How do the Neck Muscles Influence Head Acceleration During Sport-associated Impact Events in High School Athletes?
2 other identifiers
interventional
48
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2019
CompletedFirst Posted
Study publicly available on registry
March 20, 2019
CompletedStudy Start
First participant enrolled
January 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2024
CompletedResults Posted
Study results publicly available
June 24, 2025
CompletedJune 24, 2025
June 1, 2025
3.4 years
March 18, 2019
May 29, 2025
June 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
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).
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.
4 weeks, 8 weeks, 12 weeks
Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Angular Motion.
4 weeks, 8 weeks, 12 weeks
Study Arms (2)
high-intensity neck strengthening group
EXPERIMENTALControl group
OTHERInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Michigan Medicine
Ann Arbor, Michigan, 48108, United States
Related Publications (2)
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.
PMID: 29557889BACKGROUNDEckner 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.
PMID: 24488820BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- James T Eckner, MD, MS
- Organization
- University of Michigan Medical School
Study Officials
- PRINCIPAL INVESTIGATOR
James T Eckner, MD, MS
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Neither subjects nor the study team members responsible for performing the laboratory- or radiology-based assessment will be informed of group allocation status, although subjects will be aware of whether or not they are performing neck strengthening exercises during their exercise sessions. Subjects will be instructed not to reveal their group status during subsequent assessment sessions.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Physical Medicine and Rehabilitation
Study Record Dates
First Submitted
March 18, 2019
First Posted
March 20, 2019
Study Start
January 22, 2021
Primary Completion
June 8, 2024
Study Completion
June 10, 2024
Last Updated
June 24, 2025
Results First Posted
June 24, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share