Physiological Effects of Soccer Heading

November 9, 2022 updated by: Children's Hospital of Philadelphia

Effect of Repetitive Soccer Heading on Biomechanics and Physiological Measures

There is growing concern for the resulting neurological and physiological outcomes from repeated head impacts in sports that do not manifest into traditional concussion symptoms. Specifically, there is evidence of immediate physiological deficits following controlled soccer heading. This study will compare the physiological changes of adolescents completing a set of soccer headers to those randomized to a set of soccer kicks to evaluate the effect of repetitive head impacts.

Study Overview

Detailed Description

There is limited data relating head impact biomechanics to neurological outcomes in humans. Concussion occurs from rotational loading of the head giving rise to diffuse stresses and strains in the brain tissue leading to autonomic and physiological dysfunction. Repeated head loading is common in contact sports and an integral part of soccer. It is unknown whether the same biomechanical forces from lower severity head impacts such as typical soccer heading cause temporary physiological deficits as well. Advancement of objective physiological function assessment devices allow measurement of neurological effects in the absence of diagnosed concussion. Recent soccer heading studies have evaluated neurophysiological changes pre- and post-repetitive heading. These studies have found conflicting results for the effect on neurocognitive performance immediately following a bout of heading, but consistent changes were observed in measures of vestibular balance, ocular function, and neurochemical biomarkers.

Soccer heading biomechanics studies showed that females experienced higher severity head loading, and in equivalent sports such as soccer and basketball, females have higher concussion rates. This study will compare the physiological changes of male and female adolescents completing one of two soccer heading paradigms to those randomized to kicking to evaluate the effect of repetitive head impacts. This study will relate biomechanical measures of head loading with physiological function changes associated with repeated head impacts, and compare sex-differences in biomechanical measures and physiological changes.

Study Type

Interventional

Enrollment (Actual)

27

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

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

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

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or females ages 13 to 18.
  • Actively participating on a competitive soccer team.
  • At least 1 year of soccer heading experience.
  • Parental/guardian permission (informed consent) and child assent.

Exclusion Criteria:

  • Subject sustained a concussion or spinal injury within the past 6 months or still has active symptoms from a previous injury.
  • Inability to exercise because of lower-extremity orthopedic injury or significant vestibular or visual dysfunction.
  • Currently taking medications that can affect autonomic function.
  • Plays exclusively the goalkeeper position and does not regularly head the ball.
  • Parental/guardian permission (informed consent) not obtainable or not provided.
  • Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
  • Subject has fixed orthodontia on upper teeth.
  • Cannot understand English.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Kicking
Subjects will complete a suite of clinical and neurophysiological assessments at 3 timepoints (Pre, 0-hour post, and 16-72 hour post soccer kicking intervention).
Subjects assigned to the soccer kicking arm will complete 10 soccer kicks in 10 minutes.
Experimental: Soccer Heading (Frontal)
Subjects will complete a suite of clinical and neurophysiological assessments at 3 timepoints (Pre, 0-hour post, and 16-72 hour post soccer heading intervention).
Subjects assigned to the soccer heading (frontal) arm will complete 10 frontal soccer headers (ball headed directly back to launch direction) in 10 minutes. Soccer balls will be projected at 10-17.5 m/s from approximately 10-15 m with a JUGS ball launcher.
Experimental: Soccer Heading (Oblique)
Subjects will complete a suite of clinical and neurophysiological assessments at 3 timepoints (Pre, 0-hour post, and 16-72 hour post soccer heading intervention).
Subjects assigned to the soccer heading (oblique) arm will complete 10 oblique soccer headers (ball headed 90° to the right from ball launch direction) in 10 minutes. Soccer balls will be projected at 10-17.5 m/s from approximately 10-15 m with a JUGS ball launcher.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinical Concussion Exam immediately post intervention
Time Frame: Pre-intervention to 0 hours post intervention
A standard concussion physical exam includes smooth pursuits, horizontal and vertical saccades, horizontal and vertical gaze stability, visual motion sensitivity, convergence and divergence, and tandem walk.
Pre-intervention to 0 hours post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Head linear acceleration
Time Frame: During Intervention
Linear acceleration (g) of the head will be measured during soccer heading via an instrumented mouthguard equipped with a 3-axis accelerometer.
During Intervention
Head angular velocity
Time Frame: During Intervention
Angular velocity (radians/second) of the head will be measured during soccer heading via an instrumented mouthguard equipped with a 3-axis gyroscope.
During Intervention
Change in Clinical Concussion Exam at up to 72 hours post intervention
Time Frame: Pre-intervention to between 16 and 72 hours post intervention
A standard concussion physical exam includes smooth pursuits, horizontal and vertical saccades, horizontal and vertical gaze stability, visual motion sensitivity, convergence and divergence, and tandem walk.
Pre-intervention to between 16 and 72 hours post intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
King-Devick Test
Time Frame: Pre-intervention, 0 hours post and up to 72 hours post intervention
The test assesses saccadic eye movement based on rapidly naming single-digit numbers from left to right on test cards, a laptop, or a tablet.
Pre-intervention, 0 hours post and up to 72 hours post intervention
Pupillary Light Reflex
Time Frame: Pre-intervention, 0 hours post and up to 72 hours post intervention
The dilation of the pupil in response to a visual stimulus
Pre-intervention, 0 hours post and up to 72 hours post intervention
Visual Evoked Potential
Time Frame: Pre-intervention, 0 hours post and up to 72 hours post intervention
The electrical brain activity in the entire vision system measured via surface electrodes following a reverse pattern visual stimulus.
Pre-intervention, 0 hours post and up to 72 hours post intervention
Balance
Time Frame: Pre-intervention, 0 hours post and up to 72 hours post intervention
Static balance will be assessed by the Biodex BioSway while standing on firm and foam surfaces with eyes open and closed.
Pre-intervention, 0 hours post and up to 72 hours post intervention
Neck Strength
Time Frame: Pre-intervention, 0 hours post and up to 72 hours post intervention
Maximum isometric voluntary contraction for neck flexion
Pre-intervention, 0 hours post and up to 72 hours post intervention
Muscle Activation
Time Frame: Pre-intervention, 0 hours post and up to 72 hours post intervention
Electromyography of the sternocleidomastoid and trapezius muscle activation during maximum isometric voluntary contraction and soccer kicking/heading.
Pre-intervention, 0 hours post and up to 72 hours post intervention

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Kristy B Arbogast, PhD, Children's Hospital of Philadelphia
  • Study Chair: Christina L Master, MD, Children's Hospital of Philadelphia

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 15, 2020

Primary Completion (Actual)

December 18, 2021

Study Completion (Actual)

December 19, 2021

Study Registration Dates

First Submitted

March 4, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 22, 2021

Study Record Updates

Last Update Posted (Actual)

November 10, 2022

Last Update Submitted That Met QC Criteria

November 9, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20-017267

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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