Neurocognitive Exercises for Ankle Instability

August 8, 2025 updated by: Aysenur Erekdag, Istanbul University - Cerrahpasa

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • 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 Backup

Study Locations

  • Turkey
      • Istanbul, Turkey, 34752
        • Acibadem Mehmet Ali Aydinlar University

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Neurocognitive Enriched Exercise
Individuals with a diagnosis of lateral ankle instability who underwent supervised neurocognitive enriched exercise under the guidance of a physiotherapist for 8 weeks, 2 days a week.
Other: Neurocognitive Enriched Exercise
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.
Active Comparator: Multimodal Exercise
Individuals with a diagnosis of lateral ankle instability who underwent supervised routine exercise under the guidance of a physiotherapist for 8 weeks, 2 days a week.
Other: Multimodal Exercise
Supervised and progressively advanced interventions that include strengthening, balance, range of motion, stretching, and mobilization exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
change from baseline at 6 months
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).
change from baseline at 6 months
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).
change from baseline at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 times for 24 weeks
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.
3 times for 24 weeks
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.
3 times for 24 weeks
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.
2 times for 52 weeks
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.
3 times for 24 weeks
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 times for 24 weeks
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.
3 times for 24 weeks
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.
3 times for 24 weeks
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.
3 times for 24 weeks

Collaborators and Investigators

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

Sponsor

Istanbul University - Cerrahpasa

Collaborators

Bezmialem Vakif University
Acıbadem Atunizade Hospital

Investigators

  • Principal Investigator: Ayşenur Erekdağ, MSc, Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

November 1, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

August 11, 2025

Last Update Submitted That Met QC Criteria

August 8, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024_AE_Tez

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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