Anterior Cruciate Ligament InjuriesNCT06083818
Anterior Cruciate Ligament Injury Prevention Protocol in Female Football Players With Dynamic Knee Valgus
A study testing Application of an anterior cruciate ligament injury prevention protocol for female football players with dynamic knee valgus for 12 weeks. in people with Anterior Cruciate Ligament Injuries, run by Amanda Coves García at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Application of an anterior cruciate ligament injury prevention protocol for female football players with dynamic knee valgus for 12 weeks.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Application of an anterior cruciate ligament injury prevention protocol for female football players with dynamic knee valgus for 12 weeks., Placebo - Conventional fitness programme
- Keywords
- Knee Injuries, Female, Football
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of an anterior cruciate ligament injury prevention protocol for female football players with dynamic knee valgus for 12 weeks.Other
12-week ACL Injury Prevention Protocol
Placebo - Conventional fitness programmeOther
Conventional training and physical preparation programme
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants in this group will undergo a conventional physical preparation programme. Receives: Other: Placebo - Conventional fitness programme |
| ACL injury prevention protocol | Experimental | Participants in this group will undergo a specific 12-week prevention protocol. Receives: Other: Application of an anterior cruciate ligament injury prevention protocol for female football players with dynamic knee valgus for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CHANGING RISK FACTORS
modification of risk factors such as dynamic knee valgus
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
SPORTSWOMEN SATISFACTION
Changes in the incidence of injuries among female football players using the SF-12 satisfaction scale.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study startOct 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amanda Coves García
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amanda Coves García, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083818
- Sponsor's protocol ID
- 04122022
- Status last verified
- Nov 2023
- First submitted
- 25 Jul 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
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.
PubMed 39881313
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Exercise Protocol for the Prevention of Anterior Cruciate Ligament Injuries in Female Football Players With Dynamic Knee Valgus
- ClinicalTrials.gov ID
- NCT06083818
- Acronym / sponsor ID
- 04122022
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- Knee Injuries, Female, Football
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Amanda Coves GarcíaUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo - Conventional fitness programmeParticipants in this group will undergo a conventional physical preparation programme. |
| ACL injury prevention protocol | Experimental | Other: Application of an anterior cruciate ligament injury prevention protocol for female football players with dynamic knee valgus for 12 weeks.Participants in this group will undergo a specific 12-week prevention protocol. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | ACL injury prevention protocol |
| Placebo - Conventional fitness programmeConventional training and physical preparation programme | Other | Placebo |
Primary outcome
CHANGING RISK FACTORS
Time frame: 12 weeks
modification of risk factors such as dynamic knee valgus
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.
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.
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.
SPORTSWOMEN SATISFACTION
Time frame: 12 weeks
Changes in the incidence of injuries among female football players using the SF-12 satisfaction scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- BackgroundCoves-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.
- Derived from this study: PubMed 39881313Garcia 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of an anterior cruciate ligament injury prevention protocol for female football players with dynamic knee valgus for 12 weeks. in people with Anterior Cruciate Ligament Injuries, run by Amanda Coves García at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amanda Coves, Physiotherapy (651120701 ext. +34, amanda.coves@goumh.umh.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CHANGING RISK FACTORS (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06083818, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.