Tibial Stress FractureNCT05786079
Effects of Footstrike Transition on Tibial Stress Fracture Risk
A study testing Footstrike modification in people with Tibial Stress Fracture, run by University of Central Lancashire.
Trial summary
Biomechanical literature suggests that runners who utilize a mid or forefoot strike pattern may suffer from a reduced incidence of chronic injuries compared to a rearfoot strike. This investigation examined the effects of a 10-week footstrike transition intervention on tibial stress fracture risk in runners. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tibial Stress Fracture
- What is being tested?
- Footstrike modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 1 Jun 2019
- Phase
- Interventional
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recreational runner
- 3-years minimum of running experience
- Injury free for 12-months
Who cannot join
- Injury at baseline
About this study
Official title: Effects of Footstrike Transition on Tibial Stress Fracture Risk Using Musculoskeletal Simulation, Finite Element Analysis and Probabilistic Modelling - a Pilot Study
Biomechanical literature suggests that runners who utilize a mid or forefoot strike pattern may suffer from a reduced incidence of chronic injuries compared to a rearfoot strike. This investigation examined the effects of a 10-week footstrike transition intervention on tibial stress fracture risk in runners.
- Conditions
- Tibial Stress Fracture
- Being tested
- Footstrike modification, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Footstrike modificationBehavioural
ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Footstrike modification | Experimental | Not described Receives: Behavioral: Footstrike modification |
| Control | Active comparator | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress fracture probability
Probability of stress fracture quantified using a probabilistic modelling approach.
Measured: Baseline
Stress fracture probability
Probability of stress fracture quantified using a probabilistic modelling approach.
Measured: 10-weeks
Secondary outcomes (4)
Three-dimensional tibial loading
Forces applied to the tibia, measured using musculoskeletal simulation.
Measured: Baseline
Three-dimensional tibial loading
Forces applied to the tibia, measured using musculoskeletal simulation.
Measured: 10-weeks
Tibial strain
Strains experienced by the tibial quantified using finite elements analysis.
Measured: Baseline
Tibial strain
Strains experienced by the tibial quantified using finite elements analysis.
Measured: 10-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Jun 2016
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial Stress FractureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Lancashire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Sinclair, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786079
- Sponsor's protocol ID
- Footstrike tibial stress
- Status last verified
- Aug 2023
- First submitted
- 14 Mar 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Footstrike Transition on Tibial Stress Fracture Risk Using Musculoskeletal Simulation, Finite Element Analysis and Probabilistic Modelling - a Pilot Study
- ClinicalTrials.gov ID
- NCT05786079
- Acronym / sponsor ID
- Footstrike tibial stress
- Conditions
- Tibial Stress Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Central LancashireUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 27 Mar 2023 (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.
Biomechanical literature suggests that runners who utilize a mid or forefoot strike pattern may suffer from a reduced incidence of chronic injuries compared to a rearfoot strike. This investigation examined the effects of a 10-week footstrike transition intervention on tibial stress fracture risk in runners.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Footstrike modification | Experimental | Behavioral: Footstrike modification |
| Control | Active comparator | Behavioral: Control |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Recreational runner
- 3-years minimum of running experience
- Injury free for 12-months
Key exclusion criteria (1 listed)
- Injury at baseline
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 |
|---|---|---|
| Footstrike modification | Behavioural | Footstrike modification |
| Control | Behavioural | Control |
Primary outcome
Stress fracture probability
Time frame: Baseline
Probability of stress fracture quantified using a probabilistic modelling approach.
Stress fracture probability
Time frame: 10-weeks
Probability of stress fracture quantified using a probabilistic modelling approach.
4 secondary outcomes
Three-dimensional tibial loading
Time frame: Baseline
Three-dimensional tibial loading
Time frame: 10-weeks
Tibial strain
Time frame: Baseline
Tibial strain
Time frame: 10-weeks
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 7 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Tibial Stress Fracture
Enrolling by invitationPhase 4
Fracture Recovery for Returning to Duty (Teriparatide STRONG)
Stress Fracture of Tibia or Fibula
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.
Questions about this trial
What is this clinical trial studying?
A study testing Footstrike modification in people with Tibial Stress Fracture, run by University of Central Lancashire.
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 1 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 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Stress fracture probability (time frame: Baseline). The study lists 2 primary outcomes in all. 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 7 Aug 2023.