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Handlebar Grip Related Injury Prevention (GRIP) Study: Are Exposed Metal Handlebar Ends a Risk Factor for Injury? (GRIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02378311
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : January 14, 2016
Sponsor:
Collaborators:
University Hospitals Bristol NHS Foundation Trust
University of Oxford
Information provided by (Responsible Party):
Andrew Neilson, Birmingham Women's and Children's NHS Foundation Trust

Brief 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.


Condition or disease
Injuries Trauma Wounds and Injuries Children Child

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: 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?
Study Start Date : March 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu

Group/Cohort
Cases
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
Controls
Those satisfying the inclusion & exclusion criteria in whom the handlebars were not implicated in the mechanism of injury



Primary Outcome Measures :
  1. Feasibility [ Time Frame: 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.


Secondary Outcome Measures :
  1. Research methodology [ Time Frame: 6 months ]
    To test the research methodology proposed for a future nationwide multicentre study.

  2. Power calculation data collection [ Time Frame: 6 months ]

    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.



Other Outcome Measures:
  1. Number of Cases & Controls [ Time Frame: 6 months ]
    The total number of eligible Cases & Controls identified in each department.

  2. Recruitment [ Time Frame: 6 months ]

    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.


  3. Study acceptability [ Time Frame: 6 months ]

    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.


  4. Use of photographs [ Time Frame: 6 months ]

    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.


  5. Design & resources [ Time Frame: 6 months ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children attending either one of two tertiary paediatric hospital emergency departments and paediatric surgical units in the United Kingdom.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378311


Sponsors and Collaborators
Andrew Neilson
University Hospitals Bristol NHS Foundation Trust
University of Oxford
Investigators
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Principal Investigator: Andrew G Neilson, MBChB, MRCS Birmingham Women's and Children's NHS Foundation Trust
Publications:
Getting to grips with handlebar injuries: a call for collaboration to inform legislative change. British Association of Paediatric Surgeons Annual Congress, Bournemouth 2013.
BSI. BS EN 14766:2005. Mountain bicycles: Safety requirements and test methods. British Standards Institution; 2006.
BSI. BS EN 14619:2005. Roller sports equipment and kick scooters: Safety requirements and test methods. British Standards Institution; 2005.
BSI. BS EN 16054:2012. BMX bicycles: Safety requirements and test methods. British Standards Institution; 2012.
BSI. BS EN ISO 8098:2014. Cycles. Safety requirements for bicycles for young children. British Standards Institution; 2014.
EuroSafe, Injury Database, European Commission, Swansea University, KFV. Injuries in the European Union, Issue 4. Summary of injury statistics for the years 2008-2010. European Association for Injury Prevention and Safety Promotion (EuroSafe); 2013.

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Responsible Party: Andrew Neilson, Clinical Research Fellow, Paediatric Surgery, Birmingham Women's and Children's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02378311    
Other Study ID Numbers: GRIPS-F-V4.15
139699 ( Registry Identifier: IRAS project ID )
15/LO/0311 ( Other Identifier: REC reference )
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Andrew Neilson, Birmingham Women's and Children's NHS Foundation Trust:
Bike
Bicycle
Scooter
Handlebar
Additional relevant MeSH terms:
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Wounds and Injuries