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Trial record 1 of 1 for:    effectiveness of a neck strengthening program | Minnesota, United States
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Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion (PCONS)

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ClinicalTrials.gov Identifier: NCT03237468
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
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 : August 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



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Ages Eligible for Study:   12 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


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


Contacts
Contact: Uzma Samadani, MD, PhD 6128737190 uzma.samadani@hcmed.org
Contact: Joseph Toninato, BS 2183415822 joseph.toninato@hcmed.org

Locations
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Casey Byron, BS, MPT    612-760-0288    casey.byron@hcmed.org   
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Minneapolis Medical Research Foundation
Investigators
Principal Investigator: Uzma Samadani, MD, PhD Hennepin County Medical Center, Minneapolis
  Study Documents (Full-Text)

Documents provided by Minneapolis Medical Research Foundation:
Study Protocol  [PDF] July 12, 2017


Publications:
Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT03237468     History of Changes
Other Study ID Numbers: HSR#17-4360
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Minneapolis Medical Research Foundation:
concussion
football
student
athlete
sports

Additional relevant 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