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Effects of Cervical and Oculomotor Exercises on Functional Status, Balance, and Proprioception in Chronic Ankle Instability

4 de junio de 2026 actualizado por: Simge Nur UNGAN, Izmir Katip Celebi University

Effects of Cervical and Oculomotor Exercises Added to Conventional Treatment on Ankle Functional Status, Balance, and Proprioception in Individuals With Chronic Ankle Instability: A Randomized Controlled Trial

Effects of Cervical and Oculomotor Exercises on Functional Status, Balance, and Proprioception in Chronic Ankle Instability

Descripción general del estudio

Estado

Reclutamiento

Intervención / Tratamiento

Descripción detallada

Effects of Cervical and Oculomotor Exercises Added to Conventional Treatment on Ankle Functional Status, Balance, and Proprioception in Individuals with Chronic Ankle Instability: A Randomized Controlled Trial

Tipo de estudio

Intervencionista

Inscripción (Estimado)

38

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Simge N UNGAN, Phsiotherapist
  • Número de teléfono: +90 507 648 5776
  • Correo electrónico: ungansimgenur@gmail.com

Ubicaciones de estudio

    • Çiğli
      • Izmir, Çiğli, Turquía (Türkiye), 35650
        • Reclutamiento
        • Izmir Katip Celebi University Physiotherapy and Rehabilitation Department
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Diagnosed with unilateral chronic ankle instability (CAI) in accordance with the International Ankle Consortium recommendations
  • A history of at least one significant lateral ankle sprain that occurred at least 12 months prior to participation, resulting in inflammatory symptoms such as pain and swelling and causing at least one day of interruption in physical activity
  • A history of "giving way" and/or recurrent ankle sprains and/or a feeling of instability in the affected ankle within the past 6 months
  • A Cumberland Ankle Instability Tool (CAIT) score of ≤ 25

Exclusion Criteria:

  • History of surgery or fracture in the lower extremities or spine
  • Acute musculoskeletal injury affecting other joints of the lower extremity within the past 3 months (e.g., sprains, fractures) that impaired joint integrity and function and caused at least one day of interruption in physical activity
  • History of injection in the affected ankle
  • History of ankle sprain in the affected extremity within the past 4 weeks
  • Presence of systemic musculoskeletal disorders, neurological disorders, vestibular disorders, or any other condition that may affect balance or sensory function
  • Previous participation in any rehabilitation program for the ankle or cervical region
  • History of head or neck trauma or diagnosed pathology within the past 12 months
  • History of neck pain greater than 3/10 in severity within the past 12 months

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Conventional Treatment + Cervical and Oculomotor Exercises
Participants in the experimental group will receive a conventional rehabilitation program including mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint. In addition, they will perform cervical stabilization and oculomotor exercises. The intervention will be conducted for 4 weeks, with 3 sessions per week. Participants will follow a home exercise program that includes ankle mobility, strengthening, balance, and oculomotor exercises on days when they do not attend the clinic.
Participants in the experimental group will receive a conventional rehabilitation program including mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint. In addition, they will perform cervical stabilization and oculomotor exercises.
Participants in the control group will receive a conventional rehabilitation program including mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint.
Comparador activo: Conventional Treatment
Participants in the control group will receive a conventional rehabilitation program consisting of mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint. The intervention will be conducted for 4 weeks, with 3 sessions per week. Participants will follow a home exercise program that includes ankle mobility, strengthening and balance exercises on days when they do not attend the clinic.
Participants in the experimental group will receive a conventional rehabilitation program including mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint. In addition, they will perform cervical stabilization and oculomotor exercises.
Participants in the control group will receive a conventional rehabilitation program including mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Y-Balance Test
Periodo de tiempo: Baseline and post-intervention (after 4 weeks)
Dynamic balance performance assessed using balance tests (Y-Balance Test)
Baseline and post-intervention (after 4 weeks)
Foot and Ankle Ability Measure (FAAM)
Periodo de tiempo: Baseline and post-intervention (after 4 weeks)
Functional status assessed using the Foot and Ankle Ability Measure (FAAM) The daily living activities subscale contains 21 items; the minimum score is 0 and the maximum score is 84. The sports subscale consists of 8 items; the minimum score is 0 and the maximum score is 32. A higher score represents a higher level of physical function.
Baseline and post-intervention (after 4 weeks)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Ankle Joint Position Error Test
Periodo de tiempo: Baseline and post-intervention (after 4 weeks)
Ankle proprioception assessed using laser beam device joint position error (JPE) tests
Baseline and post-intervention (after 4 weeks)
Weight Bearing Lunge Test
Periodo de tiempo: Baseline and post-intervention (after 4 weeks)
Ankle dorsiflexion range of motion will be assessed with the weight bearing lunge test
Baseline and post-intervention (after 4 weeks)
Computerized balance assessment
Periodo de tiempo: Baseline and post-intervention (after 4 weeks)
Postural stability will be assessed using the Prokin Tecnobody balance assessment system.
Baseline and post-intervention (after 4 weeks)
Side Hop Test
Periodo de tiempo: Baseline and post-intervention (after 4 weeks)
Side hop test will be used to assess the dynamic postural control capacity around the ankle.
Baseline and post-intervention (after 4 weeks)
Ankle Pain
Periodo de tiempo: Baseline and post-intervention (after 4 weeks)
Ankle pain will be assessed using a visual analog scale (VAS). The VAS is a scale ranging from 0 (no pain) to 10 (most severe pain), with higher scores indicating greater pain.
Baseline and post-intervention (after 4 weeks)
Cervical Joint Position Error Test
Periodo de tiempo: Baseline and post-intervention (after 4 weeks)
Cervical proprioception will be assessed using the Cervical Joint Position Error Test.
Baseline and post-intervention (after 4 weeks)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Silla de estudio: Damla KARABAY, Assistant Professor, Izmir Katip Celebi University
  • Investigador principal: Simge N UNGAN, Physiotherapist (Bachelor), Izmir Katip Celebi University
  • Director de estudio: Sercan Çapkın, Associate Professor, İzmir Bakırçay University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

7 de junio de 2026

Finalización primaria (Estimado)

7 de junio de 2027

Finalización del estudio (Estimado)

7 de junio de 2027

Fechas de registro del estudio

Enviado por primera vez

29 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de mayo de 2026

Publicado por primera vez (Actual)

12 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

A final decision regarding the sharing of individual participant data has not yet been made due to considerations related to data protection regulations. If a decision to share is made in the future, only de-identified data relevant to the published results may be shared upon reasonable request and in accordance with applicable regulations.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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