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NCT Number: NCT07252219

Effects of Ankle Evertor Fatigue on Force Sense and Neuromuscular Activation in Subjects With Chronic Ankle Instability

The goal of this observational study is to investigate whether ankle evertor muscle fatigue impairs force perception and alters neuromuscular activation patterns during submaximal isometric contractions, and whether these effects differ between individuals with chronic ankle instability (CAI) and individuals without CAI.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Health Sciences

Ljubljana, 1000, Slovenia

Location status: Recruiting

Location contact

Alan Kacin, PhD, PT, Prof

PRINCIPAL_INVESTIGATOR

Martina Oder, PhD, Dean

CONTACT

[email protected]

+38613001112

Tjaž Brezovar

SUB_INVESTIGATOR

About this study

Participants will first be familiarized with the research protocol for approximately 20 minutes. After a short break, the experimental protocol with data collection will begin and last between 45 and 60 minutes. Measurements will be performed on the side where the participant reports symptoms of chronic ankle instability. In cases of bilateral CAI, the leg with the lower CAIT score will be tested.

Participants will be tested on an isokinetic dynamometer (Humac Norm, CSMi, USA) in a semi-recumbent position with the hip and knee flexed to ensure comfort and alignment. The trunk and tested leg will be secured with straps to minimize accessory movement. After initial maximal voluntary isometric contraction (MVIC) of ankle evertors, participants will perform force-matching tasks at 25% and 50% of MVIC. Each trial will consist of 5 seconds with visual feedback followed by 5 seconds without feedback, repeated three times per intensity. After completing these tasks, participants will undergo a fatigue protocol for the ankle evertors. After the fatigue protocol, participants will repeat the force-matching tasks at both 25% and 50% MVIC.

The muscle fatigue protocol consists of consecutive isotonic contractions of ankle eversion, performed through the full range of motion at 30% of MVIC torque until visible fatigue. Fatigue will be defined as a clear inability to perform full range of eversion, i.e. the range of motion fell below 10% of the initial value despite evident effort by the participant. The test will be paced using a metronome, with a 1-second concentric and a 1-second eccentric phase to ensure consistent movement velocity.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Constant Error (CE)

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

    Muscle force sense will be assessed by the accuracy of force reproduction during force-matching tasks.

    Constant Error (CE) will be calculated as the mean difference in force (Nm) between reproduction with and without visual feedback during the middle three seconds, averaged across three repetitions at each load level.

    Unit of measure: Newton-meters (Nm).

  2. Absolute Error (AE)

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

    Muscle force sense will be assessed by the accuracy of force reproduction during force-matching tasks.

    Absolute Error (AE) will be calculated as the mean absolute difference in force (Nm) between reproduction with and without visual feedback during the middle three seconds, averaged across three repetitions at each load level.

    Unit of measure: Newton-meters (Nm).

  3. Variable Error (VE)

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

    Muscle force sense will be assessed by the accuracy of force reproduction during force-matching tasks.

    Variable Error (VE) will be calculated as the standard deviation of errors across three repetitions at each load level.

    Unit of measure: Newton-meters (Nm).

  4. Coefficient of Variation (CV) of generated force

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

    Ratio of the standard deviation to the mean force during the middle three seconds of sustained contraction in each trial, calculated separately for trials with and without visual feedback. Unit of Measure: Percentage (%).

Secondary outcomes

  1. 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).

    RMS amplitude from surface EMG signals of the peroneus longus, tibialis anterior, soleus, and gastrocnemius medialis will be obtained during the fatigue protocol, MVIC and force-matching task. Unit of Measure: millivolts (mV).

  2. Surface EMG median frequency of peroneus longus mucle

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

    Median frequency of EMG signals will be obtained from the peroneus longus during the fatigue protocol, the maximal voluntary isometric contraction (MVIC) and force-matching tasks. Frequency values will be averaged across repetitions. Unit of Measure: Hertz (Hz).

  3. Maximal voluntary isometric contraction (MVIC)

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

    MVIC of the ankle evertors will be measured at the beginning of the protocol to determine the target force for submaximal isometric contractions, and repeated immediately after the fatigue protocol to assess the effectiveness of fatigue, expressed in Newton-meters (Nm).

  4. 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).

    Description: Ratings of perceived exertion (RPE) will be assessed at the end of each fatigue protocol using the Borg 10 category-ratio scale, with 0 is no effort and 10 is an extreme physical effort.

Study contacts

Contact information is provided by the study sponsor or research team.

Alan Kacin, PhD, PT, Prof

CONTACT

[email protected]

+38613001119

Tjaž Brezovar

CONTACT

[email protected]

+38640777919

Sponsors and collaborators

Lead sponsor

University of Ljubljana

Other

Registry information

Official study title

Effects of Ankle Evertor Fatigue on Force Sense and Neuromuscular Activation During Submaximal Isometric Contractions in Individuals With and Without Chronic Ankle Instability

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 26, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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