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Recruiting NCT07273097

Effects of Ankle Evertor Fatigue on Perturbed Gait

Observational Chronic Ankle Instability, CAI

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Muscle fatigue.
Who it may be relevant to
Registry conditions: Chronic Ankle Instability, CAI. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovenia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Ankle Evertor Fatigue on Gait Perturbation Responses in Individuals With and Without Chronic Ankle Instability

Overview

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

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.

Interventions

  • Other 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.

Primary outcome measures

  • Surface EMG root mean square (RMS) amplitude of ankle muscles [Time frame: Baseline (Day 1, prior to fatigue protocol) and immediately post-fatigue (Day 1, within 5 minutes after fatigue protocol).]
  • Center of Pressure mediolateral displacement (COPx) [Time frame: Baseline (Day 1, prior to fatigue protocol) and immediately post-fatigue (Day 1, within 5 minutes after fatigue protocol).]
Secondary outcome measures (3)
  • Step Length and width [Time frame: Baseline (Day 1, prior to fatigue protocol) and immediately post-fatigue (Day 1, within 5 minutes after fatigue protocol).]
  • Ground reaction forces (GRF) [Time frame: Baseline (Day 1, prior to fatigue protocol) and immediately post-fatigue (Day 1, within 5 minutes after fatigue protocol).]
  • Ratings of perceived exertion [Time frame: Baseline (Day 1, prior to fatigue protocol) and immediately post-fatigue (Day 1, within 5 minutes after fatigue protocol).]

Eligibility criteria

Inclusion criteria for the healthy control group (no CAI):

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

Inclusion criteria for the chronic ankle instability (CAI) group:

  • 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 for the CAI group:

  • Other pathologies of the ankle joint.
  • Acute pain

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Slovenia · 1 center
  • University Rehabilitation Institute Republic of Slovenia - URI Soča — Ljubljana

Identifiers

NCT: NCT07273097 · 0120-197/2023/3/gait

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗