Back to resultsNeck Strengthening Program for the Prevention or Mitigation of Sports Concussion (PCONS)
Primary Purpose
Concussion, Brain
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neck strengthening exercise to prevent concussion
Sponsored by
About this trial
This is an interventional prevention trial for Concussion, Brain focused on measuring concussion, football, student, athlete, sports
Eligibility Criteria
Inclusion Criteria:
- Involved in programmatic athletic activities with an ongoing duration of at least 4 weeks.
- Written informed consent obtained by the subject or subject's legal guardian.
- Written assent from subjects ages 8 years old and above
- Subject is between the ages of 5 and 22 years, male or female.
- Subjects from all racial and ethnic origins will have an opportunity to participate.
Exclusion Criteria:
- Corrected vision less than 20/500.
Sites / Locations
- Hennepin County Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise arm
Arm Description
This arm will perform twice weekly neck strengthening exercises.
Outcomes
Primary Outcome Measures
Effect of increase in neck strength in reducing risk of concussion
Neck strength, as measured by a dynamometer, will be assessed and compared to baseline. Magnitude in strength will be analyzed in relation to incidence, severity, and duration of concussion.
Secondary Outcome Measures
Effect of baseline neck strength on risk of concussion
Risk of concussion will be analyzed in relation to baseline strength measurements to assess overall effect of neck strength.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03237468
Brief Title
Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion
Acronym
PCONS
Official Title
Effectiveness of a Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion Injuries in Student Athletes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 11, 2017 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CentraCare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study looks to determine effectiveness of neck strengthening to reduce the incident, duration, and severity of sports related concussion in student athletes.
Detailed Description
After recruitment, subjects will have neck strength measured as baseline in addition to doing SCAT5 for baseline and eye tracking, funding pending, in order to compare later assessment for concussion. Throughout study, subject will perform basic, unweighted and weighted neck strengthening exercises twice a week. Periodic re evaluations of neck strength will be performed in order to determine progress. Any time a subject incurs a sports related concussion, a SCAT5 assessment, and eye tracking funding pending, will be done and compared to baseline to measure severity of injury. Weekly follow ups will be done to assess duration of concussion. All measurements, assessments, and exercises are non-invasive and provide minimal risk to subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Brain
Keywords
concussion, football, student, athlete, sports
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise arm
Arm Type
Experimental
Arm Description
This arm will perform twice weekly neck strengthening exercises.
Intervention Type
Other
Intervention Name(s)
Neck strengthening exercise to prevent concussion
Intervention Description
Neck strengthening exercise to prevent concussion in student athletes.
Primary Outcome Measure Information:
Title
Effect of increase in neck strength in reducing risk of concussion
Description
Neck strength, as measured by a dynamometer, will be assessed and compared to baseline. Magnitude in strength will be analyzed in relation to incidence, severity, and duration of concussion.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Effect of baseline neck strength on risk of concussion
Description
Risk of concussion will be analyzed in relation to baseline strength measurements to assess overall effect of neck strength.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Involved in programmatic athletic activities with an ongoing duration of at least 4 weeks.
Written informed consent obtained by the subject or subject's legal guardian.
Written assent from subjects ages 8 years old and above
Subject is between the ages of 5 and 22 years, male or female.
Subjects from all racial and ethnic origins will have an opportunity to participate.
Exclusion Criteria:
- Corrected vision less than 20/500.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uzma Samadani, MD, PhD
Organizational Affiliation
Hennepin County Medical Center, Minneapolis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
12. IPD Sharing Statement
Citations:
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
PubMed Identifier
25282771
Citation
Dugan S, Seymour L, Roesler J, Glover L, Kinde M. This is your brain on sports. Measuring concussions in high school athletes in the Twin Cities metropolitan area. Minn Med. 2014 Sep;97(9):43-6.
Results Reference
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PubMed Identifier
23439331
Citation
Hildenbrand KJ, Vasavada AN. Collegiate and high school athlete neck strength in neutral and rotated postures. J Strength Cond Res. 2013 Nov;27(11):3173-82. doi: 10.1519/JSC.0b013e31828a1fe2.
Results Reference
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PubMed Identifier
22050943
Citation
Daneshvar DH, Riley DO, Nowinski CJ, McKee AC, Stern RA, Cantu RC. Long-term consequences: effects on normal development profile after concussion. Phys Med Rehabil Clin N Am. 2011 Nov;22(4):683-700, ix. doi: 10.1016/j.pmr.2011.08.009. Epub 2011 Sep 23.
Results Reference
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PubMed Identifier
24930131
Citation
Collins CL, Fletcher EN, Fields SK, Kluchurosky L, Rohrkemper MK, Comstock RD, Cantu RC. Neck strength: a protective factor reducing risk for concussion in high school sports. J Prim Prev. 2014 Oct;35(5):309-19. doi: 10.1007/s10935-014-0355-2.
Results Reference
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PubMed Identifier
24091298
Citation
Gutierrez GM, Conte C, Lightbourne K. The relationship between impact force, neck strength, and neurocognitive performance in soccer heading in adolescent females. Pediatr Exerc Sci. 2014 Feb;26(1):33-40. doi: 10.1123/pes.2013-0102. Epub 2013 Oct 2.
Results Reference
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Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion
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