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NCT Number: NCT06567847

Neurocognitive Exercises for Ankle Instability

In the general population, 19.0-26.6 per 1000 cases of ankle instability have been reported, while in the athletic population, the rate is 11.3 per 1000. Ankle instability also predisposes individuals to recurrent instability, leading to persistent symptoms. After ankle injuries, temporary increases in afferent activity, along with long-term deficits in somatosensory information from ligaments, may cause central neuroplasticity that affects sensorimotor function. This central neuroplasticity can lead to permanent dysfunctions in the affected limb, thereby increasing the likelihood of developing and maintaining chronic ankle instability (CAI). In addition to the association between impaired balance and reduced proprioception with CAI, it has been reported that the central nervous system may fail to manage joint stress due to its inability to discern load on the ligaments.

Impaired neurocognition has been linked to decreased performance and higher rates of re-injury. Deficiencies in neuromuscular control, motor learning, or other neurocognitive components related to an individual's performance and safety may affect the ability to respond appropriately in a dynamic environment. Any deficiencies in these neurocognitive processes can hinder the successful completion of tasks.

The aim of this study is to comparatively examine the effects of neurocognitively enriched rehabilitation versus traditional rehabilitation on re-injury risk, balance, and proprioception in individuals with a history of ankle instability.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Acibadem Mehmet Ali Aydinlar University

Istanbul, 34752, Turkey (Türkiye)

About this study

Voluntary participants who have been diagnosed with lateral ankle instability will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into two groups. Study groups will be as follows: a) Neurocognitive Enriched Exercise, b) Multimodal Exercise.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The documented unilateral ankle instability confirmed through clinical examinations (drawer test, talar tilt test) and MRI in cases requiring differential diagnosis.
  • A history of an initial ankle sprain occurring at least 6 months ago.
  • The presence of a recurrent sense of giving way that started at least 6 months ago and has been intermittently persistent.

Exclusion criteria

  • Presence of a history of previous surgery in the lower extremity.
  • Identification of organic and non-organic lesions such as cartilage injuries, periarticular tendon tears, and impingement syndromes.
  • The existence of a fracture accompanying instability in the foot-ankle.
  • Presence of congenital deformities in the foot-ankle.
  • Diagnosis of talus osteochondral lesion.
  • Diagnosis of ankle arthritis.
  • Presence of medial ligament lesion.
  • Existence of peripheral neuropathy.
  • Presence of additional rheumatological diseases.
  • Regular moderate-level exercise for at least 3 days a week in the last 6 months.

Treatment and study plan

Neurocognitive Enriched Exercise

Other

An intervention planned, progressed, and conducted under the supervision of a physiotherapist, which enriches strengthening, balance, range of motion, stretching, and mobilization exercises with neurocognitive elements.

Multimodal Exercise

Other

Supervised and progressively advanced interventions that include strengthening, balance, range of motion, stretching, and mobilization exercises.

Primary outcomes

  1. Cumberland Ankle Instability Tool (CAIT)

    Time frame: change from baseline at 6 months

    It is a 30-point, 9-item scale measuring the severity of functional ankle instability. Lower scores indicate functional ankle instability. The Minimal Clinically Important Difference for this valid and reliable scale is 3 points.

  2. Surface Electromyography-maximum voluntary isometric contraction

    Time frame: change from baseline at 6 months

    Electrode placements will be performed in accordance with the European Recommendations from Surface EMG for Non-Invasive Assessment of Muscles (SENIAM).

  3. Surface Electromyography-muscles' normal functional activities

    Time frame: change from baseline at 6 months

    Electrode placements will be performed in accordance with the European Recommendations from Surface EMG for Non-Invasive Assessment of Muscles (SENIAM).

Secondary outcomes

  1. Ultrasonography

    Time frame: 3 times for 24 weeks

    The pennation angles of the peroneal, gastrocnemius, and tibialis anterior muscle groups will be evaluated and recorded using ultrasonographic imaging. The pennation angle will be defined as the angle between the muscle fascicle and the superficial aponeurosis.

  2. Numeric Pain Rating Scale

    Time frame: 3 times for 24 weeks

    Pain during activity in the ankle will be assessed with a pain NPRS, a numbered scale of 11 points. On this scale, "0" indicates no pain, and "10" indicates the most severe pain imaginable.

  3. Joint Range of Motion Evaluation

    Time frame: 3 times for 24 weeks

    During the assessments, three repeat measurements will be made using an electronic goniometer. For goniometric measurement, the pivot point will be placed on the lateral malleolus. The fixed arm will be kept parallel to the lateral midline of the fibula. The moving arm, on the other hand, will follow the lateral midline of the 5th metatarsal bone.

  4. Tampa Kinesiophoby Scoring

    Time frame: 3 times for 24 weeks

    It is a 17-item scale developed to assess the fear of movement/re-injury. The lowest possible score on the test is 17; the highest score is 68; and a score higher than 37 is an indicator of poor health outcomes.

  5. Star Excursion Test

    Time frame: 3 times for 24 weeks

    Physical performance that requires strength, flexibility, and proprioception is assessed through a dynamic test evaluating dynamic postural control and lower extremity injury risk associated with musculoskeletal injuries. The protocol of the test involves maintaining balance on the ipsilateral leg while reaching as far as possible with the contralateral leg.

  6. Single Leg Stance Test

    Time frame: 3 times for 24 weeks

    Participants' standing balance will be assessed. Initially, one foot will be positioned on a firm and flat surface with the entire lower extremity in full extension, while the other lower extremity is positioned with the hip and knee flexed at 90 degrees. With their eyes closed, participants will start the timing when the foot not being tested loses contact with the ground, and the timing will stop when they place their foot back on the ground or when there is a significant increase in body sway.

  7. The Side Hop Test

    Time frame: 3 times for 24 weeks

    It is a test that assesses the functional stability of patients. Patients will be asked to stand on one leg on the affected extremity. They will then be required to perform 10 jumps over two pre-determined strips that are spaced 30 cm apart.

  8. Global Rating of Change Scale-GRC

    Time frame: 2 times for 52 weeks

    It will be used to evaluate patient satisfaction. It is designed to determine the amount of improvement or worsening of the patient over time.

    In our study, GRC consisting of 5 levels between -2 and +2 value ranges (-2: I am much worse, -1: I am worse, 0: I am the same, 1: I am better, 2: I am much better) was preferred.

  9. Reproduction Test

    Time frame: 3 times for 24 weeks

    While the eyes of the individuals are closed, the ankle joints will be positioned and a goniometric measurement will be performed. Then, the patient will be brought to the starting position and asked to achieve the same movement. The difference between the two measurements will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayşenur Erekdağ, MSc

CONTACT

[email protected]

+902124012600 ext. 4639

Ipek Yeldan, PhD

CONTACT

[email protected]

+902128663700

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Collaborators

  • Acıbadem Atunizade Hospital
  • Bezmialem Vakif University

Registry information

Official study title

Is a Neurocognitively Enriched Exercise Effective in Reducing Re-Injury Risk and Improving Balance and Proprioception in Individuals With Lateral Ankle Instability?

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 23, 2024
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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