Physiological Effects of Soccer Heading

Repeated Head Impacts Clinical Trial

Official title:

Effect of Repetitive Soccer Heading on Biomechanics and Physiological Measures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04810130
• Other study ID #: 20-017267
• Status: Completed
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: December 19, 2021

Study information

• Verified date: November 2022
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 19, 2021
• Est. primary completion date: December 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Repeated Head Impacts

Intervention

Other:
• Soccer Kicking
Subjects assigned to the soccer kicking arm will complete 10 soccer kicks in 10 minutes.
• Soccer Heading (Frontal)
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.
• Soccer Heading (Oblique)
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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	King-Devick Test	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
Other	Pupillary Light Reflex	The dilation of the pupil in response to a visual stimulus	Pre-intervention, 0 hours post and up to 72 hours post intervention
Other	Visual Evoked Potential	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
Other	Balance	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
Other	Neck Strength	Maximum isometric voluntary contraction for neck flexion	Pre-intervention, 0 hours post and up to 72 hours post intervention
Other	Muscle Activation	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
Primary	Change in Clinical Concussion Exam immediately 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	Head linear acceleration	Linear acceleration (g) of the head will be measured during soccer heading via an instrumented mouthguard equipped with a 3-axis accelerometer.	During Intervention
Secondary	Head angular velocity	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
Secondary	Change in Clinical Concussion Exam at up to 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