- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07252219
Effects of Ankle Evertor Fatigue on Force Sense and Neuromuscular Activation in Subjects With Chronic Ankle Instability
Effects of Ankle Evertor Fatigue on Force Sense and Neuromuscular Activation During Submaximal Isometric Contractions in Individuals With and Without Chronic Ankle Instability
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alan Kacin, PhD, PT, Prof
- Phone Number: +38613001119
- Email: alan.kacin@zf.uni-lj.si
Study Contact Backup
- Name: Tjaž Brezovar
- Phone Number: +38640777919
- Email: tjaz.brezovar@zf.uni-lj.si
Study Locations
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Ljubljana, Slovenia, 1000
- Recruiting
- Faculty of Health Sciences
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Contact:
- Martina Oder, PhD, Dean
- Phone Number: +38613001112
- Email: martina.oder@zf.uni-lj.si
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Principal Investigator:
- Alan Kacin, PhD, PT, Prof
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Sub-Investigator:
- Tjaž Brezovar
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Constant Error (CE)
Time Frame: Baseline (Day 1, prior to fatigue protocol) and immediately post-fatigue (Day 1, within 5 minutes after fatigue protocol).
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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).
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Absolute Error (AE)
Time Frame: Baseline (Day 1, prior to fatigue protocol) and immediately post-fatigue (Day 1, within 5 minutes after fatigue protocol).
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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).
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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).
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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).
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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).
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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 (%).
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Baseline (Day 1, prior to fatigue protocol) and immediately post-fatigue (Day 1, within 5 minutes after fatigue protocol).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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).
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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).
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Baseline (Day 1, prior to fatigue protocol) and immediately post-fatigue (Day 1, within 5 minutes after fatigue protocol).
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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).
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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).
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Baseline (Day 1, prior to fatigue protocol) and immediately post-fatigue (Day 1, within 5 minutes after fatigue protocol).
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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).
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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).
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Baseline (Day 1, prior to fatigue protocol) and immediately post-fatigue (Day 1, within 5 minutes after fatigue protocol).
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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).
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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.
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Baseline (Day 1, prior to fatigue protocol) and immediately post-fatigue (Day 1, within 5 minutes after fatigue protocol).
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0120-197/2023/3/isokinetic
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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