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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06083818
Other study ID # 04122022
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2024
Est. completion date July 2025

Study information

Verified date November 2023
Source Universidad Miguel Hernandez de Elche
Contact Amanda Coves, Physiotherapy
Phone 651120701
Email amanda.coves@goumh.umh.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 48
Est. completion date July 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
Placebo - Conventional fitness programme
Conventional training and physical preparation programme

Locations

Country Name City State
Spain Miguel Hernandez University San Juan De Alicante Alicante

Sponsors (1)

Lead Sponsor Collaborator
Amanda Coves García

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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.

Outcome

Type Measure Description Time frame Safety issue
Primary CHANGING RISK FACTORS modification of risk factors such as dynamic knee valgus 12 weeks
Primary 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
Primary 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
Primary 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
Primary SPORTSWOMEN SATISFACTION Changes in the incidence of injuries among female football players using the SF-12 satisfaction scale. 12 weeks
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