NCT06898554

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

March 27, 2025

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

March 21, 2025

Last Update Submit

March 21, 2025

Conditions

Keywords

ankle, joint instability, cross-education, rehabilitation

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    at the baseline and end of the intervention, 8 weeks

Secondary Outcomes (2)

  • Cumberland Ankle Instability Tool

    at the baseline and end of the intervention, 8 weeks

  • Foot and Ankle Ability Measure (FAAM)

    at the baseline and end of the intervention, 8 weeks

Study Arms (3)

Stable Group

EXPERIMENTAL

The intervention will be applied to only the stable ankle of the athletes with unilateral chronic ankle instability.

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.

Other: The structured balance training protocol

Control Group

NO INTERVENTION

No intervention will be applied.

Interventions

The structured balance training protocol consists of 7 exercises including balance and hop stabilization exercises for athletes with chronic ankle instability.

Stable GroupUnstable Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yeditepe University Koşuyolu Hospital

Istanbul, 34718, Turkey (Türkiye)

RECRUITING

Yeditepe University

Istanbul, 34755, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Ankle InjuriesJoint Instability

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Berrin Aktekin, MD, Professor

    Yeditepe University Hospital

    PRINCIPAL INVESTIGATOR
  • Feyza Şule Hantal, PHd

    Yeditepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

March 21, 2025

First Posted

March 27, 2025

Study Start

November 15, 2024

Primary Completion

June 30, 2025

Study Completion

July 31, 2025

Last Updated

March 27, 2025

Record last verified: 2024-11

Locations