- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04810130
Physiological Effects of Soccer Heading
Effect of Repetitive Soccer Heading on Biomechanics and Physiological Measures
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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).
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Subjects assigned to the soccer kicking arm will complete 10 soccer kicks in 10 minutes.
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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).
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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.
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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).
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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.
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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
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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.
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Pre-intervention to 0 hours post intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Head linear acceleration
Time Frame: During Intervention
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Linear acceleration (g) of the head will be measured during soccer heading via an instrumented mouthguard equipped with a 3-axis accelerometer.
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During Intervention
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Head angular velocity
Time Frame: During Intervention
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Angular velocity (radians/second) of the head will be measured during soccer heading via an instrumented mouthguard equipped with a 3-axis gyroscope.
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During Intervention
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Change in Clinical Concussion Exam at up to 72 hours post intervention
Time Frame: Pre-intervention to between 16 and 72 hours post intervention
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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.
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Pre-intervention to between 16 and 72 hours post intervention
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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
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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.
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Pre-intervention, 0 hours post and up to 72 hours post intervention
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Pupillary Light Reflex
Time Frame: Pre-intervention, 0 hours post and up to 72 hours post intervention
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The dilation of the pupil in response to a visual stimulus
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Pre-intervention, 0 hours post and up to 72 hours post intervention
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Visual Evoked Potential
Time Frame: Pre-intervention, 0 hours post and up to 72 hours post intervention
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The electrical brain activity in the entire vision system measured via surface electrodes following a reverse pattern visual stimulus.
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Pre-intervention, 0 hours post and up to 72 hours post intervention
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Balance
Time Frame: Pre-intervention, 0 hours post and up to 72 hours post intervention
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Static balance will be assessed by the Biodex BioSway while standing on firm and foam surfaces with eyes open and closed.
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Pre-intervention, 0 hours post and up to 72 hours post intervention
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Neck Strength
Time Frame: Pre-intervention, 0 hours post and up to 72 hours post intervention
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Maximum isometric voluntary contraction for neck flexion
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Pre-intervention, 0 hours post and up to 72 hours post intervention
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Muscle Activation
Time Frame: Pre-intervention, 0 hours post and up to 72 hours post intervention
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Electromyography of the sternocleidomastoid and trapezius muscle activation during maximum isometric voluntary contraction and soccer kicking/heading.
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Pre-intervention, 0 hours post and up to 72 hours post intervention
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Collaborators and Investigators
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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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