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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04062578
Other study ID # PI18/383
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 9, 2019
Est. completion date January 20, 2020

Study information

Verified date September 2019
Source Universidad de Zaragoza
Contact Loreto L Ferrández Laliena, Physiotherapy
Phone +0034 666295923
Email loretousk@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 35
Est. completion date January 20, 2020
Est. primary completion date January 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Spain Loreto Ferrández Laliena Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in the muscle length test 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)
Secondary Injuries Incidence number and type of injuries through study completion, an average of 1 year
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