Effects of Footstrike Transition on Tibial Stress Fracture Risk

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: Tibial Stress Fracture
• Intervention / Treatment: Behavioral: Control; Behavioral: Footstrike modification

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	Behavioral: Control
Experimental: Footstrike modification	Behavioral: Footstrike modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress fracture probability	Probability of stress fracture quantified using a probabilistic modelling approach.	Baseline
Stress fracture probability	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	Forces applied to the tibia, measured using musculoskeletal simulation.	Baseline
Three-dimensional tibial loading	Forces applied to the tibia, measured using musculoskeletal simulation.	10-weeks
Tibial strain	Strains experienced by the tibial quantified using finite elements analysis.	Baseline
Tibial strain	Strains experienced by the tibial quantified using finite elements analysis.	10-weeks

Collaborators and Investigators

• Sponsor: University of Central Lancashire

Study record dates

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: Wounds and Injuries; Fractures, Bone; Fractures, Stress
• 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