Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion

NCT ID: NCT03237468

Last Updated: 2021-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-11

Study Completion Date

2022-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Concussion, Brain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Exercise arm

This arm will perform twice weekly neck strengthening exercises.

Group Type EXPERIMENTAL

Neck strengthening exercise to prevent concussion

Intervention Type OTHER

Neck strengthening exercise to prevent concussion in student athletes.

Interventions

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Neck strengthening exercise to prevent concussion

Neck strengthening exercise to prevent concussion in student athletes.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CentraCare

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Uzma Samadani, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hennepin County Medical Center, Minneapolis

Locations

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Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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Eckner JT, Oh YK, Joshi MS, Richardson JK, Ashton-Miller JA. Effect of neck muscle strength and anticipatory cervical muscle activation on the kinematic response of the head to impulsive loads. Am J Sports Med. 2014 Mar;42(3):566-76. doi: 10.1177/0363546513517869. Epub 2014 Jan 31.

Reference Type BACKGROUND
PMID: 24488820 (View on PubMed)

Dugan S, Seymour L, Roesler J, Glover L, Kinde M. This is your brain on sports. Measuring concussions in high school athletes in the Twin Cities metropolitan area. Minn Med. 2014 Sep;97(9):43-6.

Reference Type BACKGROUND
PMID: 25282771 (View on PubMed)

Hildenbrand KJ, Vasavada AN. Collegiate and high school athlete neck strength in neutral and rotated postures. J Strength Cond Res. 2013 Nov;27(11):3173-82. doi: 10.1519/JSC.0b013e31828a1fe2.

Reference Type BACKGROUND
PMID: 23439331 (View on PubMed)

Daneshvar DH, Riley DO, Nowinski CJ, McKee AC, Stern RA, Cantu RC. Long-term consequences: effects on normal development profile after concussion. Phys Med Rehabil Clin N Am. 2011 Nov;22(4):683-700, ix. doi: 10.1016/j.pmr.2011.08.009. Epub 2011 Sep 23.

Reference Type BACKGROUND
PMID: 22050943 (View on PubMed)

Collins CL, Fletcher EN, Fields SK, Kluchurosky L, Rohrkemper MK, Comstock RD, Cantu RC. Neck strength: a protective factor reducing risk for concussion in high school sports. J Prim Prev. 2014 Oct;35(5):309-19. doi: 10.1007/s10935-014-0355-2.

Reference Type BACKGROUND
PMID: 24930131 (View on PubMed)

Gutierrez GM, Conte C, Lightbourne K. The relationship between impact force, neck strength, and neurocognitive performance in soccer heading in adolescent females. Pediatr Exerc Sci. 2014 Feb;26(1):33-40. doi: 10.1123/pes.2013-0102. Epub 2013 Oct 2.

Reference Type BACKGROUND
PMID: 24091298 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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HSR#17-4360

Identifier Type: -

Identifier Source: org_study_id

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