Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion

Not Applicable

• Conditions: Concussion, Brain
• Interventions: Other: Neck strengthening exercise to prevent concussion

• Registration Number: NCT03237468
• Lead Sponsor: CentraCare

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.

Study Timeline

• Study First Submitted: 2017-07-26
• Study First Submitted QC: 2017-07-31
• Study First Posted: 2017-08-02
• Study Start: 2017-08-11
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03
• Primary Completion: 2021-06
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise arm	Neck strengthening exercise to prevent concussion	This arm will perform twice weekly neck strengthening exercises.

Primary Outcome Measures

Name	Time	Method
Effect of increase in neck strength in reducing risk of concussion	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 Outcome Measures

Name	Time	Method
Effect of baseline neck strength on risk of concussion	One year	Risk of concussion will be analyzed in relation to baseline strength measurements to assess overall effect of neck strength.

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States