Ankle SprainsNCT06567847
Neurocognitive Exercises for Ankle Instability
A study testing Neurocognitive Enriched Exercise and Multimodal Exercise in people with Ankle Sprains, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- Neurocognitive Enriched Exercise and Multimodal Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2025to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Acibadem Mehmet Ali Aydinlar University
Istanbul, 34752
About this study
Official title: Is a Neurocognitively Enriched Exercise Effective in Reducing Re-Injury Risk and Improving Balance and Proprioception in Individuals With Lateral Ankle Instability?
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.
Read the 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
- Being tested
- Neurocognitive Enriched Exercise, Multimodal Exercise
- Keywords
- Neuroplasticity, Reinjury, Chronic ankle instability, Physiotherapy
- Medical subject headings
- Ankle Injuries, Reinjuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive Enriched ExerciseOther
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 ExerciseOther
Supervised and progressively advanced interventions that include strengthening, balance, range of motion, stretching, and mobilization exercises.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Multimodal Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: change from baseline at 6 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 times for 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study startNov 2025 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be an equal number of participants in the two groups randomized by the computer.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Bezmialem Vakif University, Acıbadem Atunizade Hospital
- Responsible party
- Principal investigator, Aysenur Erekdag, Istanbul University - Cerrahpasa
- Investigators
- Ayşenur Erekdağ, MSc, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567847
- Sponsor's protocol ID
- 2024_AE_Tez
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2024
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27259753Owoeye 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.
PubMed 29864071van 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.
PubMed 27797735Xue 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.
PubMed 33017672Suttmiller 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.
PubMed 32505988Needle 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.
PubMed 28005191Wilke 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.
PubMed 34303619
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is a Neurocognitively Enriched Exercise Effective in Reducing Re-Injury Risk and Improving Balance and Proprioception in Individuals With Lateral Ankle Instability?
- ClinicalTrials.gov ID
- NCT06567847
- Acronym / sponsor ID
- 2024_AE_Tez
- Conditions
- Ankle Sprains
- Keywords
- Neuroplasticity, Reinjury, Chronic ankle instability, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Bezmialem Vakif University, Acıbadem Atunizade Hospital
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There will be an equal number of participants in the two groups randomized by the computer.
| Arm | Type | Receives |
|---|---|---|
| Neurocognitive Enriched Exercise | Active comparator | Other: Neurocognitive Enriched ExerciseIndividuals 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. |
| Multimodal Exercise | Active comparator | Other: Multimodal ExerciseIndividuals 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurocognitive Enriched ExerciseAn 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. | Other | Neurocognitive Enriched Exercise |
| Multimodal ExerciseSupervised and progressively advanced interventions that include strengthening, balance, range of motion, stretching, and mobilization exercises. | Other | Multimodal Exercise |
Primary outcome
Cumberland Ankle Instability Tool (CAIT)
Time frame: change from baseline at 6 months
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.
Surface Electromyography-maximum voluntary isometric contraction
Time frame: change from baseline at 6 months
Electrode placements will be performed in accordance with the European Recommendations from Surface EMG for Non-Invasive Assessment of Muscles (SENIAM).
Surface Electromyography-muscles' normal functional activities
Time frame: change from baseline at 6 months
Electrode placements will be performed in accordance with the European Recommendations from Surface EMG for Non-Invasive Assessment of Muscles (SENIAM).
9 secondary outcomes
Ultrasonography
Time frame: 3 times for 24 weeks
Numeric Pain Rating Scale
Time frame: 3 times for 24 weeks
Joint Range of Motion Evaluation
Time frame: 3 times for 24 weeks
Tampa Kinesiophoby Scoring
Time frame: 3 times for 24 weeks
Star Excursion Test
Time frame: 3 times for 24 weeks
Single Leg Stance Test
Time frame: 3 times for 24 weeks
The Side Hop Test
Time frame: 3 times for 24 weeks
Global Rating of Change Scale-GRC
Time frame: 2 times for 52 weeks
Reproduction Test
Time frame: 3 times for 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Background: PubMed 27259753Gribble 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.
- Background: PubMed 29864071Owoeye 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.
- Background: PubMed 27797735van 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.
- Background: PubMed 33017672Xue 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.
- Background: PubMed 32505988Suttmiller 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.
- Background: PubMed 28005191Needle 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.
- Background: PubMed 34303619Wilke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayşenur Erekdağ, MSc principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurocognitive Enriched Exercise and Multimodal Exercise in people with Ankle Sprains, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşenur Erekdağ, MSc (+902124012600 ext. 4639, aysenurerekdag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumberland Ankle Instability Tool (CAIT) (time frame: change from baseline at 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06567847, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.