Effects of Ankle Evertor Fatigue on Perturbed Gait

NCT ID: NCT07273097

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-05

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will investigate the effects of ankle evertor muscle fatigue on gait stability during treadmill walking with mechanical perturbations. Participants will walk at two speeds (0.4 m/s and 1.0 m/s) while random medial and lateral perturbations (\<10% body weight) are applied to the pelvis. Surface EMG from ankle muscles and center of pressure (COP)-based gait parameters (e.g., step length, step width, single support duration, COP trajectory) will be analyzed before and immediately after an isotonic fatigue protocol of the ankle evertors.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is to examine how ankle evertor muscle fatigue affects gait stability and neuromuscular responses during treadmill walking with mechanical perturbations. Perturbations will be applied randomly in the medial or lateral direction, but always shortly after initial foot contact, to specifically challenge ankle stabilization in stance.

The study will include individuals with chronic ankle instability (CAI) and matched healthy controls. In the CAI group, the symptomatic side will be targeted with the fatigue protocol, whereas in healthy controls the tested side will be assigned to match the distribution of sprain laterality in the CAI group.

Walking and perturbation protocol:

Participants will first complete familiarization at 1.0 m/s, including both normal and perturbed walking. After familiarization, the measurements will consist of 2 minutes of unperturbed walking followed by 3 minutes of perturbed walking. The same procedure will then be repeated at 0.4 m/s, with familiarization (normal and perturbed walking) preceding the measurement block.

The fatigue protocol will be applied immediately after these baseline blocks. Following fatigue, participants will immediately perform perturbed walking at 1.0 m/s. The fatigue protocol will then be repeated, followed by perturbed walking at 0.4 m/s.

Fatigue protocol:

Ankle evertor muscles will be fatigued using elastic resistance bands through repeated concentric and eccentric eversion contractions. The task will be paced using a metronome at a rate of one repetition per second, and will continue until the active eversion range of motion decreases by 50% compared to baseline.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Ankle Instability, CAI

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy group

Healthy participants without a history of ankle sprain or self-reported ankle instability. Participants in this group will complete the same experimental protocol as Chronic ankle instability group, which includes treadmill walking at two speeds (0.4 m/s and 1.0 m/s) with and without mechanical perturbations, performed before and after an ankle evertor fatigue protocol. For this group, the fatigued limb will be assigned based on the laterality of ankle sprains observed in the CAI group.

Muscle fatigue

Intervention Type OTHER

The fatigue protocol will consist of repeated concentric-eccentric ankle eversion contractions against elastic resistance at a pace of one repetition per second, guided by a metronome, and performed in a seated position. Fatigue will be defined as a clear inability to perform the full range of eversion, i.e. the range of motion falling below 50% of the initial value despite evident effort by the participant.

Chronic ankle instability group

Participants with chronic ankle instability, defined by a history of recurrent ankle sprains and self-reported instability. Participants in this group will complete the same experimental protocol as Healthy group, which includes treadmill walking at two speeds (0.4 m/s and 1.0 m/s) with and without mechanical perturbations, performed before and after an ankle evertor fatigue protocol. For this group, the fatigued limb will be the symptomatic side.

Muscle fatigue

Intervention Type OTHER

The fatigue protocol will consist of repeated concentric-eccentric ankle eversion contractions against elastic resistance at a pace of one repetition per second, guided by a metronome, and performed in a seated position. Fatigue will be defined as a clear inability to perform the full range of eversion, i.e. the range of motion falling below 50% of the initial value despite evident effort by the participant.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Muscle fatigue

The fatigue protocol will consist of repeated concentric-eccentric ankle eversion contractions against elastic resistance at a pace of one repetition per second, guided by a metronome, and performed in a seated position. Fatigue will be defined as a clear inability to perform the full range of eversion, i.e. the range of motion falling below 50% of the initial value despite evident effort by the participant.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age between 18 and 45 years,
* No history of injuries or surgical procedures to the lower limbs,
* No peripheral or central neurological impairments.


* Age between 18 and 45 years,
* No history of major surgical procedures on the lower limbs
* No peripheral or central neurological impairments,
* Diagnosed chronic ankle instability:

* First ankle sprain occurred at least one year prior to testing,
* At least three months since the most recent ankle sprain,
* Subjective feeling of ankle instability - CAIT (Cumberland Ankle Instability Tool) score \< 24.

Exclusion Criteria

* Other pathologies of the ankle joint.
* Acute pain
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Ljubljana

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alan Kacin

Head of Laboratory

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Rehabilitation Institute Republic of Slovenia - URI Soča

Ljubljana, , Slovenia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Slovenia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Alan Kacin, PhD, PT, Prof

Role: CONTACT

+38613001119

Tjaž Brezovar

Role: CONTACT

+38640777919

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Urška Puh, PhD, PT, Assoc. Prof

Role: primary

+38640577131

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0120-197/2023/3/gait

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Neurocognitive Exercises for Ankle Instability
NCT06567847 NOT_YET_RECRUITING NA