Neurocognitive Exercises for Ankle Instability

NCT06567847 | Not Yet Recruiting

• 1 other identifier: 2024_AE_Tez
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ankle Sprains

Keywords

Neuroplasticity; Reinjury; Chronic ankle instability; Physiotherapy

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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).

  change from baseline at 6 months

Secondary Outcomes (9)

• Ultrasonography

  3 times for 24 weeks

• Numeric Pain Rating Scale

  3 times for 24 weeks

• Joint Range of Motion Evaluation

  3 times for 24 weeks

• Tampa Kinesiophoby Scoring

  3 times for 24 weeks

• Star Excursion Test

  3 times for 24 weeks

Study Arms (2)

Neurocognitive Enriched Exercise

ACTIVE COMPARATOR

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

Multimodal Exercise

ACTIVE COMPARATOR

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

Interventions

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.

Neurocognitive Enriched Exercise

Multimodal Exercise OTHER

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

Multimodal Exercise

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Bezmialem Vakif University: collaborator
• Acıbadem Atunizade Hospital: collaborator

Study Sites (1)

Acibadem Mehmet Ali Aydinlar University

Istanbul, 34752, Turkey (Türkiye)

Location

Related Publications (7)

• Gribble PA, Bleakley CM, Caulfield BM, Docherty CL, Fourchet F, Fong DT, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, Verhagen EA, Vicenzino BT, Wikstrom EA, Delahunt E. Evidence review for the 2016 International Ankle Consortium consensus statement on the prevalence, impact and long-term consequences of lateral ankle sprains. Br J Sports Med. 2016 Dec;50(24):1496-1505. doi: 10.1136/bjsports-2016-096189. Epub 2016 Jun 3.

  PMID: 27259753 BACKGROUND

• Owoeye OBA, Palacios-Derflingher LM, Emery CA. Prevention of Ankle Sprain Injuries in Youth Soccer and Basketball: Effectiveness of a Neuromuscular Training Program and Examining Risk Factors. Clin J Sport Med. 2018 Jul;28(4):325-331. doi: 10.1097/JSM.0000000000000462.

  PMID: 29864071 BACKGROUND

• van Dijk CN, Vuurberg G. There is no such thing as a simple ankle sprain: clinical commentary on the 2016 International Ankle Consortium position statement. Br J Sports Med. 2017 Mar;51(6):485-486. doi: 10.1136/bjsports-2016-096733. Epub 2016 Oct 18. No abstract available.

  PMID: 27797735 BACKGROUND

• Xue X, Ma T, Li Q, Song Y, Hua Y. Chronic ankle instability is associated with proprioception deficits: A systematic review and meta-analysis. J Sport Health Sci. 2021 Mar;10(2):182-191. doi: 10.1016/j.jshs.2020.09.014. Epub 2020 Oct 2.

  PMID: 33017672 BACKGROUND

• Suttmiller AMB, McCann RS. Neural excitability of lower extremity musculature in individuals with and without chronic ankle instability: A systematic review and meta-analysis. J Electromyogr Kinesiol. 2020 Aug;53:102436. doi: 10.1016/j.jelekin.2020.102436. Epub 2020 Jun 1.

  PMID: 32505988 BACKGROUND

• Needle AR, Lepley AS, Grooms DR. Central Nervous System Adaptation After Ligamentous Injury: a Summary of Theories, Evidence, and Clinical Interpretation. Sports Med. 2017 Jul;47(7):1271-1288. doi: 10.1007/s40279-016-0666-y.

  PMID: 28005191 BACKGROUND

• Wilke J, Groneberg DA. Neurocognitive function and musculoskeletal injury risk in sports:A systematic review. J Sci Med Sport. 2022 Jan;25(1):41-45. doi: 10.1016/j.jsams.2021.07.002. Epub 2021 Jul 9.

  PMID: 34303619 BACKGROUND

MeSH Terms

Conditions

Ankle Injuries; Reinjuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Ayşenur Erekdağ, MSc

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayşenur Erekdağ, MSc

CONTACT

+902124012600; aysenurerekdag@gmail.com

Ipek Yeldan, PhD

CONTACT

+902128663700; ipekyeldan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor will not know which participant received which intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There will be an equal number of participants in the two groups randomized by the computer.

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 23, 2024
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

TU (1)