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

February 2, 2021 updated by: CentraCare

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of baseline neck strength on risk of concussion
Time Frame: One year
Risk of concussion will be analyzed in relation to baseline strength measurements to assess overall effect of neck strength.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CentraCare

Investigators

  • Principal Investigator: Uzma Samadani, MD, PHD, Hennepin County Medical Center, Minneapolis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2017

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

July 26, 2017

First Submitted That Met QC Criteria

July 31, 2017

First Posted (Actual)

August 2, 2017

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSR#17-4360

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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