Sport-related ConcussionNCT03883165
How do the Neck Muscles Influence Head Acceleration During Sport-associated Impact Events in High School Athletes?
A study testing high-intensity neck strengthening in people with Sport-related Concussion and Brain Concussion, run by University of Michigan at 1 site in United States.
Trial summary
Sport-related concussion is a common and serious injury that can affect athletes of all ages in any sport. The purpose of this project is to study the effect of a 12-week manual resistance neck strengthening exercise program on participants' neck size and strength and how their heads and necks move during simulated… Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Sport-related Concussion, Brain Concussion, Healthy
- What is being tested?
- high-intensity neck strengthening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2021to 10 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Provision of signed and dated informed consent form, or assent form with parental consent for minors
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Participated in a soccer team, club, or other soccer program/organization within the preceding 2 years
- Be willing to adhere to the assigned exercise regimen
Who cannot join
- Prior history of trauma-induced neck injury of sufficient severity to require treatment by a medical provider within 30 days of injury or to limit sport participation for > 1 day (note: having received routine chiropractic treatment in the absence of a recent traumatic injury to the neck will not be considered to meet this criterion)
- Any prior history of whiplash injury, stinger/burner, or cervical radiculopathy diagnosed by a medical provider
- Any prior history of bone, disk, neural, or ligamentous abnormality identified on cervical spine medical imaging performed for any reason that is felt by the PI (or designee) to present a risk to study participation
- Any prior history of surgery involving the cervical spine (note: having undergone non-spine surgery to the soft tissue structures in the neck will not necessarily exclude participation, but will be considered on a case-by-case basis by the PI, or his designee, with consultation from the performing surgeon when deemed appropriate)
- Self-report of moderate or severe neck pain (rated as 5 or greater on a 10-point pain scale) lasting > 1 day in the previous 6 months that required any evaluation or treatment by a medical provider or that limited sport participation for > 1 day (note: having received routine chiropractic treatment in the absence of moderate-severe neck pain will not be considered to meet this criterion)
- Self-report of low back pain (any severity) associated with morning stiffness occurring 30 days or more in the previous 3 months.
Show all 19Show fewer
- Prior episode(s) of unexplained upper extremity numbness, tingling, or weakness suspicious to the PI, or designee, for a stinger/burner or cervical radiculopathy in the last 3 years
- Prior history of concussion in the previous 6 months diagnosed by a medical provider or suspected by the subject, or the parent/guardian of a minor (if no medical evaluation was sought), or any diagnosed/suspected concussion without full recovery and clearance to resume unrestricted sport participation.
- Personal history of migraine headaches within the previous 3 years diagnosed by a medical provider, with one or more headache episodes, or requiring treatment.
- Personal history of anxiety disorder diagnosed by a medical provider that has either been difficult to control, affected daily function, or required treatment with medication or counseling within the previous 3 years.
- Parental/guardian known history of anxiety disorder diagnosed by a medical provider that has either been difficult to control, affected daily function, or required treatment with medication or counseling within the previous 3 years.
- Prior personal of any of the following or known family history of the following medical conditions known to be associated with atlanto-axial instability diagnosed by a medical provider: parental history of Down Syndrome, Ehlers-Danlos Syndrome, or Marfan syndrome; parental, or sibling history of rheumatoid arthritis/other systemic inflammatory disease with joint involvement or mucopolysaccharidosis
- Known exposure to or infection with head lice in the previous 30 days
- Known or suspected pregnancy (for females)
- Serious allergic reaction to nickel/metal jewelry
- Any contraindication to MRI scanning
- Presence of significant abnormality on a standardized screening neurological and musculoskeletal physical examination
- Prior participation in a resistance exercise training program including exercises specifically intended to target the neck muscles within 3 months of enrollment, or intention to begin participating in such an exercise program outside of the study protocol during the upcoming 12-week study period
- Unable to speak and understand English
Trial locations and contacts
1 site in 1 country.
About this study
Sport-related concussion is a common and serious injury that can affect athletes of all ages in any sport. The purpose of this project is to study the effect of a 12-week manual resistance neck strengthening exercise program on participants' neck size and strength and how their heads and necks move during simulated sport-associated tasks. This study will help determine if greater neck strength may lower an athlete's risk of sport-related concussion. Each healthy male and female soccer athlete between the ages of 13-19 enrolled in the study will participate for approximately four months. Study participation includes routine visits with various assessments (i.e. certain body measurements, magnetic resonance imaging, ultrasound) in addition to the strengthening exercise program.
Read the detailed description
This study was updated to remove the low-volume group and the amendment was approved 3/29/2023 at the Institutional Review Board. This change to remove the low-volume exercise group was due to reduced enrollment numbers following the Corona Virus Disease (COVID) Pandemic.
- Conditions
- Sport-related Concussion, Brain Concussion, Healthy
- Being tested
- high-intensity neck strengthening, Control group
- Keywords
- Concussion, Contact sport, Collision sport, Neck strengthening, Soccer, Head Acceleration
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-intensity neck strengtheningOther
All subjects will exercise 2 days per week for 12 weeks under the direct supervision of a study-assigned strength coach with a minimum of 1 day of rest between exercise sessions.
Participants will perform a standardized set of general resistance exercises targeting the chest, shoulders, back, upper and lower extremities, and core. Additionally, they will also perform a higher number of repetitions of manual resistance neck strengthening exercises in sagittal plane flexion and extension, coronal plane lateral flexion in both directions, and axial plane rotation in both directions,as well as dumbbell shoulder shrugs.
Control groupOther
All subjects will exercise 2 days per week for 12 weeks under the direct supervision of a study-assigned strength coach with a minimum of 1 day of rest between exercise sessions.
Participants will perform a standardized set of general resistance exercises targeting only the chest, shoulders, back, upper and lower extremities, and core, without resistance exercises specifically targeting the neck.
| Study group | Role | What they receive |
|---|---|---|
| high-intensity neck strengthening group | Experimental | Not described Receives: Other: high-intensity neck strengthening |
| Control group | Other | Not described Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Linear Motion.
The linear component of head acceleration was measured with a sensor attached to the head, while a device applied force to the head. The data is reported where higher values represent greater acceleration per amount of force delivered (zero represents no acceleration and greater numbers higher acceleration).
Measured: 4 weeks, 8 weeks, 12 weeks
Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Angular Motion.
The angular component of head acceleration was measured with a sensor attached to the head, while a device applied force to the head. The data is reported where higher values represent greater acceleration per amount of force delivered (zero represents no acceleration and greater numbers higher acceleration).
Measured: 4 weeks, 8 weeks, 12 weeks
Secondary outcomes (2)
Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Linear Motion.
The linear component of head acceleration was measured with a sensor attached to the head, while a simulated body check was administered. The data is reported where higher values represent greater acceleration (zero represents no acceleration and greater numbers higher acceleration).
Measured: 4 weeks, 8 weeks, 12 weeks
Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Angular Motion.
The angular component of head acceleration was measured with a sensor attached to the head, while a simulated body check was administered. The data is reported where higher values represent greater acceleration (zero represents no acceleration and greater numbers higher acceleration).
Measured: 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start22 Jan 2021
- Primary completion8 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sport-related ConcussionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, James Eckner, University of Michigan
- Investigators
- James T Eckner, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883165
- Sponsor's protocol ID
- HUM00152807
- Other IDs
- 1R01HD093733-01A1
- Status last verified
- Jun 2025
- First submitted
- 18 Mar 2019
- Last updated
- 24 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eckner JT, Goshtasbi A, Curtis K, Kapshai A, Myyra E, Franco LM, Favre M, Jacobson JA, Ashton-Miller JA. Feasibility and Effect of Cervical Resistance Training on Head Kinematics in Youth Athletes: A Pilot Study. Am J Phys Med Rehabil. 2018 Apr;97(4):292-297. doi: 10.1097/PHM.0000000000000843.
PubMed 29557889Eckner JT, Oh YK, Joshi MS, Richardson JK, Ashton-Miller JA. Effect of neck muscle strength and anticipatory cervical muscle activation on the kinematic response of the head to impulsive loads. Am J Sports Med. 2014 Mar;42(3):566-76. doi: 10.1177/0363546513517869. Epub 2014 Jan 31.
PubMed 24488820
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How do the Neck Muscles Influence Head Acceleration During Sport-associated Impact Events in High School Athletes?
- ClinicalTrials.gov ID
- NCT03883165
- Acronym / sponsor ID
- HUM00152807
- Conditions
- Sport-related Concussion, Brain Concussion, Healthy
- Keywords
- Concussion, Contact sport, Collision sport, Neck strengthening, Soccer, Head Acceleration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 8 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Posted 24 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sport-related concussion is a common and serious injury that can affect athletes of all ages in any sport. The purpose of this project is to study the effect of a 12-week manual resistance neck strengthening exercise program on participants' neck size and strength and how their heads and necks move during simulated sport-associated tasks. This study will help determine if greater neck strength may lower an athlete's risk of sport-related concussion. Each healthy male and female soccer athlete between the ages of 13-19 enrolled in the study will participate for approximately four months. Study participation includes routine visits with various assessments (i.e. certain body measurements, magnetic resonance imaging, ultrasound) in addition to the strengthening exercise program.
Detailed description
This study was updated to remove the low-volume group and the amendment was approved 3/29/2023 at the Institutional Review Board. This change to remove the low-volume exercise group was due to reduced enrollment numbers following the Corona Virus Disease (COVID) Pandemic.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-intensity neck strengthening group | Experimental | Other: high-intensity neck strengthening |
| Control group | Other | Other: Control group |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Provision of signed and dated informed consent form, or assent form with parental consent for minors
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Participated in a soccer team, club, or other soccer program/organization within the preceding 2 years
- Be willing to adhere to the assigned exercise regimen
Key exclusion criteria (19 listed)
- Prior history of trauma-induced neck injury of sufficient severity to require treatment by a medical provider within 30 days of injury or to limit sport participation for > 1 day (note: having received routine chiropractic treatment in the absence of a recent traumatic injury to the neck will not be considered to meet this criterion)
- Any prior history of whiplash injury, stinger/burner, or cervical radiculopathy diagnosed by a medical provider
- Any prior history of bone, disk, neural, or ligamentous abnormality identified on cervical spine medical imaging performed for any reason that is felt by the PI (or designee) to present a risk to study participation
- Any prior history of surgery involving the cervical spine (note: having undergone non-spine surgery to the soft tissue structures in the neck will not necessarily exclude participation, but will be considered on a case-by-case basis by the PI, or his designee, with consultation from the performing surgeon when deemed appropriate)
- Self-report of moderate or severe neck pain (rated as 5 or greater on a 10-point pain scale) lasting > 1 day in the previous 6 months that required any evaluation or treatment by a medical provider or that limited sport participation for > 1 day (note: having received routine chiropractic treatment in the absence of moderate-severe neck pain will not be considered to meet this criterion)
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 |
|---|---|---|
| high-intensity neck strengtheningAll subjects will exercise 2 days per week for 12 weeks under the direct supervision of a study-assigned strength coach with a minimum of 1 day of rest between exercise sessions. Participants will perform a standardized set of general resistance exercises targeting the chest, shoulders, back, upper and lower extremities, and core. Additionally, they will also perform a higher number of repetitions of manual resistance neck strengthening exercises in sagittal plane flexion and extension, coronal plane lateral flexion in both directions, and axial plane rotation in both directions,as well as dumbbell shoulder shrugs. | Other | high-intensity neck strengthening group |
| Control groupAll subjects will exercise 2 days per week for 12 weeks under the direct supervision of a study-assigned strength coach with a minimum of 1 day of rest between exercise sessions. Participants will perform a standardized set of general resistance exercises targeting only the chest, shoulders, back, upper and lower extremities, and core, without resistance exercises specifically targeting the neck. | Other | Control group |
Primary outcome
Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Linear Motion.
Time frame: 4 weeks, 8 weeks, 12 weeks
The linear component of head acceleration was measured with a sensor attached to the head, while a device applied force to the head. The data is reported where higher values represent greater acceleration per amount of force delivered (zero represents no acceleration and greater numbers higher acceleration).
Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Angular Motion.
Time frame: 4 weeks, 8 weeks, 12 weeks
The angular component of head acceleration was measured with a sensor attached to the head, while a device applied force to the head. The data is reported where higher values represent greater acceleration per amount of force delivered (zero represents no acceleration and greater numbers higher acceleration).
2 secondary outcomes
Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Linear Motion.
Time frame: 4 weeks, 8 weeks, 12 weeks
Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Angular Motion.
Time frame: 4 weeks, 8 weeks, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29557889Eckner JT, Goshtasbi A, Curtis K, Kapshai A, Myyra E, Franco LM, Favre M, Jacobson JA, Ashton-Miller JA. Feasibility and Effect of Cervical Resistance Training on Head Kinematics in Youth Athletes: A Pilot Study. Am J Phys Med Rehabil. 2018 Apr;97(4):292-297. doi: 10.1097/PHM.0000000000000843.
- Background: PubMed 24488820Eckner JT, Oh YK, Joshi MS, Richardson JK, Ashton-Miller JA. Effect of neck muscle strength and anticipatory cervical muscle activation on the kinematic response of the head to impulsive loads. Am J Sports Med. 2014 Mar;42(3):566-76. doi: 10.1177/0363546513517869. Epub 2014 Jan 31.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
James T Eckner, MD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-intensity neck strengthening in people with Sport-related Concussion and Brain Concussion, run by University of Michigan 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 19 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 24 Jun 2025. 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. 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?
Yes. Results are posted in the registry (first posted 24 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Linear Motion. (time frame: 4 weeks, 8 weeks, 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03883165, which also lists 2 linked publications.
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 24 Jun 2025.