Anterior Cruciate Ligament Injury Prevention Protocol in Female Football Players With Dynamic Knee Valgus

November 27, 2023 updated by: Amanda Coves García

Therapeutic Exercise Protocol for the Prevention of Anterior Cruciate Ligament Injuries in Female Football Players With Dynamic Knee Valgus

Introduction: Women's football has experienced exponential growth over the last ten years. Its popularity is associated with an increase in anterior cruciate ligament injuries (ACL). They constitute a major current problem as they account for 43% of the injury burden during the sport season. Despite existing training programmes, no uniform criteria have been established to design a precise intervention protocol, with specific tasks linked to women's football, nor has it been proposed to optimise current programmes.

Objective: To evaluate the efficacy of a comprehensive and specific training protocol focused on female football players with dynamic knee valgus (DKV) to prevent ACL injuries.

Methodology: Randomised, double-blind, single-centre clinical trial protocol scheduled for the 2023-2024 season of women's football. There will be 2 groups: a group that will follow a specific ACL injury prevention protocol and a control group. The intervention period will last 12 weeks. Measurements will be taken at 3 time points. The biomechanics of the lower extremities, the dynamics of jumping and landing, as well as the pre and post training satisfaction of the players will be evaluated. Image capture and processing systems will be used in addition to tests such as the drop vertical jump test (DVJ), the LESS scoring system, among others.

Future expectations: This protocol aims to be one of the first to implement an ACL injury prevention programme for women football players with DKV. Despite the scarcity of research in this area, studies support beneficial effects at a preventive level.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Alicante
      • San Juan De Alicante, Alicante, Spain, 03550
        • Miguel Hernández University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female football players registered and federated in the corresponding team.
  • With an age range between 18 and 35 years old.
  • Minimum experience of one year playing football.
  • With DKV presence.

Exclusion Criteria:

  • Subjects with previous ACL or other ligamentous injury to the knee.
  • Subjects with a history of lower extremity injury resulting in surgery during the six months prior to the study.
  • Players with chronic illnesses that may affect test results.
  • Subjects who played other sports at a professional level.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants in this group will undergo a conventional physical preparation programme.
Other: Placebo - Conventional fitness programme
Conventional training and physical preparation programme
Experimental: ACL injury prevention protocol
Participants in this group will undergo a specific 12-week prevention protocol.
Other: Application of an anterior cruciate ligament injury prevention protocol for female football players with dynamic knee valgus for 12 weeks.
12-week ACL Injury Prevention Protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CHANGING RISK FACTORS
Time Frame: 12 weeks
modification of risk factors such as dynamic knee valgus
12 weeks
MOTOR CONTROL
Time Frame: 12 weeks
Changes in motor control not only of the lower limbs, but also of the lumbo-pelvic complex using software and imaging systems that measure joint alignments.
12 weeks
SPORT PERFORMANCE
Time Frame: 12 weeks
Tactical and technical changes are expected on the pitch as well as improvements in the sporting performance of the players through dynamic evaluations with imaging and video systems as well as speed and agility tests by monitoring joint stability.
12 weeks
KNEE JOINT BIOMECHANICS
Time Frame: 12 weeks
Changes in neuromuscular control of the knee using imaging and force plate assessments to monitor lower limb alignment and areas of increased reaction force.
12 weeks
SPORTSWOMEN SATISFACTION
Time Frame: 12 weeks
Changes in the incidence of injuries among female football players using the SF-12 satisfaction scale.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amanda Coves García

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Coves-García A, Lozano-Quijada C, Poveda-Pagán EJ. Strategies for the prevention of anterior cruciate ligament injuries in female athletes with dynamic knee valgus. Systematic review. Physiotherapy. doi:https://doi.org/10.1016/j.ft.2023.04.002.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

October 10, 2023

First Posted (Actual)

October 16, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04122022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data concerning the age, height and weight of the participants will be shared, as well as the variables that will be measured for the subsequent execution of the study.

A statistical analysis of the required variables will be carried out, in addition to explaining the data analysis system using statistical programmes. Informed consent will also be obtained from each of the participants in the study, specifying the collection of personal data for research and teaching purposes.

IPD Sharing Time Frame

Since the completion of the study and reporting of the study by publishing it in an international journal

IPD Sharing Access Criteria

Anyone who subscribes to the journal and who has access to the articles published in the journal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anterior Cruciate Ligament Injuries

Clinical Trials on Placebo - Conventional fitness programme

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe