Viewing Study NCT04810130



Ignite Creation Date: 2024-05-06 @ 3:57 PM
Last Modification Date: 2024-10-26 @ 2:00 PM
Study NCT ID: NCT04810130
Status: COMPLETED
Last Update Posted: 2022-11-10
First Post: 2021-03-04

Brief Title: Physiological Effects of Soccer Heading
Sponsor: Childrens Hospital of Philadelphia
Organization: Childrens Hospital of Philadelphia

Study Overview

Official Title: Effect of Repetitive Soccer Heading on Biomechanics and Physiological Measures
Status: COMPLETED
Status Verified Date: 2022-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None