Evaluation of a Neck Strengthening Program to Reduce the Risk of Sport-related Concussion

August 30, 2021 updated by: James Eckner, University of Michigan

Evaluation of a Neck Strengthening Program as a Potential Intervention to Reduce the Risk of Sport-related Concussion

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a pilot study to investigate the effect of a supervised 8 week strengthening intervention in male and female youth contact and collision sport athletes. Participants will complete a supervised strengthening exercise intervention involving manual resistance exercises administered by a strength coach with pre- and post-intervention assessments of neck size and strength.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48108
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Body Strengthening (Only)
All participants will complete a general resistance exercise training program.
Experimental: Body Strengthening + Neck Strengthening
Participants assigned to the neck strengthening group will complete additional supervised exercises specifically designed to strengthen the neck.
Other: Neck Strengthening
Targeted neck strengthening exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Head linear velocity
Time Frame: Change from baseline to end of 8 week intervention.
Change from baseline to end of 8 week intervention.
Head angular velocity
Time Frame: Change from baseline to end of 8 week intervention.
Change from baseline to end of 8 week intervention.

Other Outcome Measures

Outcome Measure
Time Frame
Neck size (girth and muscle cross-sectional area)
Time Frame: Change from baseline to end of 8 week intervention.
Change from baseline to end of 8 week intervention.
Neck strength (maximum force generating capacity)
Time Frame: Change from baseline to end of 8 week intervention.
Change from baseline to end of 8 week intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: James T Eckner, MD, MS, Assistant Professor, Department of Physical Medicine & Rehabilitation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 14, 2015

First Submitted That Met QC Criteria

May 22, 2015

First Posted (Estimate)

May 27, 2015

Study Record Updates

Last Update Posted (Actual)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00087641

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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