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Measuring Head Impacts in Sports

Primary Purpose

Brain Injuries, Brain Concussion

Status
Withdrawn
Phase
Locations
United States
Study Type
Observational
Intervention
Head Impact Recording Technology (HIRT)
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Brain Injuries focused on measuring Mild traumatic brain injury

Eligibility Criteria

18 Years - 24 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria College football players

Sites / Locations

  • Penn State University

Outcomes

Primary Outcome Measures

Impact Severity

Secondary Outcome Measures

Full Information

First Posted
May 14, 2003
Last Updated
October 28, 2014
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00060827
Brief Title
Measuring Head Impacts in Sports
Official Title
Head Impact Recording Technology for Field Applications
Study Type
Observational

2. Study Status

Record Verification Date
March 2004
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Head impacts in sports can lead to brain injury even when the participant is wearing a helmet. The forces that contribute to brain injury from sports-related head impacts are not well understood. This study will test a new device to measure the speed of head impacts among football players.
Detailed Description
Each year, 50 to 70 million people in the United States participate in helmeted and unhelmeted sports with the potential for head impacts. Such sports include football, soccer, hockey, basketball, and boxing. Participating in these sports carries the risk of mild traumatic brain injury (MTBI). The biomechanics of head impacts that result in concussions or other MTBIs are not well understood; however, it is thought that such impacts correlate with head accelerations. Currently, there is no system that allows researchers to measure head acceleration in a large number of individuals during actual play. This is a major obstacle in understanding the mechanism of MTBI and its prevention. This study will evaluate a newly designed miniature device that uses Head Impact Recording Technology (HIRT) to quantify head acceleration during impact in actual sports play. One hundred college football players will be enrolled in the study. Data from HIRT-instrumented helmets will be collected during normal team practice and games throughout a 5-month football season. Data collected will be assessed to determine the incidence, magnitude, and duration of head acceleration during impacts on the sports field.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Brain Concussion
Keywords
Mild traumatic brain injury

7. Study Design

Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Head Impact Recording Technology (HIRT)
Primary Outcome Measure Information:
Title
Impact Severity
Time Frame
Immediate

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria College football players
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rick Greenwald, Ph.D.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State University
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States

12. IPD Sharing Statement

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Measuring Head Impacts in Sports

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