NCT05442879

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
671

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

1.8 years

First QC Date

June 23, 2022

Last Update Submit

October 10, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Uptake of ACL-IPP

    Reported frequency of implementation of ACL-IPP

    up to 2 years

  • Number of ACL injuries

    up to 2 years

Secondary Outcomes (4)

  • Change in 5-10-5 test time

    2-4 months

  • Change in horizontal jump distance

    2-4 months

  • Change in 10 meter forward run time

    2-4 months

  • Number of time-loss lower extremity injuries

    up to 2 years

Study Arms (2)

Knowledge Translation Intervention

EXPERIMENTAL

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

Educational Handout

ACTIVE COMPARATOR

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

Behavioral: Educational handout

Interventions

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.

Knowledge Translation Intervention

Educational handout describing a commonly cited ACL-IPP.

Educational Handout

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Amateur youth soccer organizations within southern Michigan.

You may not qualify if:

  • Players above the age of 19 or below the age of 14
  • Teams that have dedicated medical staffing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan-Flint

Flint, Michigan, 48502, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 23, 2022

First Posted

July 5, 2022

Study Start

July 1, 2022

Primary Completion

April 30, 2024

Study Completion

August 30, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Locations