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

Sponsor
Amanda Coves García (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06083818
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
9
Anticipated Duration (Months)
5.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Application of an anterior cruciate ligament injury prevention protocol for female football players with dynamic knee valgus for 12 weeks.
  • Other: Placebo - Conventional fitness programme
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Double blind masking
Primary Purpose:
Prevention
Official Title:
Therapeutic Exercise Protocol for the Prevention of Anterior Cruciate Ligament Injuries in Female Football Players With Dynamic Knee Valgus
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. CHANGING RISK FACTORS [12 weeks]

    modification of risk factors such as dynamic knee valgus

  2. MOTOR CONTROL [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.

  3. SPORT PERFORMANCE [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.

  4. KNEE JOINT BIOMECHANICS [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.

  5. SPORTSWOMEN SATISFACTION [12 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Miguel Hernandez University San Juan De Alicante Alicante Spain 03550

Sponsors and Collaborators

  • Amanda Coves García

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Amanda Coves García, Principal Investigator, Universidad Miguel Hernandez de Elche
ClinicalTrials.gov Identifier:
NCT06083818
Other Study ID Numbers:
  • 04122022
First Posted:
Oct 16, 2023
Last Update Posted:
Oct 16, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Amanda Coves García, Principal Investigator, Universidad Miguel Hernandez de Elche
Knee Injuries
Female
Football
Additional relevant MeSH terms:
Wounds and Injuries
Anterior Cruciate Ligament Injuries

Study Results

No Results Posted as of Oct 16, 2023