- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03883165
How do the Neck Muscles Influence Head Acceleration During Sport-associated Impact Events in High School Athletes?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Daniel Farkas, MS
- Phone Number: 734-936-7704
- Email: DanFar@umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48108
- Recruiting
- Michigan Medicine
-
Contact:
- Daniel Farkas, MS
- Phone Number: 734-936-7704
- Email: DanFar@umich.edu
-
Principal Investigator:
- James T Eckner, MD, MS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Control group
|
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. |
Experimental: high-intensity neck strengthening group
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean area under the net head acceleration vs. time curve during direct loading, with anticipatory bracing.
Time Frame: 12 weeks post therapy (assessment 4)
|
12 weeks post therapy (assessment 4)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean area under the net head acceleration vs. time curve during indirect loading, with anticipatory bracing.
Time Frame: 12 weeks post therapy (assessment 4)
|
12 weeks post therapy (assessment 4)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: James T Eckner, MD, MS, University of Michigan
Publications and helpful links
General Publications
- Eckner 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00152807
- 1R01HD093733-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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