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Action Observation Therapy in Chronic Stroke Via Telerehabilitation

5 de junio de 2026 actualizado por: Mustafa Kavak, Karabuk University

Investigation of the Effect of Action Observation Therapy Via Telerehabilitation Method on Upper Extremity Functions, Daily Living Activities and Quality of Life in Chronic Stroke Patients

Stroke, a leading cause of disability worldwide, particularly affects upper extremity function, rendering individuals dependent on others for daily living activities and reducing their quality of life. To mitigate these effects, Action Observation Therapy (AOT), which has gained prominence in recent years, activates the mirror neuron system, triggering learning processes in the motor cortex and supporting functional recovery through the imitation of observed movements. Furthermore, telerehabilitation offers a significant advantage in facilitating access to rehabilitation services for these patients requiring long-term treatment, eliminating barriers such as transportation and cost. The absence of studies in the literature comparing the effectiveness of combining these two methods on hand skills and quality of life in individuals with chronic stroke with conventional physiotherapy makes investigating the clinical value of this approach academically unique and necessary.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Stroke is defined as a neurological condition caused by focal damage to the central nervous system due to vascular problems such as cerebral infarction, intracerebral or subarachnoid hemorrhage. Stroke is among the leading causes of death and disability worldwide.

Functional impairment in the upper extremities is frequently observed in stroke patients, significantly limiting their grasping and releasing functions, and consequently their daily living activities (ADL) such as eating, drinking, dressing, and self-care. Due to these limitations, stroke patients become dependent to varying degrees, negatively impacting their quality of life. Scientists are conducting various studies to find effective, low-cost, and easily applicable methods that can reduce the effects of stroke, which imposes a significant economic, physical, social, and psychological burden on patients and their families, and improve recovery.

Action Observation Therapy (AOT), which involves observing simple actions frequently used in ADL and then imitating those observed actions, is a rehabilitation approach applied in clinical settings in recent years to improve upper extremity function in the rehabilitation of stroke and various neurological diseases. The neural basis of AOT is the mirror neuron system, which is active not only when observing one's own movements but also when observing others' movements. Studies using Functional Magnetic Resonance Imaging have shown that mirror neuron activity increases when observing the movements of others. It is stated that observing an action and then trying to imitate it reduces interhemispheric inhibition, and as a result, it activates the primary motor cortex that causes the observed movement, facilitates the execution of the action, eliminates motor function disorders, and allows for the relearning of functions.

Telerehabilitation is the remote delivery of rehabilitation services through telecommunication technology. Telerehabilitation increases the accessibility of physiotherapy interventions in situations where face-to-face rehabilitation is not possible or difficult to access. In stroke patients with a lengthy rehabilitation process, telerehabilitation offers significant advantages, including reduced difficulties in transferring the patient to the healthcare center, shorter travel time, reduced transportation costs, and lower energy costs.

A literature review revealed no studies comparing the effects of AOT delivered via telerehabilitation on upper extremity function, hand skills, daily living activities, and quality of life in patients with chronic stroke compared with conventional physiotherapy.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

30

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

Ubicaciones de estudio

  • Turquía (Türkiye)
    • Merkez
      • Karabük, Merkez, Turquía (Türkiye), 78100
        • Reclutamiento
        • Karabuk University
        • Contacto:
      • Karabük, Merkez, Turquía (Türkiye), 78100
        • Reclutamiento
        • Mustafa KAVAK
        • Sub-Investigador:
          • Elif Ulukan, PT
        • Contacto:
        • Sub-Investigador:
          • Cihan Caner Aksoy, Assoc. Professor
        • Sub-Investigador:
          • Musa Güneş, Phd
        • Sub-Investigador:
          • İlker İlhanlı, Professor

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
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Being over 18 years of age,
  • Diagnosis of left hemiparetic stroke,
  • Having passed between 6 months since the onset of stroke,
  • Being in stage 4 or 5 of the hand and stage 4, 5 or 6 of the upper extremity according to Brunnstrom staging,
  • Being able to sit on a chair for 30 minutes without support (patients who scored 20 or more points in total from the Trunk Impairment Scale),
  • Scoring 24 or more points from the Mini Mental Test

Exclusion Criteria:

  • Unwillingness to participate in the study,
  • Having spasticity that prevents grasping and releasing an object (levels 3 and 4 on the Modified Ashworth Scale),
  • Having a contracture in any of the affected upper extremity joints,
  • Having severe neglect disorder (scoring 21 or higher on the Catherine Bergego Scale),
  • Having impaired cooperation, compliance, and behavior during the administration of tests used to obtain data,
  • Having a mental impairment that prevents communication and following basic commands (scoring less than 24 on the Mini-Mental Test),
  • Having additional neurological and/or orthopedic problems that may affect motor performance and sitting balance,
  • Having severe visual and hearing problems (if any, these problems not corrected with assistive devices such as glasses, contact lenses, hearing aids, etc.)

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: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Action observation Therapy
Participants will receive AOT via telerehabilitation in addition to conventional physiotherapy. They will receive 3 sessions per week for 5 weeks.
Otro: Conventional physiotherapy
All participants will receive conventional physiotherapy, including stretching, strengthening, core mobility, balance, electrotherapy, and endurance exercises in the clinic. These traditional sessions will be administered by physiotherapists three times a week, each lasting 45 minutes.
Sin intervención: control
Participants will receive only conventional physiotherapy. They will receive 3 sessions per week for 5 weeks.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Espasticidad
Periodo de tiempo: Base
La espasticidad se evaluará utilizando la escala de Ashworth modificada. A medida que aumenta la puntuación, aumenta la espasticidad. La puntuación mínima para esta escala es 1 y la puntuación máxima es 5.
Base
Etapa de hemiplejía
Periodo de tiempo: Base
La "estadificación de recuperación de hemiplegia de Brunnstrom" se utilizará para determinar la etapa hemiplegica de los pacientes. Esta escala se califica entre 1 y 6. A medida que aumenta la puntuación, el paciente mejora.
Base
Función cognitif
Periodo de tiempo: Base
La mini prueba mental se utilizará para evaluar las funciones cognitivas. En la evaluación, 24-30 puntos indican que las funciones cognitivas son normales, 18-23 puntos indican deterioro cognitivo leve y 17 puntos y debajo indican que el estado cognitivo se ve gravemente afectado.
Base
Descuido
Periodo de tiempo: Base
La escala de Catherine Bergego se utilizará para evaluar el impacto de la negligencia unilateral después del accidente cerebrovascular en las actividades de la vida diaria. 1-10 indica una negligencia leve, 11-20 indica una negligencia moderada y 21-30 indica una negligencia severa.
Base
Motor function
Periodo de tiempo: Baseline, five week later (after intervention)
The "Fugl-Meyer Upper Extremity Motor Assessment Scale" will be used to evaluate upper extremity motor functions. This scale ranges from 0 to 66 points. As the score increases, motor function improves.
Baseline, five week later (after intervention)
Life Quality
Periodo de tiempo: Baseline, five week later (after intervention)
The Stroke Specific Quality of Life Scale will be used to assess the quality of life of individuals with stroke. The higher the total score, the better the quality of life of the individual with stroke. This scale is scored between 49-245.As the score increases, the quality of life increases.
Baseline, five week later (after intervention)
Dominant side
Periodo de tiempo: Baseline
The "Edinburgh Hand Preference Test" will be used to determine the dominant side used by the patient in daily life. It will be used to determine which hand the patient uses more in daily life (Score range: -100 to +100; high positive scores indicate right-handedness, high negative scores indicate left-handedness).
Baseline
Upper extremity function
Periodo de tiempo: Baseline, five week later (after intervention)
Evaluation of upper extremity functions (hand-arm) and motor speed will be done with the "Nine-Hole Peg Test". It is a widely used clinical test that evaluates upper extremity function (hand and arm) and motor performance. The test consists of nine wooden sticks with a diameter of 9 millimeters (mm) and a standard wooden block with nine holes of 10 mm diameter. The patient inserts the nine sticks one by one into the nine holes as quickly as possible, placing them randomly into the holes, and then removes them one by one in the same manner. The timer is started when the first stick is inserted and stopped when the last stick is removed and released from the hand. The time taken for the patient to insert and remove the sticks is recorded. A shorter time indicates better upper extremity function.
Baseline, five week later (after intervention)
Functional Independence
Periodo de tiempo: Baseline, five week later (after intervention)
Evaluation of upper extremity functions will be done with the "Functional Independence Scale (FIS)". The is used to assess the change and development in ADL (Applications for Daily Living) depending on the degree of disability experienced by individuals and rehabilitation programs. Consisting of a total of 18 items, the FIS is divided into two main subcategories: motor domain (FIS-motor; 13 items) and cognitive domain (FIS-cognitive; 5 items). All activities are rated on a 7-point scale ranging from 1 (requires full assistance during activities) to 7 (performs the activity completely independently). The total FIS score ranges from 18 to 126 points. A decrease in the score indicates an increase in the individual's dependence during ADL.
Baseline, five week later (after intervention)

Colaboradores e Investigadores

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

Patrocinador

Karabuk University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

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)

15 de junio de 2026

Finalización primaria (Estimado)

1 de julio de 2026

Finalización del estudio (Estimado)

1 de octubre de 2026

Fechas de registro del estudio

Enviado por primera vez

1 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de junio de 2026

Publicado por primera vez (Actual)

5 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de junio de 2026

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

5 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Karabuk-02

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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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