Neuromuscular Training in Female Youth Soccer (NMT)

November 14, 2023 updated by: Shari Liberman, The Methodist Hospital Research Institute

Effect of Neuromuscular Training on Physical Performance and Injury Rate in Elite Female Youth Soccer Players

The goal of this clinical trial is to analyze the effectiveness of an NMT-based, injury prevention training program ('FIFA 11+ for Kids') in pre-adolescent (Ages 8 to 11) elite female soccer players by measuring neuromuscular control and motor coordination through pre-intervention and post-intervention testing. As well as monitoring the incidence of injury throughout a soccer season.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will recruit females aged between 8-11 from several teams within a large, competitive elite soccer club. Whole teams will be assigned to either the intervention group or an age-matched control group. Participants will be informed which group they will be placed in prior to participation in the research study. As directed by their respective coaches, the intervention group will receive neuromuscular training (NMT) through an already established, validated protocol (FIFA 11+ Kids); whilst the control group will perform their standard warm-up during soccer practice sessions. The program will last for the duration of the spring soccer season (January - May 2023; 5 months). All study participants will be required to attend two evaluation sessions (pre-intervention and post-intervention) in order to measure performance in speed, agility, hop testing, dynamic balance and strength.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
93

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Elite female soccer players aged 8-11.
  • Member of an elite youth soccer club.

Exclusion Criteria:

  • Female not aged 8-11 years old.
  • Not a member of a youth soccer club.
  • Unable to attend the pre-intervention or post-intervention evaluation, for reasons other than injury.
  • Unable to attend 80% or more of scheduled training sessions.
  • If a participant discontinues playing soccer they will be excluded.
  • Declines to participate in 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control - Standard warm-up
This group performed a standard warm-up protocol during their soccer practice sessions.
Experimental: Intervention - NMT
This group performed a specific Neuromuscular Training (NMT) warm-up program known as FIFA 11+ Kids during their soccer practice sessions
Other: Neuromuscular Training
This intervention uses the FIFA 11+ Kids program as a warm-up during soccer practice sessions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dynamic balance assessment
Time Frame: Dynamic balance will be measured at two separate timepoints: pre-intervention (baseline) and post-intervention (within 5-months after baseline measures).
The Y-balance test is a standardized protocol consisting of lower extremity reach in the anterior, posteromedial and posterolateral directions.
Dynamic balance will be measured at two separate timepoints: pre-intervention (baseline) and post-intervention (within 5-months after baseline measures).
Strength assessment
Time Frame: Strength will be measured at two separate timepoints: pre-intervention (baseline) and post-intervention (within 5-months after baseline measures).
Hamstring and quadriceps strength will be measured using a handheld dynamometer. Each strength measure will be taken 3 times with the average calculated.
Strength will be measured at two separate timepoints: pre-intervention (baseline) and post-intervention (within 5-months after baseline measures).
Agility assessment
Time Frame: Agility will be measured at two separate timepoints: pre-intervention (baseline) and post-intervention (within 5-months after baseline measures).
The Pro-Agility Test utilizes three cones. The farthest cone is sprinted to, the ground is touched with one hand and direction changed back to the starting cone (9.1m sprint). The ground is touched at the starting cone, direction is changed to the 'middle cone' into a 4.6m sprint. Passing the 'middle cone' is the finish line for the test. Each strength measure will be taken 3 times with the average calculated.
Agility will be measured at two separate timepoints: pre-intervention (baseline) and post-intervention (within 5-months after baseline measures).
Hop testing assessment
Time Frame: Hop performance will be measured at two separate timepoints: pre-intervention (baseline) and post-intervention (within 5-months after baseline measures).
Participants will complete a single leg hop, triple hop and a timed 6 meter hop
Hop performance will be measured at two separate timepoints: pre-intervention (baseline) and post-intervention (within 5-months after baseline measures).
Kinetic jump testing assessment
Time Frame: Kinetic jump performance will be measured at two separate timepoints: pre-intervention (baseline) and post-intervention (within 5-months after baseline measures).
A countermovement jump and a single leg vertical jump on a force plate platform system.
Kinetic jump performance will be measured at two separate timepoints: pre-intervention (baseline) and post-intervention (within 5-months after baseline measures).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Injury rates
Time Frame: Duration of spring soccer season, January - May (5 months).
Injury information provided by coaches and/or parents throughout the spring soccer season.
Duration of spring soccer season, January - May (5 months).

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Methodist Hospital Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shari Liberman, MD, The Methodist Hospital Research Institute

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00036803

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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