Back to resultsEvaluation of a Neck Strengthening Program to Reduce the Risk of Sport-related Concussion
Primary Purpose
Sport-related Concussion, Brain Concussion, Healthy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neck Strengthening
Sponsored by
About this trial
This is an interventional other trial for Sport-related Concussion focused on measuring Concussion, Contact sport, Collision sport, Neck strengthening
Eligibility Criteria
Inclusion Criteria:
- Contact/collision sport athletes (for example, american football, soccer, rugby, lacrosse, ice hockey, field hockey, basketball, wrestling, boxing, martial arts, water polo)
Exclusion Criteria:
- History of concussion (suspected or diagnosed) in the previous 6 months
- History of neck pain or injury in the previous 6 months
- History of migraine headaches
- History of personal or parental history of a diagnosed anxiety disorder
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Body Strengthening (Only)
Body Strengthening + Neck Strengthening
Arm Description
All participants will complete a general resistance exercise training program.
Participants assigned to the neck strengthening group will complete additional supervised exercises specifically designed to strengthen the neck.
Outcomes
Primary Outcome Measures
Head linear velocity
Head angular velocity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02455037
Brief Title
Evaluation of a Neck Strengthening Program to Reduce the Risk of Sport-related Concussion
Official Title
Evaluation of a Neck Strengthening Program as a Potential Intervention to Reduce the Risk of Sport-related Concussion
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of a neck strengthening program as a potential intervention to reduce the risk of sport-related concussion in youth contact and collision sport athletes.
Detailed Description
This is a pilot study to investigate the effect of a supervised 8 week strengthening intervention in male and female youth contact and collision sport athletes. Participants will complete a supervised strengthening exercise intervention involving manual resistance exercises administered by a strength coach with pre- and post-intervention assessments of neck size and strength.
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
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Body Strengthening (Only)
Arm Type
No Intervention
Arm Description
All participants will complete a general resistance exercise training program.
Arm Title
Body Strengthening + Neck Strengthening
Arm Type
Experimental
Arm Description
Participants assigned to the neck strengthening group will complete additional supervised exercises specifically designed to strengthen the neck.
Intervention Type
Other
Intervention Name(s)
Neck Strengthening
Intervention Description
Targeted neck strengthening exercises
Primary Outcome Measure Information:
Title
Head linear velocity
Time Frame
Change from baseline to end of 8 week intervention.
Title
Head angular velocity
Time Frame
Change from baseline to end of 8 week intervention.
Other Pre-specified Outcome Measures:
Title
Neck size (girth and muscle cross-sectional area)
Time Frame
Change from baseline to end of 8 week intervention.
Title
Neck strength (maximum force generating capacity)
Time Frame
Change from baseline to end of 8 week intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Contact/collision sport athletes (for example, american football, soccer, rugby, lacrosse, ice hockey, field hockey, basketball, wrestling, boxing, martial arts, water polo)
Exclusion Criteria:
History of concussion (suspected or diagnosed) in the previous 6 months
History of neck pain or injury in the previous 6 months
History of migraine headaches
History of personal or parental history of a diagnosed anxiety disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James T Eckner, MD, MS
Organizational Affiliation
Assistant Professor, Department of Physical Medicine & Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
2263964
Citation
Ashton-Miller JA, McGlashen KM, Herzenberg JE, Stohler CS. Cervical muscle myoelectric response to acute experimental sternocleidomastoid pain. Spine (Phila Pa 1976). 1990 Oct;15(10):1006-12. doi: 10.1097/00007632-199015100-00005.
Results Reference
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PubMed Identifier
17657206
Citation
Centers for Disease Control and Prevention (CDC). Nonfatal traumatic brain injuries from sports and recreation activities--United States, 2001-2005. MMWR Morb Mortal Wkly Rep. 2007 Jul 27;56(29):733-7.
Results Reference
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PubMed Identifier
18804002
Citation
Dvir Z, Prushansky T. Cervical muscles strength testing: methods and clinical implications. J Manipulative Physiol Ther. 2008 Sep;31(7):518-24. doi: 10.1016/j.jmpt.2008.08.008.
Results Reference
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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
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PubMed Identifier
19593415
Citation
Broglio SP, Sosnoff JJ, Shin S, He X, Alcaraz C, Zimmerman J. Head impacts during high school football: a biomechanical assessment. J Athl Train. 2009 Jul-Aug;44(4):342-9. doi: 10.4085/1062-6050-44.4.342.
Results Reference
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PubMed Identifier
19433425
Citation
Dick RW. Is there a gender difference in concussion incidence and outcomes? Br J Sports Med. 2009 May;43 Suppl 1:i46-50. doi: 10.1136/bjsm.2009.058172.
Results Reference
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PubMed Identifier
11880811
Citation
Garces GL, Medina D, Milutinovic L, Garavote P, Guerado E. Normative database of isometric cervical strength in a healthy population. Med Sci Sports Exerc. 2002 Mar;34(3):464-70. doi: 10.1097/00005768-200203000-00013.
Results Reference
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PubMed Identifier
21088602
Citation
Guskiewicz KM, Mihalik JP. Biomechanics of sport concussion: quest for the elusive injury threshold. Exerc Sport Sci Rev. 2011 Jan;39(1):4-11. doi: 10.1097/JES.0b013e318201f53e.
Results Reference
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PubMed Identifier
23610685
Citation
Hamilton DF, Gatherer D, Jenkins PJ, Maclean JG, Hutchison JD, Nutton RW, Simpson AH. Age-related differences in the neck strength of adolescent rugby players: A cross-sectional cohort study of Scottish schoolchildren. Bone Joint Res. 2012 Jul 1;1(7):152-7. doi: 10.1302/2046-3758.17.2000079. Print 2012 Jul.
Results Reference
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Evaluation of a Neck Strengthening Program to Reduce the Risk of Sport-related Concussion
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