Anterior Cruciate Ligament InjuriesNCT04062578
Effects Provided by a Physiotherapy Treatment Preventing Lower Extremity Injuries in Female Football Players
A study testing Physiotherapy program of lumbopelvic stabilization and strengthening of the hip region musculature in people with Anterior Cruciate Ligament Injuries and Injuries, Knee, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
Background and justification: Women's football has a percentage of knee injury of 31.8%, and the anterior cruciate ligament lesion is between 2 and 4 times higher than the male. Injury prevention programs seek to improve the control of the neuromuscular recruitment, dynamic valgus and lumbopelvic stabilization. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Injuries, Knee, Prevention & Control
- What is being tested?
- Physiotherapy program of lumbopelvic stabilization and strengthening of the hip region musculature
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 9 Sep 2019to 20 Jan 2020
- 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 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Have a valid federal license signed by the competent medical authority.
- Be part of a team registered in the federated league.
- Train 4 and a half hours a week or more.
- Compete and train in regulatory fields, with artificial grass.
- Have a staff composed of a qualified technician, registered and in possession of the corresponding validated license.
- Sign the informed consent.
Who cannot join
- Suffering a lower limb injury at the start of the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Loreto Ferrández Laliena
Zaragoza, 50004
Loreto F Laliena, Physiotheraphy, 666295923, loretousk@gmail.com
About this study
Official title: Effects Provided by a Physiotherapy Treatment Preventing Lower Extremity Injuries in Female Football Players: A Controlled Clinical Trial
Background and justification: Women's football has a percentage of knee injury of 31.8%, and the anterior cruciate ligament lesion is between 2 and 4 times higher than the male. Injury prevention programs seek to improve the control of the neuromuscular recruitment, dynamic valgus and lumbopelvic stabilization. Recently Cibulka and Bennett have proposed a new prevention theory based on the strengthening of the external abductor and hip rotator muscles. The objective of this study is to design and carry out a physiotherapy program based on the prevention of modifiable risks factors.
Design: Controlled clinical trial
Methodology: 2 groups were formed, the first or experimental integrated by the female players from football team called CD Oliver (CDO), and control, integrated by the female players of the first team SD Huesca (SDH). The investigators will carried out an initial and final evaluation in which they will be collected data on variables of injury incidence, muscle length and torque. A physiotherapy program will be implemented that will consider three areas of weekly action during training, preventive force sessions, compensatory force sessions and physiotherapy sessions.
- Being tested
- Physiotherapy program of lumbopelvic stabilization and strengthening of the hip region musculature
- Keywords
- Anterior Cruciate Ligament Injuries, Injuries, Knee, Female Football, Prevention & Control
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Knee Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy program of lumbopelvic stabilization and strengthening of the hip region musculatureBehavioural
The intervention program will begin in August, along with the 2019/2020 season, and will finish at the end of the first round (5-6 months). It will be applied to CD Oliver players in three weekly sessions: preventive force, compensatory force and physiotherapy attention. During this intervention period, the SD Huesca players, control group, continued with their usual training program. They will not implement any physiotherapy program like the designed one for the study.
| Study group | Role | What they receive |
|---|---|---|
| CD Oliver | Experimental | Female first team players of the club that plays in the National Second Division league. Receives: Behavioral: Physiotherapy program of lumbopelvic stabilization and strengthening of the hip region musculature |
| SD Huesca | Active comparator | Female first team players who play in the Aragonese Territorial First league Receives: Behavioral: Physiotherapy program of lumbopelvic stabilization and strengthening of the hip region musculature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the strength of hip musculature
Quadriceps Hamstrings internal and external hip rotators hip abductors Hip flexors Hip extensors
Measured: The measures will be taken at the beginning and at the end of the study (45 minutes per player)
Secondary outcomes (2)
Change in the muscle length test
Ely test (active and passive) Ober test (active and passive) Ake test Pake test
Measured: The measures will be taken at the beginning and at the end of the study (45 minutes per player)
Injuries Incidence
number and type of injuries
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start9 Sep 2019 (estimated)
- Primary completion20 Jan 2020 (estimated)
- Study completion20 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- In order to achieve the objectives of the study the investigators have chosen to conduct a controlled clinical trial. For the clinical trial they will define two intervention groups in collaboration with two women's soccer clubs: CD Oliver Urrutia and SD Huesca. They will carry out the physiotherapy program of lumbopelvic stabilization and strengthening of the musculature of the hip region carried out in the CD Oliver Urrutia (Zaragoza), club where the principal investigator will have a practice contract. The club will agree to implement the physiotherapy program in training with players from the Second National Division. The SD Huesca will be the control group, in which they will only perform the pre and post intervention measurements. The selected team was the first women's team of the club, which plays in group 1 of the Aragonese territorial league. When selecting football clubs, they will be taken into account the same profile of players and training.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Loreto Ferrández Laliena, Universidad de Zaragoza
- Investigators
- Loreto L Ferrández Laliena, Physiotheraphy, Principal investigator, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062578
- Sponsor's protocol ID
- PI18/383
- Status last verified
- Sep 2019
- First submitted
- 6 Aug 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Provided by a Physiotherapy Treatment Preventing Lower Extremity Injuries in Female Football Players: A Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04062578
- Acronym / sponsor ID
- PI18/383
- Keywords
- Anterior Cruciate Ligament Injuries, Injuries, Knee, Female Football, Prevention & Control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 9 Sep 2019 (estimated)
- Primary completion
- 20 Jan 2020 (estimated)
- Study completion
- 20 Jan 2020 (estimated)
- First posted
- 20 Aug 2019 (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.
Background and justification: Women's football has a percentage of knee injury of 31.8%, and the anterior cruciate ligament lesion is between 2 and 4 times higher than the male. Injury prevention programs seek to improve the control of the neuromuscular recruitment, dynamic valgus and lumbopelvic stabilization. Recently Cibulka and Bennett have proposed a new prevention theory based on the strengthening of the external abductor and hip rotator muscles. The objective of this study is to design and carry out a physiotherapy program based on the prevention of modifiable risks factors.
Design: Controlled clinical trial
Methodology: 2 groups were formed, the first or experimental integrated by the female players from football team called CD Oliver (CDO), and control, integrated by the female players of the first team SD Huesca (SDH). The investigators will carried out an initial and final evaluation in which they will be collected data on variables of injury incidence, muscle length and torque. A physiotherapy program will be implemented that will consider three areas of weekly action during training, preventive force sessions, compensatory force sessions and physiotherapy sessions.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In order to achieve the objectives of the study the investigators have chosen to conduct a controlled clinical trial. For the clinical trial they will define two intervention groups in collaboration with two women's soccer clubs: CD Oliver Urrutia and SD Huesca. They will carry out the physiotherapy program of lumbopelvic stabilization and strengthening of the musculature of the hip region carried out in the CD Oliver Urrutia (Zaragoza), club where the principal investigator will have a practice contract. The club will agree to implement the physiotherapy program in training with players from the Second National Division. The SD Huesca will be the control group, in which they will only perform the pre and post intervention measurements. The selected team was the first women's team of the club, which plays in group 1 of the Aragonese territorial league. When selecting football clubs, they will be taken into account the same profile of players and training.
| Arm | Type | Receives |
|---|---|---|
| CD Oliver | Experimental | Behavioral: Physiotherapy program of lumbopelvic stabilization and strengthening of the hip region musculatureFemale first team players of the club that plays in the National Second Division league. |
| SD Huesca | Active comparator | Behavioral: Physiotherapy program of lumbopelvic stabilization and strengthening of the hip region musculatureFemale first team players who play in the Aragonese Territorial First league |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Have a valid federal license signed by the competent medical authority.
- Be part of a team registered in the federated league.
- Train 4 and a half hours a week or more.
- Compete and train in regulatory fields, with artificial grass.
- Have a staff composed of a qualified technician, registered and in possession of the corresponding validated license.
Key exclusion criteria (1 listed)
- Suffering a lower limb injury at the start of the study.
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 |
|---|---|---|
| Physiotherapy program of lumbopelvic stabilization and strengthening of the hip region musculatureThe intervention program will begin in August, along with the 2019/2020 season, and will finish at the end of the first round (5-6 months). It will be applied to CD Oliver players in three weekly sessions: preventive force, compensatory force and physiotherapy attention. During this intervention period, the SD Huesca players, control group, continued with their usual training program. They will not implement any physiotherapy program like the designed one for the study. | Behavioural | CD Oliver, SD Huesca |
Primary outcome
Change in the strength of hip musculature
Time frame: The measures will be taken at the beginning and at the end of the study (45 minutes per player)
Quadriceps Hamstrings internal and external hip rotators hip abductors Hip flexors Hip extensors
2 secondary outcomes
Change in the muscle length test
Time frame: The measures will be taken at the beginning and at the end of the study (45 minutes per player)
Injuries Incidence
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
Loreto L Ferrández Laliena, Physiotheraphy principal investigator
Universidad de Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy program of lumbopelvic stabilization and strengthening of the hip region musculature in people with Anterior Cruciate Ligament Injuries and Injuries, Knee, run by Universidad de Zaragoza 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 6 inclusion and 1 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 4 Sep 2019. 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. 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 Loreto L Ferrández Laliena, Physiotherapy (+0034 666295923, loretousk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the strength of hip musculature (time frame: The measures will be taken at the beginning and at the end of the study (45 minutes per player)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2019.