Spinal and Supraspinal Control in Chronic Ankle Instability

March 21, 2025 updated by: Ayca Yagcioglu

Cross-Education Effect of Structured Balance Training Program on Spinal and Supraspinal Control in Athletes with Chronic Ankle Instability

Ankle sprains are common sports injuries that often lead to chronic ankle instability (CAI). Patients with CAI experience deficits in neuromuscular control (NMC), including proprioception and strength. It is believed that damage to the ankle's ligament mechanoreceptors and the peroneal nerve after the initial ankle sprain can cause alterations in NMC, resulting in postural control and dynamic joint stability dysfunction. Inflammation related to recurrent ankle sprains may also contribute to neuromuscular impairments. Evidence suggests that bilateral postural control deficits occur after an ankle sprain, suggesting alterations in the central nervous system (CNS). Rehabilitation for CAI has been shown to lead to bilateral improvements in NMC, potentially due to neural alterations at both the spinal and supraspinal levels. Cross-education, which refers to the muscular crossed effect of unilateral training, has also been proposed as a mechanism for improving contralateral strength in neurologically healthy individuals. While the exact mechanisms underlying cross-education are not yet fully understood, evidence suggests that it involves neural adaptations at both spinal and supraspinal levels. This study aims to investigate the cross-education effect of a 6-week, unilateral balance training on corticomotor excitability, motor neuron pool excitability, and static and dynamic balance in athletes with chronic ankle instability.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34755
        • Recruiting
        • Yeditepe University
        • Contact:
        • Contact:
          • Ayca Yagcioglu, MSc
        • Contact:
          • Feyza Şule Hantal, PHd
      • Istanbul, Turkey, 34718
        • Recruiting
        • Yeditepe University Kosuyolu Hospital
        • Contact:
        • Contact:
          • Berrin Aktekin, MD, Professor
        • Contact:
          • Gülçin Çelik, MSc
        • Contact:
          • Rengin Bilgen, MD
        • Contact:
          • Ayca Yagcioglu, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Volunteering to participate in the study,
  • Being an athlete between the ages of 18-25,
  • Being a player in a field team sport such as basketball, volleyball, and handball,
  • Having a history of at least 2 significant grade II LAS diagnosed by a physician,
  • Related inflammatory symptoms, "giving away" sensation, obtaining a score ≤25 from the Cumberland Ankle Instability Tool (CAIT),
  • A score <90% for the activities of daily living subscale and <80% for the sport subscale from the Foot and Ankle Ability Measure,
  • Recurrent episodes of LAS of the injured ankle which occurred within at least 12 months.

Exclusion Criteria:

  • Acute injury of lower extremity musculoskeletal structures in the last three months,
  • Orthopedic surgery in any of the lower extremities,
  • Bilateral ankle instability,
  • Vestibular or balance disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
No intervention will be applied.
Experimental: Stable Group
The intervention will be applied to only the stable ankle of the athletes with unilateral chronic ankle instability.
Other: The structured balance training protocol
The structured balance training protocol consists of 7 exercises including balance and hop stabilization exercises for athletes with chronic ankle instability.
Experimental: Unstable Group
The intervention will be applied to only the unstable ankle of the athletes with unilateral chronic ankle instability.
Other: The structured balance training protocol
The structured balance training protocol consists of 7 exercises including balance and hop stabilization exercises for athletes with chronic ankle instability.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proprioceptive-Stabilometric Assessment
Time Frame: at the baseline and end of the intervention, 8 weeks
The Prokin PK 252 will be used for proprioceptive-stabilometric assessment of the lower extremities, incorporating static and dynamic evaluations. The sensorimotor assessment will include the monopodal controlled-load proprioceptive control test and its variant with total load. Participants will perform movements with one foot on the platform, with angular displacements converted into electrical impulses for data acquisition. Static balance will be assessed on a stable platform for 30 seconds per ankle under eyes-open and eyes-closed conditions. Dynamic balance will be measured on an unstable platform under the same conditions. Proprioception will be evaluated on an unstable platform for 90 seconds, guiding the platform through horizontal, diagonal, and circular patterns as per the test program.
at the baseline and end of the intervention, 8 weeks
Transcranial Magnetic Stimulation
Time Frame: at the baseline and end of the intervention, 8 weeks

Transcranial Magnetic Stimulation (TMS), a non-invasive neurophysiological technique, will be used to assess motor cortical function. Corticomotor excitability will be evaluated using dual-cone coil TMS to examine adaptations following cross-training after unilateral training. TMS will induce corticospinal volleys of direct (D) and indirect (I) waves.

The resting motor threshold (rMT), a biomarker of upper motor neuron function, will be recorded. EMG recordings will assess corticomotor excitability, with Ag/AgCl electrodes placed on the tibialis anterior, peroneus longus, and gastrocnemius medialis muscles, following SENIAM guidelines.

Participants will be seated in a TMS chair, and the hotspot in the left primary motor cortex will be identified. The MEP amplitude will be assessed at 120% rMT with 10 repetitions, and latency will be recorded. A 15-minute rest will be observed between muscle tests.
at the baseline and end of the intervention, 8 weeks
Hoffman Reflex
Time Frame: at the baseline and end of the intervention, 8 weeks

The H-reflex will be measured to assess motor neuron pool excitability within the spinal loop, aiming to explain the mechanism underlying bilateral adaptations. As a valuable tool for evaluating neurological function in athletes, the H-reflex will provide insights into neurophysiological changes.

EMG signals will be pre-amplified and bandpass filtered between 30-300 Hz and recorded from the peroneus longus, tibialis anterior, and gastrocnemius medialis muscles. The tibial nerve will be stimulated using single 1 ms square-wave pulses applied over the popliteal fossa.

The test sequence will be randomized between stable and unstable ankles, ensuring balanced measurements. H-reflex excitability will be assessed for both ankles before and after the protocol to determine neuromuscular adaptations.
at the baseline and end of the intervention, 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cumberland Ankle Instability Tool
Time Frame: at the baseline and end of the intervention, 8 weeks
Cumberland Ankle Instability Tool (CAIT) containing a 9-item 30-point scale is a valid and reliable questionnaire for distinguishing and measuring the severity of functional instability (FI). Clinically, CAIT is an effective tool for evaluating the severity of FI, monitoring progress, and measuring treatment outcomes. In researches, the CAIT provides the identification, objective definition, and comparison of more homogenous subject groups. Participants scoring 25 or higher are less likely to have FI, while participants scoring 25 or lower are more likely to have FI.
at the baseline and end of the intervention, 8 weeks
Foot and Ankle Ability Measure (FAAM)
Time Frame: at the baseline and end of the intervention, 8 weeks
Foot and Ankle Ability Measure (FAAM) is a self-reported tool improved to assess the physical function of individuals with foot and ankle-related musculoskeletal disorders. The valid and reliable Turkish version of FAAM (FAAM-T) was used (intraclass correlation coefficient [ICC] = 0.97 for FAAM-ADL and 0.94 for the FAAM-S subscales), which is a 29-item questionnaire, including 21-item Activities of Daily Living (ADL) and 8-item Sports subscales. Each answer is scored on a 5-point Likert scale ranging from 0 to 4. The maximum score is 84 points for the ADL subscale and 32 points for the Sports subscale. The total score is calculated as a percentage score ranging from 0% to 100%.
at the baseline and end of the intervention, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ayca Yagcioglu

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Yeditepe University
Yeditepe University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Berrin Aktekin, MD, Professor, Yeditepe University Hospital
  • Principal Investigator: Feyza Şule Hantal, PHd, Yeditepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YeditepeU23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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