Repeated Head ImpactsNCT04810130
Physiological Effects of Soccer Heading
A study testing Soccer Kicking, Soccer Heading (Frontal) and Soccer Heading (Oblique) in people with Repeated Head Impacts, run by Children's Hospital of Philadelphia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Repeated Head Impacts
- What is being tested?
- Soccer Kicking, Soccer Heading (Frontal) and Soccer Heading (Oblique)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2020to 19 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Effect of Repetitive Soccer Heading on Biomechanics and Physiological Measures
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.
Read the 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.
- Conditions
- Repeated Head Impacts
- Being tested
- Soccer Kicking, Soccer Heading (Frontal), Soccer Heading (Oblique)
- Keywords
- Soccer Heading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soccer KickingOther
Subjects assigned to the soccer kicking arm will complete 10 soccer kicks in 10 minutes.
Soccer Heading (Frontal)Other
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Kicking | Sham comparator | 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). Receives: Other: Soccer Kicking |
| Soccer Heading (Frontal) | Experimental | 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). Receives: Other: Soccer Heading (Frontal) |
| Soccer Heading (Oblique) | Experimental | 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). Receives: Other: Soccer Heading (Oblique) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-intervention to 0 hours post intervention
Secondary outcomes (3)
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.
Measured: During Intervention
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.
Measured: During Intervention
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.
Measured: Pre-intervention to between 16 and 72 hours post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start15 Dec 2020
- Primary completion18 Dec 2021
- Study completion19 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repeated Head ImpactsStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristy B Arbogast, PhD, Principal investigator, Children's Hospital of PhiladelphiaChristina L Master, MD, Study chair, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810130
- Sponsor's protocol ID
- 20-017267
- Status last verified
- Nov 2022
- First submitted
- 4 Mar 2021
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repetitive Soccer Heading on Biomechanics and Physiological Measures
- ClinicalTrials.gov ID
- NCT04810130
- Acronym / sponsor ID
- 20-017267
- Conditions
- Repeated Head Impacts
- Keywords
- Soccer Heading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 18 Dec 2021 (actual)
- Study completion
- 19 Dec 2021 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kicking | Sham comparator | Other: Soccer KickingSubjects will complete a suite of clinical and neurophysiological assessments at 3 timepoints (Pre, 0-hour post, and 16-72 hour post soccer kicking intervention). |
| Soccer Heading (Frontal) | Experimental | Other: 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). |
| Soccer Heading (Oblique) | Experimental | Other: 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). |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soccer KickingSubjects assigned to the soccer kicking arm will complete 10 soccer kicks in 10 minutes. | Other | Kicking |
| 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. | Other | Soccer Heading (Frontal) |
| 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. | Other | Soccer Heading (Oblique) |
Primary outcome
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.
3 secondary outcomes
Head linear acceleration
Time frame: During Intervention
Head angular velocity
Time frame: During Intervention
Change in Clinical Concussion Exam at up to 72 hours post intervention
Time frame: Pre-intervention to between 16 and 72 hours post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristy B Arbogast, PhD principal investigator
Children's Hospital of Philadelphia
Christina L Master, MD study chair
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soccer Kicking, Soccer Heading (Frontal) and Soccer Heading (Oblique) in people with Repeated Head Impacts, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Concussion Exam immediately post intervention (time frame: Pre-intervention to 0 hours post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022; AzTrials last refreshed its copy on 31 Oct 2026.