PCONS: Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion

Sponsor

CentraCare (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03237468

Collaborator

(none)

1,500

Enrollment

Location

Arm

58.6

Anticipated Duration (Months)

25.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Concussion, Brain	Other: Neck strengthening exercise to prevent concussion	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1500 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 11, 2017

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise arm This arm will perform twice weekly neck strengthening exercises.	Other: Neck strengthening exercise to prevent concussion Neck strengthening exercise to prevent concussion in student athletes.

Arm

Intervention/Treatment

Experimental: Exercise arm

This arm will perform twice weekly neck strengthening exercises.

Other: Neck strengthening exercise to prevent concussion

Neck strengthening exercise to prevent concussion in student athletes.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 22 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.