- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07689747
Neurocognitive Enrichment During Functional Performance Testing in Chronic Ankle Instability
Acute Effects of Neurocognitively Enriched Functional Performance Testing Conditions on Balance and Functional Performance in Athletes With Chronic Ankle Instability: A Randomized Crossover Study
Chronic ankle instability (CAI) is associated with recurrent ankle sprains, impaired postural control, and reduced functional performance. Traditional functional performance tests are commonly used to assess athletes with CAI; however, these assessments are typically conducted under isolated motor conditions and may not adequately reflect the neurocognitive demands encountered during sports participation.
The aim of this randomized crossover study is to investigate the acute effects of neurocognitively enriched testing conditions on balance and functional performance in athletes with CAI. Participants will perform functional performance tests under four different conditions: standard testing, internal focus of attention, external focus of attention, and cognitive dual-task conditions. Dynamic balance, vertical jump performance, single-leg hop performance, figure-of-8 hop performance, and dual-task cost will be assessed and compared across conditions.
The findings of this study may contribute to the development of more ecologically valid assessment approaches for athletes with CAI and provide insights into the influence of attentional focus and cognitive load on functional performance.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Chronic ankle instability (CAI) is a common consequence of lateral ankle sprains and is characterized by recurrent episodes of giving way, repeated sprains, impaired sensorimotor control, and persistent functional limitations. Although functional performance tests are widely used to assess readiness for sports participation and return-to-sport status, these assessments are typically performed under isolated motor conditions and may not adequately represent the complex neurocognitive demands encountered during athletic activities.
Recent evidence from motor learning and sports medicine literature suggests that attentional focus strategies and cognitive loading can substantially influence movement performance, postural control, and motor execution. Internal focus of attention directs individuals toward body movements and joint positions, whereas external focus of attention emphasizes movement outcomes and environmental effects. In addition, dual-task paradigms introduce cognitive demands that may alter motor performance by increasing attentional load and competing for cognitive resources. Understanding how these neurocognitive factors influence functional performance may provide valuable information for the assessment and management of athletes with CAI.
The present study aims to examine the acute effects of neurocognitively enriched testing conditions on balance and functional performance in athletes with CAI. By comparing performance under standard testing, internal focus, external focus, and cognitive dual-task conditions, the study seeks to determine whether commonly used functional performance tests are sensitive to variations in attentional focus and cognitive load.
This investigation is expected to contribute to a better understanding of the interaction between cognitive processes and motor performance in athletes with CAI. The findings may support the development of more ecologically valid assessment strategies and provide clinically relevant information for rehabilitation planning, functional evaluation, and return-to-sport decision-making in athletic populations with chronic ankle instability.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Elif Aleyna Yazgan, Phd
- Telefonnummer: 000000000 000000000
- E-Mail: elifaleyna.yazgan@nisantasi.edu.tr
Studienorte
-
-
Sarıyer
-
Istanbul, Sarıyer, Türkei (türkiye), 34453
- Rekrutierung
- Istanbul Nisantasi University
-
Kontakt:
- Elif Aleyna Yazgan, Phd
- Telefonnummer: 0000000000
- E-Mail: elifaleyna.yazgan@nisantasi.edu.tr
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Aged between 16 and 25 years.
- Actively participating as a licensed football, basketball, or volleyball athlete.
- History of at least one lateral ankle sprain occurring ≥12 months before study participation, associated with pain and/or swelling and resulting in at least one day of restricted physical activity.
- History of recurrent ankle instability, defined as at least two episodes of giving way during the previous 6 months and/or recurrent ankle sprains.
- Cumberland Ankle Instability Tool (CAIT) score ≤25.
- Participating in regular sports training at least 3 times per week.
- No ankle surgery within the previous 6 months.
- Able to safely perform all functional performance tests.
- Willing to undergo assessment of the more symptomatic ankle; in participants with bilateral chronic ankle instability, the ankle with the lower CAIT score will be evaluated.
Exclusion Criteria:
- Acute ankle sprain within the previous 6 weeks accompanied by significant pain, swelling, or functional limitation.
- History of major lower-extremity surgery (e.g., knee, hip, or ankle surgery).
- History of neurological, vestibular, or systemic disorders that may affect balance or motor performance.
- Visual or cognitive impairments that could interfere with test performance.
- Lower-extremity injuries other than ankle instability within the previous 6 months that may negatively affect functional performance.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Screening
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Standard Testing Condition
Participants perform all functional performance tests under standard testing conditions without attentional focus instructions or additional cognitive tasks.
This condition serves as the reference condition for comparison with neurocognitively enriched testing conditions.
|
Participants perform functional performance tests under standard testing conditions without attentional focus instructions or additional cognitive tasks.
This condition serves as the reference condition for comparison with neurocognitively enriched testing conditions
|
|
Experimental: Internal Focus of Attention Condition
Participants perform all functional performance tests while receiving internal focus of attention instructions directing attention toward body movements, joint positions, and movement control.
|
Participants perform functional performance tests while receiving internal focus of attention instructions directing attention toward body movements, joint positions, and movement control during task execution.
|
|
Experimental: External Focus of Attention Condition
Participants perform all functional performance tests while receiving external focus of attention instructions directing attention toward movement outcomes and environmental targets.
|
Participants perform functional performance tests while receiving external focus of attention instructions directing attention toward movement outcomes and environmental targets during task execution.
|
|
Experimental: Cognitive Dual-Task Condition
Participants perform all functional performance tests while simultaneously completing a cognitive task involving backward repetition of number sequences to increase cognitive load
|
Participants perform functional performance tests while simultaneously completing a cognitive task involving backward repetition of number sequences, increasing cognitive load during motor performance.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Dynamic Balance Performance
Zeitfenster: Day 1 (during the study assessment session)
|
Dynamic balance performance assessed using the Y Balance Test under standard, internal focus of attention, external focus of attention, and cognitive dual-task conditions.
|
Day 1 (during the study assessment session)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Vertical Jump Performance
Zeitfenster: Day 1 (during the study assessment session)
|
Vertical jump height assessed using the My Jump 2 application under different neurocognitive testing conditions.
|
Day 1 (during the study assessment session)
|
|
Figure-of-8 Hop Performance
Zeitfenster: Day 1 (during the study assessment session)
|
Figure-of-8 hop completion time assessed under different neurocognitive testing conditions.
|
Day 1 (during the study assessment session)
|
|
Dual-Task Cost
Zeitfenster: Day 1 (during the study assessment session)
|
Dual-task cost calculated as the percentage change in motor performance between single-task and dual-task conditions.
|
Day 1 (during the study assessment session)
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- E-92045188-115.02-218837
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Standard Testing Condition
-
Istituto Clinico HumanitasBioMérieuxRekrutierungBlutbahninfektion | Gram-positive Infektionen | Bakteriämie Sepsis | Gramnegative InfektionenItalien
-
Central Denmark RegionRekrutierungPoint-of-Care-Tests | Medizinischer Notfalldienst vor dem Krankenhaus | Präklinische NotfallversorgungDänemark
-
Washington University School of MedicineThe Foundation for Barnes-Jewish HospitalBeendetLynch-Syndrom | Erblicher Brust- und EierstockkrebsVereinigte Staaten
-
Xspray Pharma ABAbgeschlossen
-
Eastern Hepatobiliary Surgery HospitalNoch keine RekrutierungFortgeschrittener Gallengangskrebs (BTC)
-
Wake Forest University Health SciencesAbgeschlossen
-
US Department of Veterans AffairsAbgeschlossen
-
University of PittsburghNational Institute of Nursing Research (NINR); National Institute on Aging (NIA)AbgeschlossenDemenz | Alzheimer ErkrankungVereinigte Staaten
-
University of PittsburghNational Institute on Deafness and Other Communication Disorders (NIDCD); University...RekrutierungStreicheln | AphasieVereinigte Staaten
-
Northwell HealthGenomind, LLCAbgeschlossenPsychotische Störungen | Schizophrenie | Schizoaffektiven Störung | Schizophreniforme Störung | Bipolare StörungVereinigte Staaten