NCT05499871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2022

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

11 days

First QC Date

August 9, 2022

Last Update Submit

May 13, 2025

Conditions

Keywords

Gait retrainingPerformanceInjuries

Outcome Measures

Primary Outcomes (3)

  • 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 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

  • 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

    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

  • Running-related-injuries

    Number of running related injuries per participant

    At any time during the 12 month follow-up

Study Arms (3)

Minimalist footwear

EXPERIMENTAL

Transition toward a minimalist footwear.

Device: Transition to minimalist footwear.

Footstrike pattern

EXPERIMENTAL

Transition toward a forefootstrike pattern.

Behavioral: Gait retraining intervention

Control

NO INTERVENTION

No intervention

Interventions

Participants will receive a training to modify their footstrike pattern toward a more forefoot strike and increase their cadence by 7.5%.

Footstrike pattern

Participants will receive a running minimalist footwear.

Minimalist footwear

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Run 15 km per week since minimum 6 month

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guillaume Abran

Liège, 4000, Belgium

Location

Related Publications (1)

  • Abran G, Schwartz C, Dardenne N, Delvaux F, Croisier JL. Minimalist Footwear and Softer Running Technique Alter Injury Location but Not Incidence in Recreational Endurance Runners. Am J Sports Med. 2026 Jan;54(1):109-117. doi: 10.1177/03635465251392242. Epub 2026 Jan 1.

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 12, 2022

Study Start

September 1, 2022

Primary Completion

September 12, 2022

Study Completion

September 30, 2024

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations