Injury;SportsNMTNCT06136299
Neuromuscular Training in Female Youth Soccer
A study testing Neuromuscular Training in people with Injury;Sports, run by The Methodist Hospital Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 11 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Injury;Sports
- What is being tested?
- Neuromuscular Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2022to 20 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Elite female soccer players aged 8-11.
- Member of an elite youth soccer club.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Injury;Sports
- Being tested
- Neuromuscular Training
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular TrainingOther
This intervention uses the FIFA 11+ Kids program as a warm-up during soccer practice sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Neuromuscular Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic balance assessment
The Y-balance test is a standardized protocol consisting of lower extremity reach in the anterior, posteromedial and posterolateral directions.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Injury information provided by coaches and/or parents throughout the spring soccer season.
Measured: Duration of spring soccer season, January - May (5 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start7 Dec 2022
- Primary completion20 May 2023
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury;SportsStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shari Liberman, The Methodist Hospital Research Institute
- Investigators
- Shari Liberman, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136299
- Sponsor's protocol ID
- Pro00036803
- Acronym
- NMT
- Status last verified
- Nov 2023
- First submitted
- 1 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromuscular Training on Physical Performance and Injury Rate in Elite Female Youth Soccer Players
- ClinicalTrials.gov ID
- NCT06136299
- Acronym / sponsor ID
- NMT / Pro00036803
- Conditions
- Injury;Sports
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control - Standard warm-up | No intervention | –This group performed a standard warm-up protocol during their soccer practice sessions. |
| Intervention - NMT | Experimental | Other: Neuromuscular TrainingThis group performed a specific Neuromuscular Training (NMT) warm-up program known as FIFA 11+ Kids during their soccer practice sessions |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Elite female soccer players aged 8-11.
- Member of an elite youth soccer club.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular TrainingThis intervention uses the FIFA 11+ Kids program as a warm-up during soccer practice sessions. | Other | Intervention - NMT |
Primary outcome
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.
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.
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.
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
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.
1 secondary outcome
Injury rates
Time frame: Duration of spring soccer season, January - May (5 months).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shari Liberman, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Training in people with Injury;Sports, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.