NCT03237468

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

August 11, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

3.8 years

First QC Date

July 26, 2017

Last Update Submit

February 2, 2021

Conditions

Concussion, Brain

Keywords

concussionfootballstudentathletesports

Outcome Measures

Primary Outcomes (1)

  • Effect of increase in neck strength in reducing risk of concussion

    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.

    One year

Secondary Outcomes (1)

  • Effect of baseline neck strength on risk of concussion

    One year

Study Arms (1)

Exercise arm

EXPERIMENTAL

This arm will perform twice weekly neck strengthening exercises.

Other: Neck strengthening exercise to prevent concussion

Interventions

Neck strengthening exercise to prevent concussionOTHER

Neck strengthening exercise to prevent concussion in student athletes.

Exercise arm

Eligibility Criteria

Age12 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \- Corrected vision less than 20/500.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (6)

  • 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.

    PMID: 24488820BACKGROUND

  • 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.

    PMID: 25282771BACKGROUND

  • 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.

    PMID: 23439331BACKGROUND

  • 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.

    PMID: 22050943BACKGROUND

  • 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.

    PMID: 24930131BACKGROUND

  • 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.

    PMID: 24091298BACKGROUND

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Uzma Samadani, MD, PhD

    Hennepin County Medical Center, Minneapolis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2017

First Posted

August 2, 2017

Study Start

August 11, 2017

Primary Completion

June 1, 2021

Study Completion

July 1, 2022

Last Updated

February 3, 2021

Record last verified: 2021-02

Locations

US(1)