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

Sponsor
Universidad de Zaragoza (Other)
Overall Status
Unknown status
CT.gov ID
NCT04062578
Collaborator
(none)
35
Enrollment
1
Location
2
Arms
4.4
Anticipated Duration (Months)
8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Physiotherapy program of lumbopelvic stabilization and strengthening of the hip region musculature
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Prevention
Official Title:
Effects Provided by a Physiotherapy Treatment Preventing Lower Extremity Injuries in Female Football Players: A Controlled Clinical Trial
Anticipated Study Start Date :
Sep 9, 2019
Anticipated Primary Completion Date :
Jan 20, 2020
Anticipated Study Completion Date :
Jan 20, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: CD Oliver

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

Behavioral: Physiotherapy program of lumbopelvic stabilization and strengthening of the hip region musculature
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

Behavioral: Physiotherapy program of lumbopelvic stabilization and strengthening of the hip region musculature
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.

Outcome Measures

Primary Outcome Measures

  1. Change in the strength of hip musculature [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

Secondary Outcome Measures

  1. Change in the muscle length test [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

  2. Injuries Incidence [through study completion, an average of 1 year]

    number and type of injuries

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Loreto Ferrández Laliena Zaragoza Spain 50004

Sponsors and Collaborators

  • Universidad de Zaragoza

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Loreto Ferrández Laliena, Master Student, Universidad de Zaragoza
ClinicalTrials.gov Identifier:
NCT04062578
Other Study ID Numbers:
  • PI18/383
First Posted:
Aug 20, 2019
Last Update Posted:
Sep 4, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Loreto Ferrández Laliena, Master Student, Universidad de Zaragoza
Anterior Cruciate Ligament Injuries
Injuries, Knee, Female Football
Prevention & Control
Additional relevant MeSH terms:
Wounds and Injuries
Anterior Cruciate Ligament Injuries
Knee Injuries

Study Results

No Results Posted as of Sep 4, 2019