- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06898554
Spinal and Supraspinal Control in Chronic Ankle Instability
Cross-Education Effect of Structured Balance Training Program on Spinal and Supraspinal Control in Athletes with Chronic Ankle Instability
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ayca Yagcioglu, MSc
- Phone Number: +905432800692
- Email: ayca.yagcioglu@yeditepe.edu.tr
Study Locations
-
-
-
Istanbul, Turkey, 34755
- Recruiting
- Yeditepe University
-
Contact:
- Ayca Yagcioglu, MSc
- Phone Number: +905432800692
- Email: ayca.yagcioglu@yeditepe.edu.tr
-
Contact:
- Ayca Yagcioglu, MSc
-
Contact:
- Feyza Şule Hantal, PHd
-
Istanbul, Turkey, 34718
- Recruiting
- Yeditepe University Kosuyolu Hospital
-
Contact:
- Ayca Yagcioglu, MSc
- Phone Number: +905432800692
- Email: ayca.yagcioglu@yeditepe.edu.tr
-
Contact:
- Berrin Aktekin, MD, Professor
-
Contact:
- Gülçin Çelik, MSc
-
Contact:
- Rengin Bilgen, MD
-
Contact:
- Ayca Yagcioglu, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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
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
Sponsor
Investigators
- Principal Investigator: Berrin Aktekin, MD, Professor, Yeditepe University Hospital
- Principal Investigator: Feyza Şule Hantal, PHd, Yeditepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- YeditepeU23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Ankle Injuries
-
Hadassah Medical OrganizationCompleted
-
Oregon State UniversityTerminatedNeural Inhibition | Injuries, AnkleUnited States
-
Georgia State UniversityNational Athletic Trainers' Association Research & Education Foundation (NATA...CompletedChronic Ankle Instability | Ankle Sprains | Ankle RehabilitationUnited States
-
University of VirginiaNot yet recruitingHealthy | Ankle Sprain | Chronic Ankle Instability, CAIUnited States
-
Shaikh Zayed Hospital, LahoreCompletedBimalleolar Ankle FracturePakistan
-
Creighton UniversityCompletedChronic Ankle Instability | Ankle SprainsUnited States
-
Nova Scotia Health AuthorityBauerfeindNot yet recruitingAnkle Fracture | Ankle ArthrodesisCanada
-
University of DelawareCompletedAnkle Sprains | Ankle InstabilityUnited States
-
Naveen PoonaiRecruiting
-
Delta University for Science and TechnologyCompleted
Clinical Trials on The structured balance training protocol
-
University of ManitobaSDM College of Medical Sciences & HospitalUnknown
-
Riphah International UniversityRecruitingDiabetic Peripheral Neuropathy (DPN)Pakistan
-
Cairo UniversityBatterjee Medical CollegeCompletedCommunity-dwelling Older AdultsSaudi Arabia
-
WicabCompletedVestibular Diseases | Gait DisordersUnited States
-
Bezmialem Vakif UniversityEnrolling by invitation
-
National Yang Ming Chiao Tung UniversityCompleted
-
Universitat Internacional de CatalunyaCompletedSubjects With Deep Cervical Muscle Strength DeficitSpain
-
Istanbul Medipol University HospitalRecruitingKnee OsteoarthritisTurkey
-
Universitat Internacional de CatalunyaCompletedCervicogenic HeadacheSpain
-
Universitat Internacional de CatalunyaCompletedMuscle Weakness | Cervical DisabilitySpain