Menu
Recruiting NCT07252219

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

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
This is an observational study: the protocol does not assign a study treatment.
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 Force Sense and Neuromuscular Activation During Submaximal Isometric Contractions in Individuals With and Without Chronic Ankle Instability

Overview

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.

Detailed description

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.

Primary outcome measures

  • Constant Error (CE) [Time frame: Baseline (Day 1, prior to fatigue protocol) and immediately post-fatigue (Day 1, within 5 minutes after fatigue protocol).]
  • Absolute Error (AE) [Time frame: Baseline (Day 1, prior to fatigue protocol) and immediately post-fatigue (Day 1, within 5 minutes after fatigue protocol).]
  • 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).]
  • 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).]
Secondary outcome measures (4)
  • 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).]
  • 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).]
  • 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).]
  • 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.

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
  • Faculty of Health Sciences — Ljubljana

Identifiers

NCT: NCT07252219 · 0120-197/2023/3/isokinetic

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗