Effects Provided by a Physiotherapy Treatment Preventing Lower Extremity Injuries in Female Football Players

September 3, 2019 updated by: Loreto Ferrández Laliena, Universidad de Zaragoza

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

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zaragoza, Spain, 50004
        • Recruiting
        • Loreto Ferrández Laliena
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)

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
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
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Loreto L Ferrández Laliena, Physiotheraphy, Universidad de Zaragoza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 9, 2019

Primary Completion (Anticipated)

January 20, 2020

Study Completion (Anticipated)

January 20, 2020

Study Registration Dates

First Submitted

August 6, 2019

First Submitted That Met QC Criteria

August 16, 2019

First Posted (Actual)

August 20, 2019

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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