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

Primary Purpose

Anterior Cruciate Ligament Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Application of an anterior cruciate ligament injury prevention protocol for female football players with dynamic knee valgus for 12 weeks.
Placebo - Conventional fitness programme
Sponsored by
Amanda Coves García
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anterior Cruciate Ligament Injuries focused on measuring Knee Injuries, Female, Football

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Miguel Hernandez University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

ACL injury prevention protocol

Arm Description

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

Participants in this group will undergo a specific 12-week prevention protocol.

Outcomes

Primary Outcome Measures

CHANGING RISK FACTORS
modification of risk factors such as dynamic knee valgus
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.
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.
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.
SPORTSWOMEN SATISFACTION
Changes in the incidence of injuries among female football players using the SF-12 satisfaction scale.

Secondary Outcome Measures

Full Information

First Posted
July 25, 2023
Last Updated
October 10, 2023
Sponsor
Amanda Coves García
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1. Study Identification

Unique Protocol Identification Number
NCT06083818
Brief Title
Anterior Cruciate Ligament Injury Prevention Protocol in Female Football Players With Dynamic Knee Valgus
Official Title
Therapeutic Exercise Protocol for the Prevention of Anterior Cruciate Ligament Injuries in Female Football Players With Dynamic Knee Valgus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amanda Coves García

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries
Keywords
Knee Injuries, Female, Football

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double blind masking
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in this group will undergo a conventional physical preparation programme.
Arm Title
ACL injury prevention protocol
Arm Type
Experimental
Arm Description
Participants in this group will undergo a specific 12-week prevention protocol.
Intervention Type
Other
Intervention Name(s)
Application of an anterior cruciate ligament injury prevention protocol for female football players with dynamic knee valgus for 12 weeks.
Intervention Description
12-week ACL Injury Prevention Protocol
Intervention Type
Other
Intervention Name(s)
Placebo - Conventional fitness programme
Intervention Description
Conventional training and physical preparation programme
Primary Outcome Measure Information:
Title
CHANGING RISK FACTORS
Description
modification of risk factors such as dynamic knee valgus
Time Frame
12 weeks
Title
MOTOR CONTROL
Description
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.
Time Frame
12 weeks
Title
SPORT PERFORMANCE
Description
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.
Time Frame
12 weeks
Title
KNEE JOINT BIOMECHANICS
Description
Changes in neuromuscular control of the knee using imaging and force plate assessments to monitor lower limb alignment and areas of increased reaction force.
Time Frame
12 weeks
Title
SPORTSWOMEN SATISFACTION
Description
Changes in the incidence of injuries among female football players using the SF-12 satisfaction scale.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Coves, Physiotherapy
Phone
651120701
Ext
+34
Email
amanda.coves@goumh.umh.es
Facility Information:
Facility Name
Miguel Hernandez University
City
San Juan De Alicante
State/Province
Alicante
ZIP/Postal Code
03550
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
Citation
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.
Results Reference
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Anterior Cruciate Ligament Injury Prevention Protocol in Female Football Players With Dynamic Knee Valgus

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