We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    effectiveness of a neck strengthening program | Minnesota, United States
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03237468
Recruitment Status : Unknown
Verified February 2021 by CentraCare.
Recruitment status was:  Active, not recruiting
First Posted : August 2, 2017
Last Update Posted : February 3, 2021
Information provided by (Responsible Party):

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 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 11, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2022

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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   12 Years to 22 Years   (Child, Adult)
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.

Exclusion Criteria:

- Corrected vision less than 20/500.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237468

Layout table for location information
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Layout table for investigator information
Principal Investigator: Uzma Samadani, MD, PhD Hennepin County Medical Center, Minneapolis
  Study Documents (Full-Text)

Documents provided by CentraCare:
Study Protocol  [PDF] July 12, 2017

Layout table for additonal information
Responsible Party: CentraCare
ClinicalTrials.gov Identifier: NCT03237468    
Other Study ID Numbers: HSR#17-4360
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CentraCare:
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Concussion
Brain Injuries, Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating