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Effects of Footstrike Transition on Tibial Stress Fracture Risk

Primary Purpose

Tibial Stress Fracture

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Footstrike modification
Control
Sponsored by
University of Central Lancashire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tibial Stress Fracture

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Recreational runner 3-years minimum of running experience Injury free for 12-months Exclusion Criteria: Injury at baseline

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Footstrike modification

    Control

    Arm Description

    Outcomes

    Primary Outcome Measures

    Stress fracture probability
    Probability of stress fracture quantified using a probabilistic modelling approach.
    Stress fracture probability
    Probability of stress fracture quantified using a probabilistic modelling approach.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 14, 2023
    Last Updated
    August 2, 2023
    Sponsor
    University of Central Lancashire
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05786079
    Brief Title
    Effects of Footstrike Transition on Tibial Stress Fracture Risk
    Official Title
    Effects of Footstrike Transition on Tibial Stress Fracture Risk Using Musculoskeletal Simulation, Finite Element Analysis and Probabilistic Modelling - a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2016 (Actual)
    Primary Completion Date
    June 1, 2019 (Actual)
    Study Completion Date
    June 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Central Lancashire

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tibial Stress Fracture

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Footstrike modification
    Arm Type
    Experimental
    Arm Title
    Control
    Arm Type
    Active Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    Footstrike modification
    Intervention Type
    Behavioral
    Intervention Name(s)
    Control
    Primary Outcome Measure Information:
    Title
    Stress fracture probability
    Description
    Probability of stress fracture quantified using a probabilistic modelling approach.
    Time Frame
    Baseline
    Title
    Stress fracture probability
    Description
    Probability of stress fracture quantified using a probabilistic modelling approach.
    Time Frame
    10-weeks
    Secondary Outcome Measure Information:
    Title
    Three-dimensional tibial loading
    Description
    Forces applied to the tibia, measured using musculoskeletal simulation.
    Time Frame
    Baseline
    Title
    Three-dimensional tibial loading
    Description
    Forces applied to the tibia, measured using musculoskeletal simulation.
    Time Frame
    10-weeks
    Title
    Tibial strain
    Description
    Strains experienced by the tibial quantified using finite elements analysis.
    Time Frame
    Baseline
    Title
    Tibial strain
    Description
    Strains experienced by the tibial quantified using finite elements analysis.
    Time Frame
    10-weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Recreational runner 3-years minimum of running experience Injury free for 12-months Exclusion Criteria: Injury at baseline

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effects of Footstrike Transition on Tibial Stress Fracture Risk

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