Effects of Footstrike Transition on Tibial Stress Fracture Risk
August 2, 2023 updated by: Jonathan Sinclair, University of Central Lancashire
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
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
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Recreational runner
- 3-years minimum of running experience
- Injury free for 12-months
Exclusion Criteria:
- Injury at baseline
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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
|
|
|
Experimental: Footstrike modification
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress fracture probability
Time Frame: Baseline
|
Probability of stress fracture quantified using a probabilistic modelling approach.
|
Baseline
|
|
Stress fracture probability
Time Frame: 10-weeks
|
Probability of stress fracture quantified using a probabilistic modelling approach.
|
10-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Three-dimensional tibial loading
Time Frame: Baseline
|
Forces applied to the tibia, measured using musculoskeletal simulation.
|
Baseline
|
|
Three-dimensional tibial loading
Time Frame: 10-weeks
|
Forces applied to the tibia, measured using musculoskeletal simulation.
|
10-weeks
|
|
Tibial strain
Time Frame: Baseline
|
Strains experienced by the tibial quantified using finite elements analysis.
|
Baseline
|
|
Tibial strain
Time Frame: 10-weeks
|
Strains experienced by the tibial quantified using finite elements analysis.
|
10-weeks
|
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)
June 1, 2016
Primary Completion (Actual)
June 1, 2019
Study Completion (Actual)
June 1, 2019
Study Registration Dates
First Submitted
March 14, 2023
First Submitted That Met QC Criteria
March 24, 2023
First Posted (Actual)
March 27, 2023
Study Record Updates
Last Update Posted (Actual)
August 7, 2023
Last Update Submitted That Met QC Criteria
August 2, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Footstrike tibial stress
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.