NCT04062578

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

September 9, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

4 months

First QC Date

August 6, 2019

Last Update Submit

September 3, 2019

Conditions

Keywords

Anterior Cruciate Ligament InjuriesInjuries, Knee, Female FootballPrevention & Control

Outcome Measures

Primary Outcomes (1)

  • Change in the strength of hip musculature

    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 Outcomes (2)

  • 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)

  • Injuries Incidence

    through study completion, an average of 1 year

Study Arms (2)

CD Oliver

EXPERIMENTAL

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

SD Huesca

ACTIVE COMPARATOR

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

Interventions

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.

CD OliverSD Huesca

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- Suffering a lower limb injury at the start of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loreto Ferrández Laliena

Zaragoza, 50004, Spain

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesKnee InjuriesWounds and Injuries

Condition Hierarchy (Ancestors)

Leg Injuries

Study Officials

  • Loreto L Ferrández Laliena, Physiotheraphy

    Universidad de Zaragoza

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Loreto L Ferrández Laliena, Physiotherapy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Student

Study Record Dates

First Submitted

August 6, 2019

First Posted

August 20, 2019

Study Start

September 9, 2019

Primary Completion

January 20, 2020

Study Completion

January 20, 2020

Last Updated

September 4, 2019

Record last verified: 2019-09

Locations