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临床试验/NCT02378311
NCT02378311已完成不适用

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 Neilson0 个研究点目标入组 50 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
主要终点
Feasibility

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
1 Day 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children 0-15 years inclusive
  • Presenting to either of the study hospitals for assessment or treatment
  • Sustained an injury or suspected to have sustained an injury (i.e. AIS >=0)
  • Due to an incident involving any non-motorized bicycle, tricycle or kick scooter

排除标准

  • Incidents where the injured child was involved in a motor vehicle collision
  • Incidents where the injured child was injured by another rider (e.g. injured child run over by a cyclist)
  • Incidents involving a bicycle fitted with 'bull bars'
  • Patients for whom neither parent / guardian is fluent in English (if the history is clear from a parent, the patient will be eligible for inclusion)
  • If an eligible patient is dead on arrival the family will not be invited to participate, and they will not subsequently be contacted
  • If an eligible patient dies during their admission, they will be withdrawn from further involvement in the study and the family will not be contacted

结局指标

主要结局

Feasibility

时间窗: 6 months

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.

次要结局

  • Research methodology(6 months)
  • Power calculation data collection(6 months)

研究者

发起方
Andrew Neilson
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Andrew Neilson

Clinical Research Fellow, Paediatric Surgery

Birmingham Women's and Children's NHS Foundation Trust

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