Clinical trial NCT04810130: Physiological Effects of Soccer Heading
Official title: Effect of Repetitive Soccer Heading on Biomechanics and Physiological Measures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Repeated Head Impacts
Keywords: Soccer Heading
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 27
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Clinical Concussion Exam immediately post intervention
timeFrame: Pre-intervention to 0 hours post intervention
Secondary outcomes:
measure: Head linear acceleration
timeFrame: During Intervention
measure: Head angular velocity
timeFrame: During Intervention
measure: Change in Clinical Concussion Exam at up to 72 hours post intervention
timeFrame: Pre-intervention to between 16 and 72 hours post intervention
Other outcomes:
measure: King-Devick Test
timeFrame: Pre-intervention, 0 hours post and up to 72 hours post intervention
measure: Pupillary Light Reflex
timeFrame: Pre-intervention, 0 hours post and up to 72 hours post intervention
measure: Visual Evoked Potential
timeFrame: Pre-intervention, 0 hours post and up to 72 hours post intervention
measure: Balance
timeFrame: Pre-intervention, 0 hours post and up to 72 hours post intervention
measure: Neck Strength
timeFrame: Pre-intervention, 0 hours post and up to 72 hours post intervention
measure: Muscle Activation
timeFrame: Pre-intervention, 0 hours post and up to 72 hours post intervention
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Kristy B Arbogast, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Christina L Master, MD
role: STUDY_CHAIR
References: