NCT07273097

Brief Summary

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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

May 5, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2026

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2026

Completed
Last Updated

April 29, 2026

Status Verified

November 1, 2025

Enrollment Period

12 months

First QC Date

November 26, 2025

Last Update Submit

April 28, 2026

Conditions

Keywords

perturbed walkingfatiguetreadmill

Outcome Measures

Primary Outcomes (2)

  • Surface EMG root mean square (RMS) amplitude of ankle muscles

    Surface EMG RMS amplitude from peroneus longus (PL), tibialis anterior (TA), soleus (SOL), gastrocnemius medialis (GM), and gluteus medius (GMed), recorded bilaterally during treadmill walking. EMG will be time-normalized to the gait cycle (0-100%). The primary epoch is the perturbation step (shortly after initial contact through stance). For each muscle and speed, EMG during perturbed walking will be normalized to matched unperturbed walking.

    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)

    Mediolateral displacement of the center of pressure (COPx) during walking, time-normalized to the gait cycle (0-100%). In addition, COPx will be expressed relative to the sacral marker (COPx-SACRx). Values will be presented in absolute units (cm) and compared between matched perturbed steps at the same walking speed (before and after fatigue).

    Baseline (Day 1, prior to fatigue protocol) and immediately post-fatigue (Day 1, within 5 minutes after fatigue protocol).

Secondary Outcomes (3)

  • Step Length and width

    Baseline (Day 1, prior to fatigue protocol) and immediately post-fatigue (Day 1, within 5 minutes after fatigue protocol).

  • Ground reaction forces (GRF)

    Baseline (Day 1, prior to fatigue protocol) and immediately post-fatigue (Day 1, within 5 minutes after fatigue protocol).

  • Ratings of perceived exertion

    Baseline (Day 1, prior to fatigue protocol) and immediately post-fatigue (Day 1, within 5 minutes after fatigue protocol).

Study Arms (2)

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.

Other: Muscle fatigue

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.

Other: Muscle fatigue

Interventions

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 groupHealthy group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited by convenience sampling from the general population and clinical settings.

You may qualify if:

  • 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.

You may not qualify if:

  • Other pathologies of the ankle joint.
  • Acute pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Rehabilitation Institute Republic of Slovenia - URI Soča

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Fatigue

Interventions

Muscle Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Alan Kacin, PhD, PT, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Laboratory

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 9, 2025

Study Start

May 5, 2025

Primary Completion

April 23, 2026

Study Completion

May 6, 2026

Last Updated

April 29, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

All collected IPD in anonymized form.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
No limit.
Access Criteria
All IPD will be shared upon reasoned request for the purpose of further scientific analysis (i.e. systematic reviews, meta-analyzes, etc.). A proposal describing the planned analyzes must be submitted in writing to the principal investigator, Dr. Alan Kacin, by email to alan.kacin@zf.uni-lj.si.

Locations