NCT02455037

Brief Summary

Evaluation of a neck strengthening program as a potential intervention to reduce the risk of sport-related concussion in youth contact and collision sport athletes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

5 months

First QC Date

May 14, 2015

Last Update Submit

August 30, 2021

Conditions

Keywords

ConcussionContact sportCollision sportNeck strengthening

Outcome Measures

Primary Outcomes (2)

  • Head linear velocity

    Change from baseline to end of 8 week intervention.

  • Head angular velocity

    Change from baseline to end of 8 week intervention.

Other Outcomes (2)

  • Neck size (girth and muscle cross-sectional area)

    Change from baseline to end of 8 week intervention.

  • Neck strength (maximum force generating capacity)

    Change from baseline to end of 8 week intervention.

Study Arms (2)

Body Strengthening (Only)

NO INTERVENTION

All participants will complete a general resistance exercise training program.

Body Strengthening + Neck Strengthening

EXPERIMENTAL

Participants assigned to the neck strengthening group will complete additional supervised exercises specifically designed to strengthen the neck.

Other: Neck Strengthening

Interventions

Targeted neck strengthening exercises

Body Strengthening + Neck Strengthening

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Contact/collision sport athletes (for example, american football, soccer, rugby, lacrosse, ice hockey, field hockey, basketball, wrestling, boxing, martial arts, water polo)

You may not qualify if:

  • History of concussion (suspected or diagnosed) in the previous 6 months
  • History of neck pain or injury in the previous 6 months
  • History of migraine headaches
  • History of personal or parental history of a diagnosed anxiety disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48108, United States

Location

Related Publications (9)

  • Ashton-Miller JA, McGlashen KM, Herzenberg JE, Stohler CS. Cervical muscle myoelectric response to acute experimental sternocleidomastoid pain. Spine (Phila Pa 1976). 1990 Oct;15(10):1006-12. doi: 10.1097/00007632-199015100-00005.

    PMID: 2263964BACKGROUND
  • Centers for Disease Control and Prevention (CDC). Nonfatal traumatic brain injuries from sports and recreation activities--United States, 2001-2005. MMWR Morb Mortal Wkly Rep. 2007 Jul 27;56(29):733-7.

    PMID: 17657206BACKGROUND
  • Dvir Z, Prushansky T. Cervical muscles strength testing: methods and clinical implications. J Manipulative Physiol Ther. 2008 Sep;31(7):518-24. doi: 10.1016/j.jmpt.2008.08.008.

    PMID: 18804002BACKGROUND
  • 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
  • Broglio SP, Sosnoff JJ, Shin S, He X, Alcaraz C, Zimmerman J. Head impacts during high school football: a biomechanical assessment. J Athl Train. 2009 Jul-Aug;44(4):342-9. doi: 10.4085/1062-6050-44.4.342.

    PMID: 19593415BACKGROUND
  • Dick RW. Is there a gender difference in concussion incidence and outcomes? Br J Sports Med. 2009 May;43 Suppl 1:i46-50. doi: 10.1136/bjsm.2009.058172.

    PMID: 19433425BACKGROUND
  • Garces GL, Medina D, Milutinovic L, Garavote P, Guerado E. Normative database of isometric cervical strength in a healthy population. Med Sci Sports Exerc. 2002 Mar;34(3):464-70. doi: 10.1097/00005768-200203000-00013.

    PMID: 11880811BACKGROUND
  • Guskiewicz KM, Mihalik JP. Biomechanics of sport concussion: quest for the elusive injury threshold. Exerc Sport Sci Rev. 2011 Jan;39(1):4-11. doi: 10.1097/JES.0b013e318201f53e.

    PMID: 21088602BACKGROUND
  • Hamilton DF, Gatherer D, Jenkins PJ, Maclean JG, Hutchison JD, Nutton RW, Simpson AH. Age-related differences in the neck strength of adolescent rugby players: A cross-sectional cohort study of Scottish schoolchildren. Bone Joint Res. 2012 Jul 1;1(7):152-7. doi: 10.1302/2046-3758.17.2000079. Print 2012 Jul.

    PMID: 23610685BACKGROUND

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

  • James T Eckner, MD, MS

    Assistant Professor, Department of Physical Medicine & Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 14, 2015

First Posted

May 27, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

August 31, 2021

Record last verified: 2021-08

Locations