Ankle InjuriesNCT06898554
Spinal and Supraspinal Control in Chronic Ankle Instability
A study testing The structured balance training protocol in people with Ankle Injuries and Ankle Sprains, run by Ayca Yagcioglu at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Ankle Injuries, Ankle Sprains
- What is being tested?
- The structured balance training protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Yeditepe University Koşuyolu Hospital
Istanbul, 34718
Ayca Yagcioglu, MSc, +905432800692, ayca.yagcioglu@yeditepe.edu.tr
Berrin Aktekin, MD, Professor
- Recruiting
Yeditepe University
Istanbul, 34755
Ayca Yagcioglu, MSc, +905432800692, ayca.yagcioglu@yeditepe.edu.tr
Feyza Şule Hantal, PHd
About this study
Official title: 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.
- Conditions
- Ankle Injuries, Ankle Sprains
- Being tested
- The structured balance training protocol
- Keywords
- ankle, joint instability, cross-education, rehabilitation
- Medical subject headings
- Ankle Injuries, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The structured balance training protocolOther
The structured balance training protocol consists of 7 exercises including balance and hop stabilization exercises for athletes with chronic ankle instability.
| Study group | Role | What they receive |
|---|---|---|
| Stable Group | Experimental | The intervention will be applied to only the stable ankle of the athletes with unilateral chronic ankle instability. Receives: Other: The structured balance training protocol |
| Unstable Group | Experimental | The intervention will be applied to only the unstable ankle of the athletes with unilateral chronic ankle instability. Receives: Other: The structured balance training protocol |
| Control Group | No intervention | No intervention will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proprioceptive-Stabilometric Assessment
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.
Measured: at the baseline and end of the intervention, 8 weeks
Transcranial Magnetic Stimulation
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.
Measured: at the baseline and end of the intervention, 8 weeks
Hoffman Reflex
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.
Measured: at the baseline and end of the intervention, 8 weeks
Secondary outcomes (2)
Cumberland Ankle Instability Tool
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.
Measured: at the baseline and end of the intervention, 8 weeks
Foot and Ankle Ability Measure (FAAM)
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%.
Measured: at the baseline and end of the intervention, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start15 Nov 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ayca Yagcioglu
- Sponsor type
- University, hospital or other
- Collaborators
- Yeditepe University, Yeditepe University Hospital
- Responsible party
- Sponsor-investigator, Ayca Yagcioglu, Yeditepe University
- Investigators
- Berrin Aktekin, MD, Professor, Principal investigator, Yeditepe University HospitalFeyza Şule Hantal, PHd, Principal investigator, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898554
- Sponsor's protocol ID
- YeditepeU23
- Status last verified
- Nov 2024
- First submitted
- 21 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Education Effect of Structured Balance Training Program on Spinal and Supraspinal Control in Athletes With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT06898554
- Acronym / sponsor ID
- YeditepeU23
- Conditions
- Ankle Injuries, Ankle Sprains
- Keywords
- ankle, joint instability, cross-education, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ayca YagciogluUniversity, hospital or other
- Collaborators
- Yeditepe University, Yeditepe University Hospital
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stable Group | Experimental | Other: The structured balance training protocolThe intervention will be applied to only the stable ankle of the athletes with unilateral chronic ankle instability. |
| Unstable Group | Experimental | Other: The structured balance training protocolThe intervention will be applied to only the unstable ankle of the athletes with unilateral chronic ankle instability. |
| Control Group | No intervention | –No intervention will be applied. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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),
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The structured balance training protocolThe structured balance training protocol consists of 7 exercises including balance and hop stabilization exercises for athletes with chronic ankle instability. | Other | Stable Group, Unstable Group |
Primary outcome
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.
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.
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.
2 secondary outcomes
Cumberland Ankle Instability Tool
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Berrin Aktekin, MD, Professor principal investigator
Yeditepe University Hospital
Feyza Şule Hantal, PHd principal investigator
Yeditepe University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The structured balance training protocol in people with Ankle Injuries and Ankle Sprains, run by Ayca Yagcioglu at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayca Yagcioglu, MSc (+905432800692, ayca.yagcioglu@yeditepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proprioceptive-Stabilometric Assessment (time frame: at the baseline and end of the intervention, 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.