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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

July 26, 2017
August 2, 2017
September 14, 2017
August 11, 2017
August 30, 2018   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03237468 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion
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.
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.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Concussion, Brain
Other: Neck strengthening exercise to prevent concussion
Neck strengthening exercise to prevent concussion in student athletes.
Experimental: Exercise arm
This arm will perform twice weekly neck strengthening exercises.
Intervention: Other: Neck strengthening exercise to prevent concussion

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
Same as current
December 30, 2018
August 30, 2018   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
12 Years to 22 Years   (Child, Adult)
Yes
Contact: Uzma Samadani, MD, PhD 6128737190 uzma.samadani@hcmed.org
Contact: Joseph Toninato, BS 2183415822 joseph.toninato@hcmed.org
United States
 
 
NCT03237468
HSR#17-4360
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Minneapolis Medical Research Foundation
Minneapolis Medical Research Foundation
Not Provided
Principal Investigator: Uzma Samadani, MD, PhD Hennepin County Medical Center, Minneapolis
Minneapolis Medical Research Foundation
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP