NCT06083818

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

July 25, 2023

Last Update Submit

November 27, 2023

Conditions

Keywords

Knee InjuriesFemaleFootball

Outcome Measures

Primary Outcomes (5)

  • CHANGING RISK FACTORS

    modification of risk factors such as dynamic knee valgus

    12 weeks

  • MOTOR CONTROL

    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

    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

    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

    Changes in the incidence of injuries among female football players using the SF-12 satisfaction scale.

    12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants in this group will undergo a conventional physical preparation programme.

Other: Placebo - Conventional fitness programme

ACL injury prevention protocol

EXPERIMENTAL

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.

Interventions

Conventional training and physical preparation programme

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miguel Hernandez University

Sant Joan d'Alacant, Alicante, 03550, Spain

Location

Related Publications (2)

  • 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.

    BACKGROUND
  • Garcia AC, Pagan EJP. Therapeutic exercise protocol for the prevention of anterior cruciate ligament injuries in female soccer players with dynamic knee valgus (RCT). Trials. 2025 Jan 29;26(1):29. doi: 10.1186/s13063-025-08736-7.

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesKnee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Central Study Contacts

Amanda Coves, Physiotherapy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double blind masking
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 25, 2023

First Posted

October 16, 2023

Study Start

October 1, 2024

Primary Completion

April 1, 2025

Study Completion

July 1, 2025

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Since the completion of the study and reporting of the study by publishing it in an international journal
Access Criteria
Anyone who subscribes to the journal and who has access to the articles published in the journal

Locations