- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04062578
Effects Provided by a Physiotherapy Treatment Preventing Lower Extremity Injuries in Female Football Players
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.
Study Overview
Status
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Zaragoza, Spain, 50004
- Recruiting
- Loreto Ferrández Laliena
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Contact:
- Loreto F Laliena, Physiotheraphy
- Phone Number: 666295923
- Email: loretousk@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Suffering a lower limb injury at the start of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CD Oliver
Female first team players of the club that plays in the National Second Division league.
|
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.
|
|
Active Comparator: SD Huesca
Female first team players who play in the Aragonese Territorial First league
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
The measures will be taken at the beginning and at the end of the study (45 minutes per player)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Ely test (active and passive) Ober test (active and passive) Ake test Pake test
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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
|
number and type of injuries
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through study completion, an average of 1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Loreto L Ferrández Laliena, Physiotheraphy, Universidad de Zaragoza
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI18/383
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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