Effects of a Neuromuscular Training Ankle Preventive Program in Soccer Player (PENT)

January 8, 2023 updated by: Universidad Autónoma de Manizales, Colombia

Effects of a Neuromuscular Training Program for the Prevention of Ankle Functional Instability in Male Soccer Players Aged 17-20: Randomized Clinical Trial With FIFA 11+

Objetive:To determine the effects of a functional ankle instability prevention neuromuscular training (PENMT) program compared to the conventional FIFA 11+ program on the occurrence of ankle sprains, flexibility, balance and muscle activation in 17-year-old male youth soccer players to 20 years.

Subjects and Methods: An experimental investigation, controlled, randomized and single-blind clinical trial was carried out in 40 subjects randomized to start the control or experimental group (soccer Players). The trial compared the effects of a differential intervention with a protocol focused on an ankle neuromuscular training program vs the usual FIFA 11+ program, in order to strengthen functional ankle stability in youth soccer in male players. In each subject, 2 measurements were taken: Pre-intervention and Post-intervention. For each measurement, a hypothesis test was performed.

Results: The FIFA11+ is expressed as an injury risk factor when buying it with the PENMT after their participation.

Conclusion:The neuromuscular training program for the ankle or PENMT applied in the experimental group did not generate a negative effect with respect to the FIFA 11+ program, in addition to the time of departure in the post test, the PENMT program is expressed as a protection factor of player injuries when contrasted with the FIFA 11+ program, that is, it presents effectiveness against the risk factor of functional ankle instability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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

  • Colombia
    • Caldas
      • Manizales, Caldas, Colombia, 170000
        • Autonoma's University

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

17 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Be between the age range of 17 to 20 years old at the time of evaluation and intervention.
  • Have a minimum of 2 years of semi-professional / professional sports practice.
  • Be linked to the football club for at least 1 year.
  • That they practice soccer at least 5 times a week.
  • That they are playing at least one competitive tournament.
  • That they have an active or current health promotion entity - EPS and / or occupational risk insurer-ARL.
  • Players who during the entire period of 2019-2020 have presented at least one episode of lateral ankle sprain (during the last 4 months) (in the time range of 3 to 12 months prior to the first evaluation) who have required immobilization and / or weight loss for at least 3 days; present pain, subjective perception questionnaires of ankle instability).
  • Soccer players with or without sprained ankle injuries will be taken, but not in the last 3 months. However, the time elapsed since the last episode will be recorded.

Exclusion Criteria:

  • Belonging to another sports club and / or regularly practicing more than one sport with muscular demand of the lower tract (lower limbs).
  • Who present acute injuries such as: vestibular alterations, history of ankle fracture, acute knee and / or ankle injury during the last 3 months, history of previous surgical interventions in lower limbs or underlying systemic disease at the time of the initial evaluation (pretest).
  • Who are undergoing treatment for any neuromuscular or other related pathology, in the acute phase and / or who have received a neuromuscular training program in the last 4 months, different from the one that will be applied in this study.
  • That in the last 4 months they have been in treatment for any neuromuscular pathology or other related to the acute phase and / or receive a neuromuscular training program different from the one that will be applied in this 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PENMT (Experimental Group)
The neuromuscular injury prevention intervention protocol contains field work activities that involve proprioceptive exercises, flexibility, and specific and general muscle strength of the MMII and trunk.
Other: PENMT (Experimental Group)
The neuromuscular injury prevention intervention protocol contains field work activities that involve proprioceptive exercises, flexibility, and specific and general muscle strength of the MMII and trunk soccer players.
Active Comparator: FIFA 11+ (Control Group)
Treatment or experimental condition. 1: FIFA 11+ Program
Other: FIFA 11+ (Control Group)
Treatment or experimental condition. 1: FIFA 11+ Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preventive program (Type of)
Time Frame: 12 weeks
Neuromuscular and functional training protocol
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ankle instability perception
Time Frame: Two measurements: first week and twelfth week
Two measures were performed for each patient; Cumberland Ankle Instability Questionnaire (CAIT): 30 points no instability; less than 27 points presence of ankle instability. (applied pre and post intervention moments)
Two measurements: first week and twelfth week
Measurement flexibility (centimeters)
Time Frame: Two measurements: first week and twelfth week
Two measures were performed for each patient; of the ankle joint (Lunge test) and chain of the lower limb (sit and reach: (BSSR); measurement in centimeters (cm), report of negative values or less than 0 cm, presence of retraction was lost. Both before and after the test.(applied pre and post intervention moments)
Two measurements: first week and twelfth week
Limits of stability - balance (millimeters)
Time Frame: Two measurements: first week and twelfth week
Two measures were performed for each patient;Dynamic and static balance with eyes open and closed, in a movement analysis laboratory, measured in millimeters -mm. (Applied moments pre and post intervention)
Two measurements: first week and twelfth week
Measured with conduction velocity in seconds under maximal voluntary contraction (MVC)
Time Frame: Two measurements: first week and twelfth week
Two measures were performed for each patient; surface electromyography, musculature - at 25 percentage, 50 percentage and 75 percentage of muscle activation. (moments before and after the intervention).
Two measurements: first week and twelfth week

Collaborators and Investigators

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

Sponsor

Universidad Autónoma de Manizales, Colombia

Collaborators

Universidad Católica del Maule

Investigators

  • Principal Investigator: Lina Ma Montealegre, Msc, U.AUTÓNOMA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

July 7, 2021

Primary Completion (Actual)

November 7, 2021

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

October 19, 2021

First Submitted That Met QC Criteria

January 8, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 8, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 703-2020 T.D.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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