## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** HUM00214282
#### Organization
**Class:** OTHER
**Full Name:** University of Michigan
### Status Module
#### Completion Date
**Date:** 2024-08-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-15

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-08-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-07-01

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2022-07-05
**Type:** ACTUAL
**Study First Submit Date:** 2022-06-23
**Study First Submit QC Date:** 2022-06-28
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Community Foundation of Greater Flint

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Michigan

#### Responsible Party

**Investigator Affiliation:** University of Michigan

**Investigator Full Name:** William Suits

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Anterior Cruciate Ligament Injuries

- Lower Extremity Problem

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 671

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Behavioral: Knowledge Translation Intervention

**Label:** Knowledge Translation Intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Behavioral: Educational handout

**Label:** Educational Handout

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Knowledge Translation 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.

**Name:** Knowledge Translation Intervention

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Educational Handout

**Description:** Educational handout describing a commonly cited ACL-IPP.

**Name:** Educational handout

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Reported frequency of implementation of ACL-IPP

**Measure:** Uptake of ACL-IPP

**Time Frame:** up to 2 years

**Measure:** Number of ACL injuries

**Time Frame:** up to 2 years

#### Secondary Outcomes

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

**Measure:** Change in 5-10-5 test time

**Time Frame:** 2-4 months

**Description:** Average change in forward jumping distance

**Measure:** Change in horizontal jump distance

**Time Frame:** 2-4 months

**Description:** Average change in time spent running 10 meters

**Measure:** Change in 10 meter forward run time

**Time Frame:** 2-4 months

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

**Measure:** Number of time-loss lower extremity injuries

**Time Frame:** up to 2 years

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 19 Years

**Minimum Age:** 14 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Flint

**Country:** United States

**Facility:** University of Michigan-Flint

**State:** Michigan

**Zip:** 48502

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007718

- Term: Knee Injuries

- ID: D000007869

- Term: Leg Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M601

- Name: Anterior Cruciate Ligament Injuries

- Relevance: HIGH

- As Found: Anterior Cruciate Ligament Injuries

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Injury

- ID: M10738

- Name: Knee Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M10881

- Name: Leg Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000070598

- Term: Anterior Cruciate Ligament Injuries

### Misc Info Module

- Version Holder: 2024-05-24
