Anterior Cruciate Ligament InjuriesNCT05442879
Knowledge Translation Intervention for ACL Injury Prevention Program in Youth Soccer
A study testing Knowledge Translation Intervention and Educational handout in people with Anterior Cruciate Ligament Injuries and Lower Extremity Problem, run by University of Michigan at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Lower Extremity Problem
- What is being tested?
- Knowledge Translation Intervention and Educational handout
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 671 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Amateur youth soccer organizations within southern Michigan.
Who cannot join
- Players above the age of 19 or below the age of 14
- Teams that have dedicated medical staffing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Knowledge Translation Intervention With an ACL Prevention Program on Implementation, Injury Rates, and Performance in Youth Soccer Players
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.
Read the 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.
- Being tested
- Knowledge Translation Intervention, Educational handout
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knowledge Translation InterventionBehavioural
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 handoutBehavioural
Educational handout describing a commonly cited ACL-IPP.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Knowledge Translation Intervention |
| Educational Handout | Active comparator | The coaches will receive an educational handout describing an ACL-IPP. Receives: Behavioral: Educational handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of ACL-IPP
Reported frequency of implementation of ACL-IPP
Measured: up to 2 years
Number of ACL injuries
Measured: up to 2 years
Secondary outcomes (4)
Change in 5-10-5 test time
Average change in 5-10-5 (Pro Agility) test time
Measured: 2-4 months
Change in horizontal jump distance
Average change in forward jumping distance
Measured: 2-4 months
Change in 10 meter forward run time
Average change in time spent running 10 meters
Measured: 2-4 months
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
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Jul 2022
- Primary completion30 Apr 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 671 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Community Foundation of Greater Flint
- Responsible party
- Principal investigator, William Suits, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442879
- Sponsor's protocol ID
- HUM00214282
- Status last verified
- Oct 2024
- First submitted
- 23 Jun 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Knowledge Translation Intervention With an ACL Prevention Program on Implementation, Injury Rates, and Performance in Youth Soccer Players
- ClinicalTrials.gov ID
- NCT05442879
- Acronym / sponsor ID
- HUM00214282
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 671 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Community Foundation of Greater Flint
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knowledge Translation Intervention | Experimental | Behavioral: Knowledge Translation InterventionThe 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. |
| Educational Handout | Active comparator | Behavioral: Educational handoutThe coaches will receive an educational handout describing an ACL-IPP. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Amateur youth soccer organizations within southern Michigan.
Key exclusion criteria (2 listed)
- Players above the age of 19 or below the age of 14
- Teams that have dedicated medical staffing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knowledge Translation InterventionThe 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. | Behavioural | Knowledge Translation Intervention |
| Educational handoutEducational handout describing a commonly cited ACL-IPP. | Behavioural | Educational Handout |
Primary outcome
Uptake of ACL-IPP
Time frame: up to 2 years
Reported frequency of implementation of ACL-IPP
Number of ACL injuries
Time frame: up to 2 years
4 secondary outcomes
Change in 5-10-5 test time
Time frame: 2-4 months
Change in horizontal jump distance
Time frame: 2-4 months
Change in 10 meter forward run time
Time frame: 2-4 months
Number of time-loss lower extremity injuries
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knowledge Translation Intervention and Educational handout in people with Anterior Cruciate Ligament Injuries and Lower Extremity Problem, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of ACL-IPP (time frame: up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.