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Effect of Footstrike Pattern and Footwear Manipulation on Foot-ankle Strength, Running Economy and Injury in Endurance Runners.

Sponsor
University of Liege (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05499871
Collaborator
(none)
75
Enrollment
1
Location
3
Arms
16
Anticipated Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main aim is to determine whether a transitioning toward a forefoot strike pattern will improve the strength of the foot-ankle muscle, the running economy and reduce the injury incidence in a one-year follow-up study. The secondary aim is to seek whether a minimal foot-ankle strength is necessary to reduce the risk to sustain to a running-related-injury to transit toward a forefoot strike pattern or toward a minimalist footwear for an endurance runner.

Participants will be assessed at baseline, at 2 month follow-up, at 6 month follow-up and at 12 month follow-up. Assessment will be composed by questionnaires, a foot screening, maximal voluntary isometric strength of foot-ankle muscle with hand held dynamometer. Then, participants will run on a treadmill at self-paced and at 10 km/h with to measure their running economy and their footstrike pattern. Thus, participants will receive a program of strengthening for the foot-ankle complex. In function of their distribution, participants will receive either minimalist footwear or a training to modify their footstrike pattern toward a more forefoot strike.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Footstrike pattern modification toward a more forefootstrike pattern.
  • Device: Transition to minimalist footwear.
  • Other: Control
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Comparison Between a Transitioning Toward a Forefoot Strike Pattern and a Transitioning Toward Minimalist Footwear on the Foot-ankle Strength, Running Economy and Injury Incidence in Endurance Runners: a One-year Follow up Study.
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Sep 12, 2022
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Minimalist footwear

Transition toward a minimalist footwear + foot-ankle strengthening.

Device: Transition to minimalist footwear.
Participants will receive a program of strengthening for the foot-ankle complex and a running minimalist footwear.
Experimental: Footstrike pattern

Transition toward a forefootstrike pattern + foot-ankle strengthening.

Behavioral: Footstrike pattern modification toward a more forefootstrike pattern.
Participants will receive a program of strengthening for the foot-ankle complex and a training to modify their footstrike pattern toward a more forefoot strike.
Other Names:
  • Only foot-ankle strenghtening

    		•
    Active Comparator: Control

    Foot-ankle strengthening

    Other: Control
    Participants will receive a program of strengthening for the foot-ankle complex.

    Outcome Measures

    Primary Outcome Measures

    1. Change in foot-ankle strength [Change from Baseline foot-ankle strength at 2 month follow-up, Change from Baseline foot-ankle strength at 6 month follow-up, Change from Baseline foot-ankle strength at 12 month follow-up]

      Measure of maximal voluntary isometric strength of ankle plantar flexors, hallux flexors, lesser toe flexors with hand held dynamometer.

    2. Change in running economy [Change from Baseline running-economy at 2 month follow-up, Change from Baseline running economy at 6 month follow-up, Change from Baseline running economy at 12 month follow-up]

      Measure of oxygen uptake was during steady state run on a treadmill at 10 km/h and at self-paced with was recorded using Ergocard device. Then, running economy was caluled with the formula: Energetic cost = 16.89 * Vo2 + 4.84*VCo2

    3. Running-related-injuries [At any time during the 12 month follow-up]

      Number of running related injuries per participant

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Run 15 km per week since minimum 6 month
    Exclusion Criteria:

    • No running related injuries in the last 3 month before the participation.

    • Have never worn minimalist footwear (minimalist index superior to 70%)

    • Have never modified their footstrike pattern

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guillaume Abran Liège Belgium 4000

    Sponsors and Collaborators

    • University of Liege

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abran Guillaume, PhD student, University of Liege
    ClinicalTrials.gov Identifier:
    NCT05499871
    Other Study ID Numbers:
    • 09082022
    First Posted:
    Aug 12, 2022
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Abran Guillaume, PhD student, University of Liege
    Gait retraining
    Performance
    Injuries
    Additional relevant MeSH terms:
    Wounds and Injuries

    Study Results

    No Results Posted as of Aug 19, 2022