: Educational Handout The coaches will receive an educational handout describing an ACL-IPP.	Behavioral: Educational handout; Educational handout describing a commonly cited ACL-IPP.

Outcome Measures

Primary Outcome Measures

1. Uptake of ACL-IPP [up to 2 years]

   Reported frequency of implementation of ACL-IPP

2. Number of ACL injuries [up to 2 years]

Secondary Outcome Measures

1. Change in 5-10-5 test time [2-4 months]

   Average change in 5-10-5 (Pro Agility) test time

2. Change in horizontal jump distance [2-4 months]

   Average change in forward jumping distance

3. Change in 10 meter forward run time [2-4 months]

   Average change in time spent running 10 meters

4. Number of time-loss lower extremity injuries [up to 2 years]

   Number of reported injuries to the foot, ankle, knee, and hip which cause a player to miss time with team

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 19 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan-Flint	Flint	Michigan	United States	48502

Sponsors and Collaborators

• University of Michigan
• Community Foundation of Greater Flint

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: William Suits, Assistant Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT05442879
• Other Study ID Numbers: HUM00214282
• First Posted: Jul 5, 2022
• Last Update Posted: Jul 15, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Wounds and Injuries; Anterior Cruciate Ligament Injuries

Study Results

No Results Posted as of Jul 15, 2022