- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06136299
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
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
Interventional
Enrollment (Actual)
93
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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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
|
This intervention uses the FIFA 11+ Kids program as a warm-up during soccer practice sessions.
|
What is the study measuring?
Primary Outcome Measures
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).
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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
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.
Investigators
- 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)
December 7, 2022
Primary Completion (Actual)
May 20, 2023
Study Completion (Actual)
May 20, 2023
Study Registration Dates
First Submitted
November 1, 2023
First Submitted That Met QC Criteria
November 14, 2023
First Posted (Estimated)
November 17, 2023
Study Record Updates
Last Update Posted (Estimated)
November 17, 2023
Last Update Submitted That Met QC Criteria
November 14, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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