NCT06136299

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

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

December 7, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

November 1, 2023

Last Update Submit

November 14, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • Dynamic balance assessment

    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

    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

    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

    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

    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 Outcomes (1)

  • Injury rates

    Duration of spring soccer season, January - May (5 months).

Study Arms (2)

Control - Standard warm-up

NO INTERVENTION

This group performed a standard warm-up protocol during their soccer practice sessions.

Intervention - NMT

EXPERIMENTAL

This group performed a specific Neuromuscular Training (NMT) warm-up program known as FIFA 11+ Kids during their soccer practice sessions

Other: Neuromuscular Training

Interventions

This intervention uses the FIFA 11+ Kids program as a warm-up during soccer practice sessions.

Intervention - NMT

Eligibility Criteria

Age8 Years - 11 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Athletic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Shari Liberman, MD

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All staff members measuring performance at the pre- and post-intervention testing sessions were unaware of which group the subject was randomized to.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: There are two groups for this study. The control group performs their standard warm-up during soccer practice sessions and the experimental group performs neuromuscular training (NMT) in the form of the FIFA 11+ Kids program as their warm up.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 1, 2023

First Posted

November 18, 2023

Study Start

December 7, 2022

Primary Completion

May 20, 2023

Study Completion

May 20, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations