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Effect of a Gait Retraining Intervention and a Minimalist Footwear Transition on Foot-ankle Strength, Running Economy and Injury in Endurance Runners.

Primary Purpose

Running, Wounds and Injuries, Oxygen Consumption

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Gait retraining intervention
Transition to minimalist footwear.
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Running focused on measuring Gait retraining, Performance, Injuries

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Guillaume Abran

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Minimalist footwear

Footstrike pattern

Control

Arm Description

Transition toward a minimalist footwear.

Transition toward a forefootstrike pattern.

No intervention

Outcomes

Primary Outcome Measures

Change in foot-ankle strength
Measure of maximal voluntary isometric strength of ankle plantar flexors, hallux flexors, lesser toe flexors with hand held dynamometer.
Change in running economy
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
Running-related-injuries
Number of running related injuries per participant

Secondary Outcome Measures

Full Information

First Posted
August 9, 2022
Last Updated
May 9, 2023
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT05499871
Brief Title
Effect of a Gait Retraining Intervention and a Minimalist Footwear Transition on Foot-ankle Strength, Running Economy and Injury in Endurance Runners.
Official Title
Comparison Between Gait Retraining Intervention With a Transitioning Toward Minimalist Footwear on the Foot-ankle Strength, Running Economy and Injury Incidence in Endurance Runners: a One-year Follow up Study.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
September 12, 2022 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
The main aim is to determine whether a gait retraining intervention 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. In function of their distribution, participants will receive either nothing (control group) or minimalist footwear or a training to modify their footstrike pattern toward a more forefoot strike.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Running, Wounds and Injuries, Oxygen Consumption
Keywords
Gait retraining, Performance, Injuries

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Minimalist footwear
Arm Type
Experimental
Arm Description
Transition toward a minimalist footwear.
Arm Title
Footstrike pattern
Arm Type
Experimental
Arm Description
Transition toward a forefootstrike pattern.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Gait retraining intervention
Intervention Description
Participants will receive a training to modify their footstrike pattern toward a more forefoot strike and increase their cadence by 7.5%.
Intervention Type
Device
Intervention Name(s)
Transition to minimalist footwear.
Intervention Description
Participants will receive a running minimalist footwear.
Primary Outcome Measure Information:
Title
Change in foot-ankle strength
Description
Measure of maximal voluntary isometric strength of ankle plantar flexors, hallux flexors, lesser toe flexors with hand held dynamometer.
Time Frame
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
Title
Change in running economy
Description
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
Time Frame
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
Title
Running-related-injuries
Description
Number of running related injuries per participant
Time Frame
At any time during the 12 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Guillaume Abran
City
Liège
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of a Gait Retraining Intervention and a Minimalist Footwear Transition on Foot-ankle Strength, Running Economy and Injury in Endurance Runners.

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