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

Primary Purpose

Anterior Cruciate Ligament Injuries, Injuries, Knee, Prevention & Control

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physiotherapy program of lumbopelvic stabilization and strengthening of the hip region musculature
Sponsored by
Universidad de Zaragoza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anterior Cruciate Ligament Injuries focused on measuring Anterior Cruciate Ligament Injuries, Injuries, Knee, Female Football, Prevention & Control

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Loreto Ferrández LalienaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CD Oliver

SD Huesca

Arm Description

Female first team players of the club that plays in the National Second Division league.

Female first team players who play in the Aragonese Territorial First league

Outcomes

Primary Outcome Measures

Change in the strength of hip musculature
Quadriceps Hamstrings internal and external hip rotators hip abductors Hip flexors Hip extensors

Secondary Outcome Measures

Change in the muscle length test
Ely test (active and passive) Ober test (active and passive) Ake test Pake test
Injuries Incidence
number and type of injuries

Full Information

First Posted
August 6, 2019
Last Updated
September 3, 2019
Sponsor
Universidad de Zaragoza
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1. Study Identification

Unique Protocol Identification Number
NCT04062578
Brief Title
Effects Provided by a Physiotherapy Treatment Preventing Lower Extremity Injuries in Female Football Players
Official Title
Effects Provided by a Physiotherapy Treatment Preventing Lower Extremity Injuries in Female Football Players: A Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 9, 2019 (Anticipated)
Primary Completion Date
January 20, 2020 (Anticipated)
Study Completion Date
January 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries, Injuries, Knee, Prevention & Control
Keywords
Anterior Cruciate Ligament Injuries, Injuries, Knee, Female Football, Prevention & Control

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CD Oliver
Arm Type
Experimental
Arm Description
Female first team players of the club that plays in the National Second Division league.
Arm Title
SD Huesca
Arm Type
Active Comparator
Arm Description
Female first team players who play in the Aragonese Territorial First league
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapy program of lumbopelvic stabilization and strengthening of the hip region musculature
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the strength of hip musculature
Description
Quadriceps Hamstrings internal and external hip rotators hip abductors Hip flexors Hip extensors
Time Frame
The measures will be taken at the beginning and at the end of the study (45 minutes per player)
Secondary Outcome Measure Information:
Title
Change in the muscle length test
Description
Ely test (active and passive) Ober test (active and passive) Ake test Pake test
Time Frame
The measures will be taken at the beginning and at the end of the study (45 minutes per player)
Title
Injuries Incidence
Description
number and type of injuries
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Loreto L Ferrández Laliena, Physiotherapy
Phone
+0034 666295923
Email
loretousk@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loreto L Ferrández Laliena, Physiotheraphy
Organizational Affiliation
Universidad de Zaragoza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loreto Ferrández Laliena
City
Zaragoza
ZIP/Postal Code
50004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loreto F Laliena, Physiotheraphy
Phone
666295923
Email
loretousk@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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