CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT02378311
NCT02378311N/ACompleted

A Multicentre Observational Case-controlled Feasibility Study: In Children Who Ride Bikes or Scooters, is the Risk of Sustaining a Serious Injury Greater When Metal Handlebar Ends Are Exposed Than When They Are Covered by Intact Grips?

Andrew Neilson·observational·Posted Mar 4, 2015·Updated Jan 14, 2016

In Brief

An observational study for Injuries and 4 related conditions. Completed, enrolled 50 participants.

Detailed Summary

Cycling injuries are the 3rd most common mechanism of injury in 7-13 year olds\[1\]. Bicycle injuries have remained one of the commonest causes of paediatric abdominal trauma for over 60 years\[2,3\]. 15% of child cyclist injuries involve impact with a handlebar; two-thirds of those are abdominal injuries\[4\]. Handlebar impact is now the commonest mechanism of major paediatric abdominal injury\[3\]. Serious handlebar injuries often occur after apparently minor falls; they are not unique to riders performing stunts\[5\]. One small study found that the metal handlebar ends were often exposed on bikes of children sustaining severe abdominal injuries\[6\]. Most European safety standards do not test grip durability\[7-10\]. Day-to-day use can damage rubber grips, exposing the underlying metal handlebar tube. This feasibility study aims to test the research methods that will be used in a subsequent nationwide multicentre study. The main study will investigate the association between injuries and handlebar grip condition. Children attending study hospitals with any bicycle or kick scooter injury will be invited to participate. Parents of injured children will be invited to complete questionnaires regarding circumstances surrounding the injury and condition of the handlebar ends on the bike or scooter involved. Clinical information regarding the injury will also be collected. The handlebar end condition will be compared between children sustaining a handlebar end injury \[Cases\] and riders whose injury did not involve the handlebar \[Controls\]. If exposed handlebar ends are more prevalent amongst riders with handlebar end injuries, injury prevention strategies can focus on methods to prevent damage occurring to grips through day-to-day use. If no such association is found, prevention strategies can be focused elsewhere, such as on design of effective protective clothing. Data collection for this feasibility study will occur between March 2015 and September 2015. The Chief Investigator, Mr. Andrew Neilson, funds the feasibility study.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 4, 2015
Enrollment StartMar 1, 2015
Primary CompletionSep 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 11.3 years ago