NCT07252219

Brief Summary

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.

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
50

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 15, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2026

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2026

Completed
Last Updated

April 29, 2026

Status Verified

November 1, 2025

Enrollment Period

11 months

First QC Date

September 10, 2025

Last Update Submit

April 28, 2026

Conditions

Keywords

chronic ankle instabilityforce sensemuscle fatigueproprioception

Outcome Measures

Primary Outcomes (4)

  • Constant Error (CE)

    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).

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

  • Absolute Error (AE)

    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).

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

  • Variable Error (VE)

    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).

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

  • Coefficient of Variation (CV) of generated force

    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 (%).

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

Secondary Outcomes (4)

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

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

  • Surface EMG median frequency of peroneus longus mucle

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

  • Maximal voluntary isometric contraction (MVIC)

    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 will complete the same experimental protocol as the group of chronic ankle instability, including a fatigue protocol of the ankle evertors

Chronic ankle instability group

Participants with chronic ankle instability, defined by a history of recurrent ankle sprains and self-reported instability. Participants will complete the same experimental protocol as the control group, including a fatigue protocol of the ankle evertors.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences

Ljubljana, 1000, Slovenia

RECRUITING

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

September 10, 2025

First Posted

November 26, 2025

Study Start

May 15, 2025

Primary Completion

April 14, 2026

Study Completion

May 4, 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