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Clinical Trials/NCT04810130
NCT04810130CompletedNot Applicable

Effect of Repetitive Soccer Heading on Biomechanics and Physiological Measures

Children's Hospital of Philadelphia2 sites in 1 country27 target enrollmentStarted: December 15, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
27
Locations
2
Primary Endpoint
Change in Clinical Concussion Exam immediately post intervention

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
13 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Males or females ages 13 to
  • 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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Head angular velocity(During Intervention)
  • Change in Clinical Concussion Exam at up to 72 hours post intervention(Pre-intervention to between 16 and 72 hours post intervention)
  • Head linear acceleration(During Intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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