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

Wounds and Injuries Clinical Trial

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05499871
• Other study ID #: 09082022
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 75
• Est. completion date: September 30, 2024
• Est. primary completion date: September 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Oxygen Consumption
• Running
• Wounds and Injuries

Intervention

Behavioral:
• Gait retraining intervention
Participants will receive a training to modify their footstrike pattern toward a more forefoot strike and increase their cadence by 7.5%.

Device:
• Transition to minimalist footwear.
Participants will receive a running minimalist footwear.

Locations

Country	Name	City	State
Belgium	Guillaume Abran	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Running-related-injuries	Number of running related injuries per participant	At any time during the 12 month follow-up