NCT05688930

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 7, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2021

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

October 19, 2021

Last Update Submit

January 8, 2023

Conditions

Keywords

Ankle injuriesPhysical therapyNeuromuscular trainingFunctional ankle instabilityPreventionUnstable joint.

Outcome Measures

Primary Outcomes (1)

  • Preventive program (Type of)

    Neuromuscular and functional training protocol

    12 weeks

Secondary Outcomes (4)

  • Ankle instability perception

    Two measurements: first week and twelfth week

  • Measurement flexibility (centimeters)

    Two measurements: first week and twelfth week

  • Limits of stability - balance (millimeters)

    Two measurements: first week and twelfth week

  • Measured with conduction velocity in seconds under maximal voluntary contraction (MVC)

    Two measurements: first week and twelfth week

Study Arms (2)

PENMT (Experimental Group)

EXPERIMENTAL

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)

FIFA 11+ (Control Group)

ACTIVE COMPARATOR

Treatment or experimental condition. 1: FIFA 11+ Program

Other: FIFA 11+ (Control Group)

Interventions

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.

PENMT (Experimental Group)

Treatment or experimental condition. 1: FIFA 11+ Program

FIFA 11+ (Control Group)

Eligibility Criteria

Age17 Years - 20 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Autonoma's University

Manizales, Caldas Department, 170000, Colombia

Location

Related Publications (3)

  • Brito J, Malina RM, Seabra A, Massada JL, Soares JM, Krustrup P, Rebelo A. Injuries in Portuguese youth soccer players during training and match play. J Athl Train. 2012 Mar-Apr;47(2):191-7. doi: 10.4085/1062-6050-47.2.191.

    PMID: 22488285BACKGROUND
  • Imai A, Imai T, Iizuka S, Kaneoka K. A Trunk Stabilization Exercise Warm-up May Reduce Ankle Injuries in Junior Soccer Players. Int J Sports Med. 2018 Apr;39(4):270-274. doi: 10.1055/s-0044-100923. Epub 2018 Feb 15.

    PMID: 29448292BACKGROUND
  • Halasi T, Kynsburg A, Tallay A, Berkes I. Changes in joint position sense after surgically treated chronic lateral ankle instability. Br J Sports Med. 2005 Nov;39(11):818-24. doi: 10.1136/bjsm.2004.016527.

    PMID: 16244190BACKGROUND

MeSH Terms

Conditions

Ankle InjuriesJoint Instability

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesJoint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Lina Ma Montealegre, Msc

    U.AUTÓNOMA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: G1: Neuromuscular training program of prevention of functional ankle instability PEMNT; G2: FIFA 11+ Program Group (control).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2021

First Posted

January 18, 2023

Study Start

July 7, 2021

Primary Completion

November 7, 2021

Study Completion

July 1, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations