Neurocognitive Exercises for Ankle Instability

NCT ID: NCT06567847

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2028-02-29

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.

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.

Conditions

Ankle Sprains

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Neurocognitive Enriched Exercise

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Multimodal Exercise

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Multimodal Exercise

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: collaborator

Acıbadem Atunizade Hospital

OTHER

Sponsor Role: collaborator

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Aysenur Erekdag

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayşenur Erekdağ, MSc

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

Acibadem Mehmet Ali Aydinlar University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Ayşenur Erekdağ, MSc

Role: CONTACT

aysenurerekdag@gmail.com

+902124012600 ext. 4639

Ipek Yeldan, PhD

Role: CONTACT

ipekyeldan@gmail.com

+902128663700

References

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.

Reference Type: BACKGROUND

PMID: 27259753 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29864071 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27797735 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33017672 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32505988 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28005191 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34303619 (View on PubMed)

Other Identifiers

2024_AE_Tez

Identifier Type: -

Identifier Source: org_study_id