- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Elif Aleyna Yazgan, Phd
- Número de teléfono: 000000000 000000000
- Correo electrónico: elifaleyna.yazgan@nisantasi.edu.tr
Ubicaciones de estudio
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Sarıyer
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Istanbul, Sarıyer, Turquía (Türkiye), 34453
- Reclutamiento
- Istanbul Nisantasi University
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Contacto:
- Elif Aleyna Yazgan, Phd
- Número de teléfono: 0000000000
- Correo electrónico: elifaleyna.yazgan@nisantasi.edu.tr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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
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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.
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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.
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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.
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Participants perform functional performance tests while receiving external focus of attention instructions directing attention toward movement outcomes and environmental targets during task execution.
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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
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Participants perform functional performance tests while simultaneously completing a cognitive task involving backward repetition of number sequences, increasing cognitive load during motor performance.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Dynamic Balance Performance
Periodo de tiempo: Day 1 (during the study assessment session)
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Dynamic balance performance assessed using the Y Balance Test under standard, internal focus of attention, external focus of attention, and cognitive dual-task conditions.
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Day 1 (during the study assessment session)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Vertical Jump Performance
Periodo de tiempo: Day 1 (during the study assessment session)
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Vertical jump height assessed using the My Jump 2 application under different neurocognitive testing conditions.
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Day 1 (during the study assessment session)
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Figure-of-8 Hop Performance
Periodo de tiempo: Day 1 (during the study assessment session)
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Figure-of-8 hop completion time assessed under different neurocognitive testing conditions.
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Day 1 (during the study assessment session)
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Dual-Task Cost
Periodo de tiempo: Day 1 (during the study assessment session)
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Dual-task cost calculated as the percentage change in motor performance between single-task and dual-task conditions.
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Day 1 (during the study assessment session)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- E-92045188-115.02-218837
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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