- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06819332
Pedal Cycle Related Trauma at the Royal London Hospital
February 7, 2025 updated by: Barts & The London NHS Trust
An Observational Study of Pedal Cycle Related Trauma at the Royal London Hospital
Bespoke is an observational, prospective, cohort study.
The aim of this study is to explore injury patterns of patients who require admission to the Royal London Hospital (RLH) Emergency Department (ED)or outpatient clinics as a result of any collision involving a bicycle.
Secondary objectives are to determine the circumstances around cycling injury and to explore the effect of cycling collisions on the return to work, activities of daily living and cycling.
All patients that attend the Emergency Department of the Royal London Hospital following an injury sustained while cycling, will be invited to take part in the study.
Participants will be asked to answer a questionnaire about their cycling routines as well as provide information about the location, conditions and events surrounding their collision.
Patients' recovery will be followed by the study team using the electronic health record and by reviewing the patients' notes.
Morbidity and mortality data will be completed at death, discharge or 28 days from admission (whichever comes first).
The patients will be followed up in person, email, or via telephone at 6 weeks following their initial admission.
The research team hosted a Patient and Public Involvement (PPI) event, to determine which outcome measures were important for the public to investigate.
It was found that the majority of the group felt it was important to follow up return to work, return to cycling and return to activities of daily living in any patients who have had a cycling collision.
These outcomes will be measured at the 6 week follow up.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
644
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, E1 1BB
- Royal London Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients who attend the Royal London HOSPT
Description
Inclusion Criteria:
- All patients who are 16 years and older attending the Royal London Hospital Emergency department who have been injured while riding a bicycle (pedal cycle)
- All patients who are 16 years and older who are transferred to the Royal London Hospital, either for inpatient or outpatient care, who were injured whilst riding a bicycle
Exclusion Criteria:
- Patients who have been injured while involved in activities other than cycling
- Patients that decline to take part in the study
- Patients who are 15 years or younger
- Off road cyclists
- motorbike riders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Epidemiology of bicycle related accidents in London in patients who present to the Royal London Hospital.
Time Frame: 14 days
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Measure epidemiology of bicycle related accidents in London
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14 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To map collision hotspots in London and quantify and draw patients' quality of life after injury using using EQ-5D - EuroQol as a measuring tool to assess patient generic health status and SF-12 to measure functional health and well-being.
Time Frame: 6 Weeks (+/-2 weeks)
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Using EQ-5D - EuroQol as a measuring tool to assess patient generic health.
5-level EQ-5D version by EuroQol for descriptive and visual analogue scale.
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6 Weeks (+/-2 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2015
Primary Completion (Actual)
November 1, 2017
Study Completion (Actual)
November 1, 2017
Study Registration Dates
First Submitted
April 19, 2017
First Submitted That Met QC Criteria
February 7, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 7, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 158400
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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