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

C

CentraCare

Status

Unknown

Conditions

Concussion, Brain

Treatments

Other: Neck strengthening exercise to prevent concussion

Study type

Interventional

Funder types

Other

Identifiers

NCT03237468
HSR#17-4360

Details and patient eligibility

About

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

Full 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.

Enrollment

1,500 estimated patients

Sex

All

Ages

12 to 22 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,500 participants in 1 patient group

Exercise arm
Experimental group
Description:
This arm will perform twice weekly neck strengthening exercises.
Treatment:
Other: Neck strengthening exercise to prevent concussion

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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