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How do the Neck Muscles Influence Head Acceleration During Sport-associated Impact Events in High School Athletes?

Primary Purpose

Sport-related Concussion, Brain Concussion, Healthy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
high-intensity neck strengthening
Control group
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sport-related Concussion focused on measuring Concussion, Contact sport, Collision sport, Neck strengthening, Soccer, Head Acceleration

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Michigan MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

high-intensity neck strengthening group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Mean area under the net head acceleration vs. time curve during direct loading, with anticipatory bracing.

Secondary Outcome Measures

Mean area under the net head acceleration vs. time curve during indirect loading, with anticipatory bracing.

Full Information

First Posted
March 18, 2019
Last Updated
April 10, 2023
Sponsor
University of Michigan
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03883165
Brief Title
How do the Neck Muscles Influence Head Acceleration During Sport-associated Impact Events in High School Athletes?
Official Title
How do the Neck Muscles Influence Head Acceleration During Sport-associated Impact Events in High School Athletes?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 COVID.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sport-related Concussion, Brain Concussion, Healthy
Keywords
Concussion, Contact sport, Collision sport, Neck strengthening, Soccer, Head Acceleration

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
high-intensity neck strengthening group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
high-intensity neck strengthening
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean area under the net head acceleration vs. time curve during direct loading, with anticipatory bracing.
Time Frame
12 weeks post therapy (assessment 4)
Secondary Outcome Measure Information:
Title
Mean area under the net head acceleration vs. time curve during indirect loading, with anticipatory bracing.
Time Frame
12 weeks post therapy (assessment 4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Farkas, MS
Phone
734-936-7704
Email
danfar@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James T Eckner, MD, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Farkas, MS
Phone
734-936-7704
Email
DanFar@umich.edu
First Name & Middle Initial & Last Name & Degree
James T Eckner, MD, MS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29557889
Citation
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.
Results Reference
background
PubMed Identifier
24488820
Citation
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.
Results Reference
background
Links:
URL
https://journals.lww.com/ajpmr/Fulltext/2018/04000/Feasibility_and_Effect_of_Cervical_Resistance.10.aspx
Description
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How do the Neck Muscles Influence Head Acceleration During Sport-associated Impact Events in High School Athletes?

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