RunningNCT05499871
Effect of a Gait Retraining Intervention and a Minimalist Footwear Transition on Foot-ankle Strength, Running Economy and Injury in Endurance Runners.
A study testing Gait retraining intervention and Transition to minimalist footwear. in people with Running and Wounds and Injuries, run by University of Liege at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Running, Wounds and Injuries, Oxygen Consumption
- What is being tested?
- Gait retraining intervention and Transition to minimalist footwear.
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Run 15 km per week since minimum 6 month
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Running, Wounds and Injuries, Oxygen Consumption
- Being tested
- Gait retraining intervention, Transition to minimalist footwear.
- Keywords
- Gait retraining, Performance, Injuries
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait retraining interventionBehavioural
Participants will receive a training to modify their footstrike pattern toward a more forefoot strike and increase their cadence by 7.5%.
Transition to minimalist footwear.Device
Participants will receive a running minimalist footwear.
| Study group | Role | What they receive |
|---|---|---|
| Minimalist footwear | Experimental | Transition toward a minimalist footwear. Receives: Device: Transition to minimalist footwear. |
| Footstrike pattern | Experimental | Transition toward a forefootstrike pattern. Receives: Behavioral: Gait retraining intervention |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in foot-ankle strength
Measure of maximal voluntary isometric strength of ankle plantar flexors, hallux flexors, lesser toe flexors with hand held dynamometer.
Measured: 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
Measured: 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
Measured: At any time during the 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Sep 2022
- Primary completion12 Sep 2022
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RunningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abran Guillaume, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499871
- Sponsor's protocol ID
- 09082022
- Status last verified
- May 2025
- First submitted
- 9 Aug 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41476413
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05499871
- Acronym / sponsor ID
- 09082022
- Conditions
- Running, Wounds and Injuries, Oxygen Consumption
- Keywords
- Gait retraining, Performance, Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Minimalist footwear | Experimental | Device: Transition to minimalist footwear.Transition toward a minimalist footwear. |
| Footstrike pattern | Experimental | Behavioral: Gait retraining interventionTransition toward a forefootstrike pattern. |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Run 15 km per week since minimum 6 month
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait retraining interventionParticipants will receive a training to modify their footstrike pattern toward a more forefoot strike and increase their cadence by 7.5%. | Behavioural | Footstrike pattern |
| Transition to minimalist footwear.Participants will receive a running minimalist footwear. | Device | Minimalist footwear |
Primary outcome
Change in foot-ankle strength
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
Measure of maximal voluntary isometric strength of ankle plantar flexors, hallux flexors, lesser toe flexors with hand held dynamometer.
Change in running economy
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
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
Time frame: At any time during the 12 month follow-up
Number of running related injuries per participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Derived from this study: PubMed 41476413Abran 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait retraining intervention and Transition to minimalist footwear. in people with Running and Wounds and Injuries, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in foot-ankle strength (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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05499871, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.