Clinical trial NCT06567847: Neurocognitive Exercises for Ankle Instability
Official title: Is a Neurocognitively Enriched Exercise Effective in Reducing Re-Injury Risk and Improving Balance and Proprioception in Individuals With Lateral Ankle Instability?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ankle Sprains
Keywords: Neuroplasticity
Reinjury
Chronic ankle instability
Physiotherapy
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Bezmialem Vakif University
name: Acıbadem Atunizade Hospital
First posted: 2024-08-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be an equal number of participants in the two groups randomized by the computer.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cumberland Ankle Instability Tool (CAIT)
timeFrame: change from baseline at 6 months
measure: Surface Electromyography-maximum voluntary isometric contraction
timeFrame: change from baseline at 6 months
measure: Surface Electromyography-muscles' normal functional activities
timeFrame: change from baseline at 6 months
Secondary outcomes:
measure: Ultrasonography
timeFrame: 3 times for 24 weeks
measure: Numeric Pain Rating Scale
timeFrame: 3 times for 24 weeks
measure: Joint Range of Motion Evaluation
timeFrame: 3 times for 24 weeks
measure: Tampa Kinesiophoby Scoring
timeFrame: 3 times for 24 weeks
measure: Star Excursion Test
timeFrame: 3 times for 24 weeks
measure: Single Leg Stance Test
timeFrame: 3 times for 24 weeks
measure: The Side Hop Test
timeFrame: 3 times for 24 weeks
measure: Global Rating of Change Scale-GRC
timeFrame: 2 times for 52 weeks
measure: Reproduction Test
timeFrame: 3 times for 24 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Mehmet Ali Aydinlar University
Study officials:
affiliation: Bezmialem Vakif University
name: Ayşenur Erekdağ, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.