Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion

Concussion, Brain Clinical Trial

— PCONS  

Official title:

Effectiveness of a Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion Injuries in Student Athletes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03237468
• Other study ID #: HSR#17-4360
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 11, 2017
• Est. completion date: July 2022

Study information

• Verified date: February 2021
• Source: CentraCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study looks to determine effectiveness of neck strengthening to reduce the incident, duration, and severity of sports related concussion in student athletes.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: July 2022
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Brain

Intervention

Other:
• Neck strengthening exercise to prevent concussion
Neck strengthening exercise to prevent concussion in student athletes.

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
CentraCare

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year
Secondary	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.	One year