HealthyATVNCT00692029
Kinematics of Youth (Age 12-15) on Stationary All Terrain Vehicles
An observational study of Healthy, run by University of Kentucky at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 15 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- Men only
- Healthy volunteers accepted
- Child
Study population: PreTeen and Teenage children
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Healthy
- Keywords
- Normal, Healthy Volunteers
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify relationship of youth size/shape to comfort and safety when operating adult ATV
Measured: 1 session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Investigators
- Andrew C. Bernard, M.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692029
- Sponsor's protocol ID
- 08-0300-F1V
- Acronym
- ATV
- Status last verified
- Feb 2011
- First submitted
- 4 Jun 2008
- Last updated
- 21 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinematics of Youth (Age 12-15) on Stationary All Terrain Vehicles
- ClinicalTrials.gov ID
- NCT00692029
- Acronym / sponsor ID
- ATV / 08-0300-F1V
- Conditions
- Healthy
- Keywords
- Normal, Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 15 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- PreTeen and Teenage children
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantify relationship of youth size/shape to comfort and safety when operating adult ATV
Time frame: 1 session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew C. Bernard, M.D. principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Kentucky at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantify relationship of youth size/shape to comfort and safety when operating adult ATV (time frame: 1 session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2011.