NCT07019727

Brief Summary

This study aims to address the rising incidence of ACL injuries, particularly among adolescents, by developing and implementing a comprehensive prevention program based on the evidence-based "ACL Prevention for ALL" framework recommended by ESSKA-ESMA. The project focuses on muscle strengthening, flexibility, coordination, proper movement techniques, and a multidisciplinary approach involving coaches, physiotherapists, and physicians. Through targeted exercise modules, education, and dynamic evaluation-including 2D motion analysis-the study seeks to reduce ACL injuries, enhance movement safety, and enable individualized training plans by identifying and correcting muscle and biomechanical imbalances.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress58%
Jun 2025Dec 2026

First Submitted

Initial submission to the registry

June 5, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

June 12, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

September 30, 2025

Status Verified

June 1, 2025

Enrollment Period

7 months

First QC Date

June 5, 2025

Last Update Submit

September 29, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Peak knee abduction moment

    The strongest predictor of ACL injury risk according to the 'ligament dominance theory' and also the most frequently reported as changed after an IPP (Injury Prevention Program). Advantage: Quantifiable, measurable using 3D analysis and force platforms, and sensitive to changes.

    4 months

  • Peak knee flexion angle

    According to the 'quadriceps dominance theory,' a low angle increases the risk of ACL injury. Meta-analyses show an increase in the angle after IPP. Advantage: Easily measurable and consistently monitored in the literature.

    4 months

  • Dynamic knee valgus (DKV)

    Dynamic valgus is often described as a key injury mechanism, although its measurement is more complex and less standardized. It can be supplemented with specific angles such as knee abduction angle at initial contact (IC) and medial knee displacement.

    4 months

Secondary Outcomes (2)

  • Peak hip flexion angle & hip flexion at initial contact

    4 months

  • Vertical Ground Reaction Force (vGRF)

    4 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants of the program will attend a workshop led by a trained physiotherapist or strength and conditioning coach, conducted under medical supervision. Based on the ESSKA/ESMA methodology 'ACL Prevention for All', a total of 12 five-minute exercise units will be included.

Procedure: ESSKA/ESMA 'ACL Prevention for All' methodology

Control Group

NO INTERVENTION

The control group will consist of a total of 50 individuals from selected sports in which the prevention program will not be implemented. Testing in this group will take place at the same time as in the athletes undergoing the program, with a follow-up test conducted after four months.

Interventions

A workshop led by a trained physiotherapist/strength and conditioning coach and conducted under medical supervision. Based on the ESSKA/ESMA 'ACL Prevention for All' methodology, a total of 12 exercise units lasting 5 minutes each will be included.

Intervention Group

Eligibility Criteria

Age17 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age group: Participants aged 17-20 years
  • Sports activity: Individuals actively engaged in sports with a high risk of ACL injury
  • Health status: Participants with no or minimal previous knee joint injuries that do not limit their current physical activity
  • Willingness to participate: Agreement to take part in the prevention program, including regular training and assessments
  • Informed consent: Signed informed consent for participation in the program and testing procedures; for minors, consent must be signed by legal guardians

You may not qualify if:

  • Current injury: Individuals with a current knee joint injury requiring treatment or surgery
  • Chronic conditions: Participants with chronic diseases or conditions that may affect the outcome of injury prevention (e.g., congenital abnormalities, neuromuscular disorders, or cardiovascular diseases)
  • Insufficient consent: Individuals who are unable or unwilling to provide written informed consent
  • Irregular participation: Individuals who do not comply with regular participation in the training program or assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Masaryk University

Brno, 62700, Czechia

RECRUITING

Central Study Contacts

Michael Lujc, MUDr.

CONTACT

Filip Huceček, MUDr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2025

First Posted

June 13, 2025

Study Start

June 12, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

September 30, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations