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Knowledge Translation Intervention for ACL Injury Prevention Program in Youth Soccer

Primary Purpose

Anterior Cruciate Ligament Injuries, Lower Extremity Problem

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Knowledge Translation Intervention
Educational handout
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anterior Cruciate Ligament Injuries

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Michigan-FlintRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Knowledge Translation Intervention

Educational Handout

Arm Description

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 coaches will receive an educational handout describing an ACL-IPP.

Outcomes

Primary Outcome Measures

Uptake of ACL-IPP
Reported frequency of implementation of ACL-IPP
Number of ACL injuries

Secondary Outcome Measures

Change in 5-10-5 test time
Average change in 5-10-5 (Pro Agility) test time
Change in horizontal jump distance
Average change in forward jumping distance
Change in 10 meter forward run time
Average change in time spent running 10 meters
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

Full Information

First Posted
June 23, 2022
Last Updated
March 29, 2023
Sponsor
University of Michigan
Collaborators
Community Foundation of Greater Flint
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1. Study Identification

Unique Protocol Identification Number
NCT05442879
Brief Title
Knowledge Translation Intervention for ACL Injury Prevention Program in Youth Soccer
Official Title
The Effects of a Knowledge Translation Intervention With an ACL Prevention Program on Implementation, Injury Rates, and Performance in Youth Soccer Players
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Community Foundation of Greater Flint

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries, Lower Extremity Problem

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Knowledge Translation Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Educational Handout
Arm Type
Active Comparator
Arm Description
The coaches will receive an educational handout describing an ACL-IPP.
Intervention Type
Behavioral
Intervention Name(s)
Knowledge Translation Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Educational handout
Intervention Description
Educational handout describing a commonly cited ACL-IPP.
Primary Outcome Measure Information:
Title
Uptake of ACL-IPP
Description
Reported frequency of implementation of ACL-IPP
Time Frame
up to 2 years
Title
Number of ACL injuries
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Change in 5-10-5 test time
Description
Average change in 5-10-5 (Pro Agility) test time
Time Frame
2-4 months
Title
Change in horizontal jump distance
Description
Average change in forward jumping distance
Time Frame
2-4 months
Title
Change in 10 meter forward run time
Description
Average change in time spent running 10 meters
Time Frame
2-4 months
Title
Number of time-loss lower extremity injuries
Description
Number of reported injuries to the foot, ankle, knee, and hip which cause a player to miss time with team
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
William Suits, DPT
Phone
810-237-6671
Email
whsuits@umich.edu
Facility Information:
Facility Name
University of Michigan-Flint
City
Flint
State/Province
Michigan
ZIP/Postal Code
48502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Suits
Phone
810-237-6671
Email
whsuits@umich.edu
First Name & Middle Initial & Last Name & Degree
William Suits, DPT

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Knowledge Translation Intervention for ACL Injury Prevention Program in Youth Soccer

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