An observational study in Injuries, Trauma and Wounds and Injuries, sponsored by Andrew Neilson. Completed. Open to participants aged 1 Day to 15 Years. Per ClinicalTrials.gov, last updated 2016-01-14.
Sponsored by Andrew Neilson · Observational
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.
Injuries are the most common cause of death of children aged 1-14 years in the European Union[11]. In the United States cyclist injuries are the 3rd most common mechanism of injury in 7-13 year olds, after motor vehicle collisions (MVC) and falls[1]. Bicycle injuries have remained one of the most common causes of paediatric abdominal trauma for over 60 years[2,3]. The vast majority (95-98%) of child cyclists admitted due to abdominal trauma are over 5 years old[2,3]. As with most mechanisms of injury, boys are injured more frequently than girls. Around three quarters of injured child cyclists are boys[12].
In a recent UK study, handlebar end impact was the mechanism that most frequently resulted in major intra-abdominal trauma in children. Impact with a handlebar end was implicated in 29% of cases. This was ahead of falls (20%), pedestrians (8%) and MVC occupants (8%)[3]. A study conducted in Australia found 15% of child cyclist injuries involved impact with a handlebar, and 10% of all child cyclist injuries were abdominal handlebar injuries[4]. A study in Philadelphia found that 8% of all paediatric bicycle-related trauma admissions involved handlebars impacting the abdomen resulting in an injury with an Abbreviated Injury Scale (AIS) score of 2 or greater[13].
The majority of handlebar injury case series reported in the literature relate to children's abdominal injuries. The peak incidence occurs between 6 and 14 years of age[4]. However, adults can also sustain serious handlebar related injuries[14-16] and 36% of all handlebar injured patients sustain only extra-abdominal injuries[4]. It is not just pedal cyclists who are at risk of these injuries. Incidents also involve non-motorized kick scooters, moto-cross bikes, motorbikes and quad bikes[3,4].
Crash investigations have found that serious handlebar injuries often occur after apparently minor incidents; they are not unique to riders performing stunts or those riding BMX bikes[5,6]. There is a typical sequence of events common to many of these handlebar injuries[5]. The child loses control of the bike and begins to fall. The front wheel rotates through 90 degrees so that it is perpendicular to the child's body. The child continues to fall forwards, landing on the upturned handlebar end.
Children's bikes and scooters often have damaged rubber grips with exposed metal handlebar ends. This occurs through day-to-day use. Each time the child drops their bike or scooter on its side, the handlebar end contacts the ground. When it does so, the metal tube inside the rubber grip cuts into that rubber. With time, a circle is cut from the rubber end, exposing the metal pipe within.
Handlebar end injuries can occur both when the handlebar ends are exposed and when they are intact. Two studies from the 1990s have looked at the condition of the handlebar end implicated in such injuries[5,6].
Acton et al published a series of 21 patients who reported handlebar impact as the cause of their injuries. Re-interview found that metal handlebar ends were exposed on bikes of all 10 children who sustained a major abdominal injury, whilst exposed handlebar ends were present on only one bike of 8 respondents with minor abdominal injuries[6].
Winston et al included detailed analysis on 4 riders who sustained serious abdominal injuries due to landing on a handlebar end. They found that these serious injuries occurred in 3 riders despite the presence of protective rubber covering on the handlebar ends. The rider who impacted an exposed metal handlebar end, however, had a particularly serious injury. He was a 6-year-old boy who sustained a life threatening liver laceration[5].
Identifying if there is an association between the condition of handlebar grips and the likelihood of sustaining an injury is the ultimate aim of the main GRIP study. This feasibility study aims to test the intended methodology prior to rolling out a nationwide multicentre study. The feasibility study will allow power calculations to be performed for the nationwide study. The primary outcome of the nationwide study will address whether children falling onto exposed metal handlebar ends are at a greater risk of sustaining an injury than those who fall onto handlebars with intact rubber grips. A sub-study will explore whether there is any relationship between injury severity and grip condition.
Our clinical experience tells us that serious handlebar injuries do occur even when handlebar grips are intact. The investigators also know through anecdotes that some riders fall onto their handlebar ends and never attend hospital because no injury or only a minor injury is sustained. The cases presenting to tertiary paediatric units represent the 'tip of the iceberg'. A study to accurately identify the number of children who fall onto a handlebar but do not present to hospital is unlikely to be feasible. This is why the investigators have designed a case-controlled study.
If the nationwide multicentre GRIP study rejects the null hypothesis, then the investigators can focus on passive injury prevention strategies relating to handlebar ends. There are two aspects that could easily be addressed by safety standards. Grip durability and grip end minimum diameter. Improved durability should reduce the number of bikes or scooters in circulation with exposed metal handlebar ends. Larger diameter ends distribute any end-on impact over a larger surface area and hence reduce the pressure exerted on the point of contact.
Currently only one of the many applicable European safety standards includes a drop test of handlebar grip durability[9]. This standard for BMX bikes was introduced in 2012. However, the drop test has not been included in the more recently published standard for Bicycles for Young Children[10].
A minimum grip diameter requirement has been included in the standard for Bicycles for Young Children. It specifies that handlebars shall be fitted with handlebar grips, and that such grips shall be of resilient material and shall have an enlarged and covered end not less than 40mm in diameter[10]. That standard applies only to bikes suitable for children up to around 5 years of age. There is no such minimum handlebar end diameter requirement applied to bicycles ridden by children over 5 years of age, or to kick scooters. These standards simply require the handlebar to be fitted with handgrips or end plugs[7-9].
If, however, the nationwide multicentre GRIP study accepts the null hypothesis, the investigators can focus handlebar-related injury prevention on more complex mechanical solutions such as steering limiters or compressible handlebar ends, and on design of effective protective clothing. Some of the secondary outcomes the investigators propose addressing will be useful if it is found that exposed handlebar ends are not a risk factor for this injury mechanism.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 50 is below the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →This is the only study on the registry with Andrew Neilson as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Children attending either one of two tertiary paediatric hospital emergency departments and paediatric surgical units in the United Kingdom.
Exclusion Criteria:
Those satisfying the inclusion \& exclusion criteria whose injury involved impact with the handlebar end who have sustained an injury more severe than a skin or subcutaneous tissue contusion from an end-on handlebar impact
Those satisfying the inclusion \& exclusion criteria in whom the handlebars were not implicated in the mechanism of injury
Feasibility
To demonstrate the feasibility of a study researching whether or not exposed handlebar ends are a risk factor for injury in child bike and scooter riders.
Time frame: 6 months
Research methodology
To test the research methodology proposed for a future nationwide multicentre study.
Time frame: 6 months
Power calculation data collection
To collect data required to do power calculations for a future nationwide multi centre study: The percentage of riders who did impact the handlebar end. The ratio of recruited Cases to Controls. The percentage who don't know whether they impacted the handlebar end. The percentage who don't know which handlebar end they hit. The proportion of intact, damaged and exposed handlebar ends in each group. The percentage whose handlebar ends are both in the same condition.
Time frame: 6 months
Number of Cases & Controls
The total number of eligible Cases \& Controls identified in each department.
Time frame: 6 months
Recruitment
The number identified by recruitment step 1a, 1b and 1c. Number recruited by reminder letters. Number of recruited participants who are eligible. Number completing questionnaire Part 2 without need for reminder. Number who respond to SMS, email, telephone or postal reminders for questionnaire Part 2. Proportion of responses to questionnaire Part 2 completed online versus using paper questionnaire. Proportion of incomplete versus complete questionnaire datasets. Number invited to participate in a telephone interview (Part 3). Number consenting to that interview; qualitative reasons for non-participation. Number completing that interview.
Time frame: 6 months
Study acceptability
Qualitative feedback from participants about the acceptability and design of the study. Qualitative feedback from recruiters about their willingness to recruit potential participants, the acceptability and design of the study.
Time frame: 6 months
Use of photographs
What proportion upload photos of their handlebar ends using the online form. What proportion of those using the paper questionnaire Part 2 email photos. Can an investigator grade handlebar condition using photos submitted by participants? If so, what is the inter-observer agreement between the parent's assessment and that of the investigator using the photograph.
Time frame: 6 months
Design & resources
Assess and record where possible the workload and resources required in each department. Record staff questions to aid compilation of an FAQ document for the national study.
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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