An interventional study of Neurocognitive Enriched Exercise and Multimodal Exercise in Ankle Sprains, sponsored by Istanbul University - Cerrahpasa. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-08-11.
Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Treatment
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.
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.
352 studies on the registry are indexed under Ankle Injuries; 72 are open to participants now.
This study's planned enrollment of 36 is below the median of 56 across 273 interventional studies indexed under Ankle Injuries.
Browse Ankle Injuries studies →Istanbul University - Cerrahpasa is the lead sponsor of 680 studies on the registry; 208 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
Supervised and progressively advanced interventions that include strengthening, balance, range of motion, stretching, and mobilization exercises.
Cumberland Ankle Instability Tool (CAIT)
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.
Time frame: change from baseline at 6 months
Surface Electromyography-maximum voluntary isometric contraction
Electrode placements will be performed in accordance with the European Recommendations from Surface EMG for Non-Invasive Assessment of Muscles (SENIAM).
Time frame: change from baseline at 6 months
Surface Electromyography-muscles' normal functional activities
Electrode placements will be performed in accordance with the European Recommendations from Surface EMG for Non-Invasive Assessment of Muscles (SENIAM).
Time frame: change from baseline at 6 months
Ultrasonography
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.
Time frame: 3 times for 24 weeks
Numeric Pain Rating Scale
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.
Time frame: 3 times for 24 weeks
Joint Range of Motion Evaluation
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.
Time frame: 3 times for 24 weeks
Tampa Kinesiophoby Scoring
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.
Time frame: 3 times for 24 weeks
Star Excursion Test
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.
Time frame: 3 times for 24 weeks
Single Leg Stance Test
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.
Time frame: 3 times for 24 weeks
The Side Hop Test
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.
Time frame: 3 times for 24 weeks
Global Rating of Change Scale-GRC
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.
Time frame: 2 times for 52 weeks
Reproduction Test
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.
Time frame: 3 times for 24 weeks
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Istanbul University - Cerrahpasa