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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06136299
Other study ID # Pro00036803
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 7, 2022
Est. completion date May 20, 2023

Study information

Verified date November 2023
Source The Methodist Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date May 20, 2023
Est. primary completion date May 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 8 Years to 11 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Houston Methodist Hospital Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The Methodist Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
Primary 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).
Primary 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).
Primary 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).
Primary 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 Injury rates Injury information provided by coaches and/or parents throughout the spring soccer season. Duration of spring soccer season, January - May (5 months).
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