Risk FactorNCT03867890
Relationship Between Footwear Consumer Behaviour and Lower Extremity Injuries
An observational study of Risk Factor and Sports Injury, run by University Ghent at 1 site in Belgium.
Trial summary
A prospective cohort study was set-up in leisure-time walkers and runners. Potential risk factors in consumer behaviour were obtained by means of a baseline questionnaire related to the acquisition of current walking or running shoes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Risk Factor, Sports Injury, Footwear
- How many people
- 580 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2012to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Leisure-time runners and walkers
Who may be able to join
- walk or run at least 10 kilometres per week
- maintain a minimal distance of ten kilometres per week, for a period of 24 weeks
- wear one and the same pair of shoes during walking/running activities during this period
Who cannot join
- systemic disease, cardiac problems or diabetes
- complaints at the lower extremities in the last two weeks,
- surgery at the lower extremities in the last three years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Consumer Behaviour Towards Footwear Predisposing for Lower Extremity Injuries in Runners and Walkers? A Prospective Study
A prospective cohort study was set-up in leisure-time walkers and runners. Potential risk factors in consumer behaviour were obtained by means of a baseline questionnaire related to the acquisition of current walking or running shoes. Information on injuries sustained during a 24 week period after the baseline questionnaire was obtained in 104 runners and 104 walkers using a 2-weekly questionnaire.
- Conditions
- Risk Factor, Sports Injury, Footwear
- Being tested
- no intervention
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
injury occurence
self-reported running or walking injury questionnaire
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study startJun 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk FactorStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867890
- Sponsor's protocol ID
- B670201214347
- Status last verified
- May 2023
- First submitted
- 6 Mar 2019
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Consumer Behaviour Towards Footwear Predisposing for Lower Extremity Injuries in Runners and Walkers? A Prospective Study
- ClinicalTrials.gov ID
- NCT03867890
- Acronym / sponsor ID
- B670201214347
- Conditions
- Risk Factor, Sports Injury, Footwear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 8 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective cohort study was set-up in leisure-time walkers and runners. Potential risk factors in consumer behaviour were obtained by means of a baseline questionnaire related to the acquisition of current walking or running shoes. Information on injuries sustained during a 24 week period after the baseline questionnaire was obtained in 104 runners and 104 walkers using a 2-weekly questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Leisure-time runners and walkers
Key inclusion criteria (3 listed)
- walk or run at least 10 kilometres per week
- maintain a minimal distance of ten kilometres per week, for a period of 24 weeks
- wear one and the same pair of shoes during walking/running activities during this period
Key exclusion criteria (3 listed)
- systemic disease, cardiac problems or diabetes
- complaints at the lower extremities in the last two weeks,
- surgery at the lower extremities in the last three years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention | Other | – |
Primary outcome
injury occurence
Time frame: 24 weeks
self-reported running or walking injury questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Risk Factor and Sports Injury, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
injury occurence (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.