Kinematics of Youth (Age 12-15) on Stationary All Terrain... | NCT00692029

Studies
Kinematics of Youth (Age 12-15) on Stationary All Terrain Vehicles

NCT00692029

Sponsor

University of Kentucky

Status

Completed

Last Update Posted

Feb 21, 2011Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Jun 4, 2008

First Submission Date that Met QC Criteria

Jun 5, 2008

First Posted Date

Jun 6, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2011

Last Update Posted Date

Feb 21, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To assess the relationship between pre-teen/teen height, age, weight, gender, and body proportions and shape and size of youth and comfort and safety when operating adult All Terrain Vehicles (ATV).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quantify relationship of youth size/shape to comfort and safety when operating adult ATV		1 session

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

males
age 12-15
a minimum level of physical skill to mount and dismount the vehicle
ability to speak and understand English.

We have used this age group because it is the most often injured group and represents an entire age group for ATV size restriction (other age groups not studied here are 6-11, and 16 or greater).

Exclusion Criteria:

inability to participate in physical education without restrictions
visual acuity < 20/40 corrected
females
emancipated minors.

We have excluded females to gain the most consistent body dimensions in this preliminary study.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

PreTeen and Teenage children

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew C. Bernard, M.D.	University of Kentucky	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kentucky		Lexington	Kentucky	40536	United States