Neurocognitive Exercises for Ankle Instability
ConditionAnkle Sprains
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorIstanbul University - Cerrahpasa
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Neurocognitive Enriched Exercise
Other interventionAn 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 interventionSupervised and progressively advanced interventions that include strengthening, balance, range of motion, stretching, and mobilization exercises.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Neurocognitive Enriched ExerciseActive comparator 1 intervention
Group B: Multimodal ExerciseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 months3
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 monthsSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Istanbul University - Cerrahpasa
Lead sponsor
Bezmialem Vakif University
Collaborator
Acıbadem Atunizade Hospital
Collaborator
Source ClinicalTrials.gov
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