Effects of Footstrike Transition on Tibial Stress Fracture Risk

Sponsor

University of Central Lancashire (Other)

Overall Status

Completed

CT.gov ID

NCT05786079

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Tibial Stress Fracture	Behavioral: Footstrike modification Behavioral: Control	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Effects of Footstrike Transition on Tibial Stress Fracture Risk Using Musculoskeletal Simulation, Finite Element Analysis and Probabilistic Modelling

Actual Study Start Date :

Jun 1, 2016

Actual Primary Completion Date :

Jun 1, 2019

Actual Study Completion Date :

Jun 1, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Footstrike modification

Behavioral: Footstrike modification

Active Comparator: Control

Behavioral: Control

Outcome Measures

Primary Outcome Measures

Stress fracture probability [Baseline]
Probability of stress fracture quantified using a probabilistic modelling approach.
Stress fracture probability [10-weeks]
Probability of stress fracture quantified using a probabilistic modelling approach.

Secondary Outcome Measures

Three-dimensional tibial loading [Baseline]
Forces applied to the tibia, measured using musculoskeletal simulation.
Three-dimensional tibial loading [10-weeks]
Forces applied to the tibia, measured using musculoskeletal simulation.
Tibial strain [Baseline]
Strains experienced by the tibial quantified using finite elements analysis.
Tibial strain [10-weeks]
Strains experienced by the tibial quantified using finite elements analysis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Recreational runner
3-years minimum of running experience
Injury free for 12-months

Exclusion Criteria:

Injury at baseline

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Central Lancashire

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jonathan Sinclair, Principal Investigator and Professor, University of Central Lancashire

ClinicalTrials.gov Identifier:

NCT05786079

Other Study ID Numbers:

Footstrike tibial stress

First Posted:

Mar 27, 2023

Last Update Posted:

Mar 30, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fractures, Bone

Fractures, Stress

Study Results

No Results Posted as of Mar 30, 2023