Chronic Ankle InstabilityNCT07004114
Effects of Neurocognitive Training on Chronic Ankle Instability
A study testing Neurocognitive training group in people with Chronic Ankle Instability and Balance, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This study aimed to investigate the effects of neurocognitive training on pain, proprioception, injury-related fear, functional, and neurocognitive performance in athletes with chronic ankle instability (CAI). Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Chronic Ankle Instability, Balance, Neurocognitive
- What is being tested?
- Neurocognitive training group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Sep 2023to 3 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged between 10 and 18 years
- At least 2 years of active athletic participation
- History of ankle sprain with at least 2 inflammatory symptoms (e.g., pain, swelling)
- The most recent sprain occurred at least 3 months prior to the study start date
- A score of 11 or above on the FABIT (Simon et al., 2012)
- A score of ≤27 on the CAIT (Yin et al., 2022)
- Willingness to participate in the study
Who cannot join
- History of hip/pelvis, knee, or ankle surgery within the past year
- History of ankle fracture
- Diagnosis of a neurological disorder
- Presence of vestibular disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Neurocognitive Training on Pain, Proprioception, Injury Anxiety, and Functional and Neurocognitive Performance in Athletes With Chronic Ankle Instability
Aim: This study aimed to investigate the effects of neurocognitive training on pain, proprioception, injury-related fear, functional, and neurocognitive performance in athletes with chronic ankle instability (CAI).
Materials and Methods: A total of 30 athletes with CAI, with a mean age of 11.10±1.06 years and residing in Balıkesir, were included in the study. Participants were randomly assigned into two groups using simple randomization: the intervention group (n=15) and the control group (n=15). Two participants from the control group were excluded from the final analyses due to missing post-intervention assessments. The intervention group received a neurocognitive training program conducted twice a week for four weeks, following an initial familiarization week. The training was progressively administered on flat ground, balance mat, BOSU, and inverted BOSU. Both groups were evaluated before and after the 4-week intervention using the following measures: the Identification of Functional Ankle Instability (IdFAI), the Cumberland Ankle Instability Tool (CAIT), pain intensity, proprioception, fear of re-injury, Y Balance Test (YBT), Side Hop Test, Reactive Balance Test (RBT), and Upper Extremity Choice Reaction Time Test.
Results: The results were analyzed.
- Conditions
- Chronic Ankle Instability, Balance, Neurocognitive
- Being tested
- Neurocognitive training group
- Keywords
- Cognitive Load, Ankle Instability, RBT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive training groupOther
Neurocognitive training is a rehabilitation approach that, unlike traditional treatment methods which primarily focus on improving physical performance, emphasizes cognitive functions and psychometric skills. It is a program developed by integrating motor learning strategies and cognitive challenges into neuromuscular training. These cognitive challenges include tasks requiring quick reactions, motor-motor or cognitive-motor tasks (dual-task), congruent and incongruent tasks, exercises involving mathematical calculations (working memory), and response inhibition tasks.
| Study group | Role | What they receive |
|---|---|---|
| Neurocognitive training group | Experimental | Neurocognitive training is a program developed by incorporating motor learning strategies and cognitive challenges into neuromuscular training. Cognitive challenges included tasks requiring quick reactions, motor-motor or cognitive-motor tasks (dual-task), congruent and incongruent tasks, exercises combined with mathematical calculations (working memory), and response inhibition tasks. Receives: Other: Neurocognitive training group |
| Control group | No intervention | The control group continued their training and no additional intervention was applied. Four weeks after their initial assessment, the same assessments were applied again with the study group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Ankle Instability Assessment Using the Identification of Functional Ankle Instability Questionnaire (IDFAI)
The IDFAI is a self-reported questionnaire consisting of 9 items designed to identify the presence and severity of functional ankle instability. Scores range from 0 to 37, with higher scores indicating greater instability. A score above 11 suggests the presence of instability. Scores are unitless numeric values representing the severity of symptoms and frequency of ankle sprains.
Measured: from the beginning of the study until the end of the 4th week
Functional Ankle Instability Evaluation Using the Cumberland Ankle Instability Tool (CAIT)
The CAIT is a self-assessment tool with 9 items measuring subjective ankle instability. Scores range from 0 (severe instability) to 30 (no instability). A score of 27 or below indicates functional ankle instability. The score is a unitless numeric value that reflects the level of perceived instability and risk of recurrent sprains.
Measured: from the beginning of the study until the end of the 4th week
Pain Severity Assessment-Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a 10 cm line ranging from "No pain" to "Worst imaginable pain." Participants mark their pain intensity on the line, which is measured in centimeters to quantify pain severity. This unitless numeric score reflects pain intensity at rest, during training, and post-training in ankles with instability history.
Measured: from the beginning of the study until the end of the 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start6 Sep 2023
- Primary completion1 Nov 2024
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Chronic Ankle InstabilityStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Tekin, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004114
- Sponsor's protocol ID
- 2023/13
- Status last verified
- May 2025
- First submitted
- 17 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohammadi F. Comparison of 3 preventive methods to reduce the recurrence of ankle inversion sprains in male soccer players. Am J Sports Med. 2007 Jun;35(6):922-6. doi: 10.1177/0363546507299259. Epub 2007 Mar 22.
PubMed 17379918Walker JM, Brunst CL, Chaput M, Wohl TR, Grooms DR. Integrating neurocognitive challenges into injury prevention training: A clinical commentary. Phys Ther Sport. 2021 Sep;51:8-16. doi: 10.1016/j.ptsp.2021.05.005. Epub 2021 May 19.
PubMed 3415363518) Tekin E, Ünver F. Klinik Nörobilişsel Fonksiyonel Performans Testleri: Geleneksel Derleme. Turkiye Klinikleri Journal of Sports Sciences, 2023;15(2).
Tassignon B, Verschueren J, Delahunt E, Smith M, Vicenzino B, Verhagen E, Meeusen R. Criteria-Based Return to Sport Decision-Making Following Lateral Ankle Sprain Injury: a Systematic Review and Narrative Synthesis. Sports Med. 2019 Apr;49(4):601-619. doi: 10.1007/s40279-019-01071-3.
PubMed 30747379Verschueren J, Tassignon B, Verhagen E, Meeusen R. The interaction of acute physical fatigue with three traditional functional performance tests and the reactive balance test. Phys Ther Sport. 2021 May;49:188-195. doi: 10.1016/j.ptsp.2021.03.004. Epub 2021 Mar 17.
PubMed 33756239Simon J, Donahue M, Docherty C. Development of the Identification of Functional Ankle Instability (IdFAI). Foot Ankle Int. 2012 Sep;33(9):755-63. doi: 10.3113/FAI.2012.0755.
PubMed 22995264Plisky PJ, Gorman PP, Butler RJ, Kiesel KB, Underwood FB, Elkins B. The reliability of an instrumented device for measuring components of the star excursion balance test. N Am J Sports Phys Ther. 2009 May;4(2):92-9.
PubMed 2150911413) Olsson L, Lund H, Henriksen M, Rogind H, Bliddal H, Danneskiold Samsøe B. Test-retest reliability of a knee joint position sense measurement method in sitting and prone position. Advances in Physiotherapy. 2004;6(1):37-47.
Obuz T, Topcu ZG. The effects of exercises with a Pilates ball on balance, reaction time and dual-task performance of kindergarten children. J Comp Eff Res. 2022 Jun;11(8):583-593. doi: 10.2217/cer-2021-0293. Epub 2022 May 6.
PubMed 35514277Loizidis T, Nikodelis T, Bakas E, Kollias I. The effects of dry needling on pain relief and functional balance in patients with sub-chronic low back pain. J Back Musculoskelet Rehabil. 2020;33(6):953-959. doi: 10.3233/BMR-181265.
PubMed 32310156Hiller CE, Refshauge KM, Bundy AC, Herbert RD, Kilbreath SL. The Cumberland ankle instability tool: a report of validity and reliability testing. Arch Phys Med Rehabil. 2006 Sep;87(9):1235-41. doi: 10.1016/j.apmr.2006.05.022.
PubMed 16935061Hertel J. Functional instability following lateral ankle sprain. Sports Med. 2000 May;29(5):361-71. doi: 10.2165/00007256-200029050-00005.
PubMed 10840868Gribble PA, Delahunt E, Bleakley C, Caulfield B, Docherty C, Fourchet F, Fong DT, Hertel J, Hiller C, Kaminski T, McKeon P, Refshauge K, van der Wees P, Vicenzino B, Wikstrom E. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. Br J Sports Med. 2014 Jul;48(13):1014-8. doi: 10.1136/bjsports-2013-093175. Epub 2013 Nov 19.
PubMed 24255768Fong DT, Hong Y, Chan LK, Yung PS, Chan KM. A systematic review on ankle injury and ankle sprain in sports. Sports Med. 2007;37(1):73-94. doi: 10.2165/00007256-200737010-00006.
PubMed 17190537Engeroff T, Giesche F, Niederer D, Gerten S, Wilke J, Vogt L, Banzer W. Explaining Upper or Lower Extremity Crossover Effects of Visuomotor Choice Reaction Time Training. Percept Mot Skills. 2019 Aug;126(4):675-693. doi: 10.1177/0031512519841755. Epub 2019 Apr 30.
PubMed 31039674
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Neurocognitive Training on Pain, Proprioception, Injury Anxiety, and Functional and Neurocognitive Performance in Athletes With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT07004114
- Acronym / sponsor ID
- 2023/13
- Conditions
- Chronic Ankle Instability, Balance, Neurocognitive
- Keywords
- Cognitive Load, Ankle Instability, RBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 4 Jun 2025 (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.
Aim: This study aimed to investigate the effects of neurocognitive training on pain, proprioception, injury-related fear, functional, and neurocognitive performance in athletes with chronic ankle instability (CAI).
Materials and Methods: A total of 30 athletes with CAI, with a mean age of 11.10±1.06 years and residing in Balıkesir, were included in the study. Participants were randomly assigned into two groups using simple randomization: the intervention group (n=15) and the control group (n=15). Two participants from the control group were excluded from the final analyses due to missing post-intervention assessments. The intervention group received a neurocognitive training program conducted twice a week for four weeks, following an initial familiarization week. The training was progressively administered on flat ground, balance mat, BOSU, and inverted BOSU. Both groups were evaluated before and after the 4-week intervention using the following measures: the Identification of Functional Ankle Instability (IdFAI), the Cumberland Ankle Instability Tool (CAIT), pain intensity, proprioception, fear of re-injury, Y Balance Test (YBT), Side Hop Test, Reactive Balance Test (RBT), and Upper Extremity Choice Reaction Time Test.
Results: The results were analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurocognitive training group | Experimental | Other: Neurocognitive training groupNeurocognitive training is a program developed by incorporating motor learning strategies and cognitive challenges into neuromuscular training. Cognitive challenges included tasks requiring quick reactions, motor-motor or cognitive-motor tasks (dual-task), congruent and incongruent tasks, exercises combined with mathematical calculations (working memory), and response inhibition tasks. |
| Control group | No intervention | –The control group continued their training and no additional intervention was applied. Four weeks after their initial assessment, the same assessments were applied again with the study group. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Aged between 10 and 18 years
- At least 2 years of active athletic participation
- History of ankle sprain with at least 2 inflammatory symptoms (e.g., pain, swelling)
- The most recent sprain occurred at least 3 months prior to the study start date
- A score of 11 or above on the FABIT (Simon et al., 2012)
Key exclusion criteria (4 listed)
- History of hip/pelvis, knee, or ankle surgery within the past year
- History of ankle fracture
- Diagnosis of a neurological disorder
- Presence of vestibular disorders
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 training groupNeurocognitive training is a rehabilitation approach that, unlike traditional treatment methods which primarily focus on improving physical performance, emphasizes cognitive functions and psychometric skills. It is a program developed by integrating motor learning strategies and cognitive challenges into neuromuscular training. These cognitive challenges include tasks requiring quick reactions, motor-motor or cognitive-motor tasks (dual-task), congruent and incongruent tasks, exercises involving mathematical calculations (working memory), and response inhibition tasks. | Other | Neurocognitive training group |
Primary outcome
Functional Ankle Instability Assessment Using the Identification of Functional Ankle Instability Questionnaire (IDFAI)
Time frame: from the beginning of the study until the end of the 4th week
The IDFAI is a self-reported questionnaire consisting of 9 items designed to identify the presence and severity of functional ankle instability. Scores range from 0 to 37, with higher scores indicating greater instability. A score above 11 suggests the presence of instability. Scores are unitless numeric values representing the severity of symptoms and frequency of ankle sprains.
Functional Ankle Instability Evaluation Using the Cumberland Ankle Instability Tool (CAIT)
Time frame: from the beginning of the study until the end of the 4th week
The CAIT is a self-assessment tool with 9 items measuring subjective ankle instability. Scores range from 0 (severe instability) to 30 (no instability). A score of 27 or below indicates functional ankle instability. The score is a unitless numeric value that reflects the level of perceived instability and risk of recurrent sprains.
Pain Severity Assessment-Visual Analog Scale (VAS)
Time frame: from the beginning of the study until the end of the 4th week
The Visual Analog Scale (VAS) is a 10 cm line ranging from "No pain" to "Worst imaginable pain." Participants mark their pain intensity on the line, which is measured in centimeters to quantify pain severity. This unitless numeric score reflects pain intensity at rest, during training, and post-training in ankles with instability history.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Results publication: PubMed 17379918Mohammadi F. Comparison of 3 preventive methods to reduce the recurrence of ankle inversion sprains in male soccer players. Am J Sports Med. 2007 Jun;35(6):922-6. doi: 10.1177/0363546507299259. Epub 2007 Mar 22.
- Results publication: PubMed 34153635Walker JM, Brunst CL, Chaput M, Wohl TR, Grooms DR. Integrating neurocognitive challenges into injury prevention training: A clinical commentary. Phys Ther Sport. 2021 Sep;51:8-16. doi: 10.1016/j.ptsp.2021.05.005. Epub 2021 May 19.
- Results publication18) Tekin E, Ünver F. Klinik Nörobilişsel Fonksiyonel Performans Testleri: Geleneksel Derleme. Turkiye Klinikleri Journal of Sports Sciences, 2023;15(2).
- Results publication: PubMed 30747379Tassignon B, Verschueren J, Delahunt E, Smith M, Vicenzino B, Verhagen E, Meeusen R. Criteria-Based Return to Sport Decision-Making Following Lateral Ankle Sprain Injury: a Systematic Review and Narrative Synthesis. Sports Med. 2019 Apr;49(4):601-619. doi: 10.1007/s40279-019-01071-3.
- Results publication: PubMed 33756239Verschueren J, Tassignon B, Verhagen E, Meeusen R. The interaction of acute physical fatigue with three traditional functional performance tests and the reactive balance test. Phys Ther Sport. 2021 May;49:188-195. doi: 10.1016/j.ptsp.2021.03.004. Epub 2021 Mar 17.
- Results publication: PubMed 22995264Simon J, Donahue M, Docherty C. Development of the Identification of Functional Ankle Instability (IdFAI). Foot Ankle Int. 2012 Sep;33(9):755-63. doi: 10.3113/FAI.2012.0755.
- Results publication: PubMed 21509114Plisky PJ, Gorman PP, Butler RJ, Kiesel KB, Underwood FB, Elkins B. The reliability of an instrumented device for measuring components of the star excursion balance test. N Am J Sports Phys Ther. 2009 May;4(2):92-9.
- Results publication13) Olsson L, Lund H, Henriksen M, Rogind H, Bliddal H, Danneskiold Samsøe B. Test-retest reliability of a knee joint position sense measurement method in sitting and prone position. Advances in Physiotherapy. 2004;6(1):37-47.
- Results publication: PubMed 35514277Obuz T, Topcu ZG. The effects of exercises with a Pilates ball on balance, reaction time and dual-task performance of kindergarten children. J Comp Eff Res. 2022 Jun;11(8):583-593. doi: 10.2217/cer-2021-0293. Epub 2022 May 6.
- Results publication: PubMed 32310156Loizidis T, Nikodelis T, Bakas E, Kollias I. The effects of dry needling on pain relief and functional balance in patients with sub-chronic low back pain. J Back Musculoskelet Rehabil. 2020;33(6):953-959. doi: 10.3233/BMR-181265.
- Results publication: PubMed 16935061Hiller CE, Refshauge KM, Bundy AC, Herbert RD, Kilbreath SL. The Cumberland ankle instability tool: a report of validity and reliability testing. Arch Phys Med Rehabil. 2006 Sep;87(9):1235-41. doi: 10.1016/j.apmr.2006.05.022.
- Results publication: PubMed 10840868Hertel J. Functional instability following lateral ankle sprain. Sports Med. 2000 May;29(5):361-71. doi: 10.2165/00007256-200029050-00005.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 training group in people with Chronic Ankle Instability and Balance, run by Balikesir University 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 4 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Ankle Instability Assessment Using the Identification of Functional Ankle Instability Questionnaire (IDFAI) (time frame: from the beginning of the study until the end of the 4th week). 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 NCT07004114, which also lists 19 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 4 Jun 2025.