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Clinical Trials/NCT03237468
NCT03237468
Unknown
Not Applicable

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

CentraCare1 site in 1 country1,500 target enrollmentAugust 11, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Concussion, Brain
Sponsor
CentraCare
Enrollment
1500
Locations
1
Primary Endpoint
Effect of increase in neck strength in reducing risk of concussion
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 11, 2017
End Date
July 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
CentraCare
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Effect of increase in neck strength in reducing risk of concussion

Time Frame: One year

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 Outcomes

  • Effect of baseline neck strength on risk of concussion(One year)

Study Sites (1)

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