The Effect of Home-Based Telerehabilitation in Individuals With Stroke
8 de octubre de 2021 actualizado por: Recep Ormen, Istanbul University - Cerrahpasa (IUC)
The Effect of Individualized Home-Based Telerehabilitation Intervention on Physical Parameters and Activities of Daily Living in Individuals With Stroke
Stroke is a clinical picture that develops due to occlusion or rupture of cerebral vessels and results in loss of cerebral functions. Stroke individuals face some limitations in managing daily activities such as walking, dressing, feeding and showering. Personal, environmental, and societal limitations have led to the development of new treatment strategies, such as telerehabilitation(TR), to meet the needs of stroke individuals and their caregivers.
In this study, patients will be randomized and divided into 2 groups in order to examine the effects of two different TR methods on physical parameters and activities of daily living in stroke patients. Baseline assessments will be made for both groups to determine functionality, activities of daily living, fall activity, quality of life, and level of fatigue. For 8 weeks, the TR group will do their exercises with exercise videos prepared on the system 3 times a week. The control group, on the other hand, will do their exercises with exercise brochures on the system 3 times a week for 8 weeks. After 8 weeks, assessments will be repeated. With telerehabilitation to be applied to individuals with stroke, it is aimed to increase functional capacity, independence in daily living activities and quality of life, and reduce the number of falls and fatigue levels.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
40
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: Recep Ormen, M.Sc
- Número de teléfono: +905316777334
- Correo electrónico: rormen@gmail.com
Ubicaciones de estudio
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Bakirkoy
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Istanbul, Bakirkoy, Pavo, 34100
- Reclutamiento
- Istanbul University-Cerrahpaşa
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Sub-Investigador:
- Yonca Zenginler Yazgan, PhD
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Contacto:
- Recep Ormen, M.Sc
- Número de teléfono: +905316777334
- Correo electrónico: rormen@gmail.com
-
-
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
25 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Diagnosed with stroke at least 1 year ago by a neurologist
- Modified Rankin score ≤3
- Have an internet infrastructure that can be accessed at home
- Not participated in a standardized physiotherapy program in the past 3 months
Exclusion Criteria:
- Presence of blurred or low vision problems
- Hearing and speech impairment at a level that will affect participation in the system
- Epilepsy
- Presence of pregnancy
- Having any cognitive problems that prevent using the system
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Telerehabilitation Group
This group will perform their exercises with pre-prepared personalized exercise videos over the telerehabilitation system 3 times a week for 8 weeks.
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Balance, walking, strengthening exercise videos etc. taken in different positions will be uploaded to the telerehabilitation system.
A personalized exercise program will be created from these exercises.
This program will be defined to the account of the patient and the follow-up of the person will be carried out through the system.
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Experimental: Control Group
This group will perform exercises with personalized exercise brochures defined over the telerehabilitation system 3 times a week for 8 weeks.
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Photos and explanations of exercises taken in different positions such as balance, walking, strengthening etc. will be uploaded to the telerehabilitation system.
A personalized exercise brochure will be created from these exercises.
This program will be defined for the patient's account and the patient will be asked to follow the exercises with this brochure.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Single Leg Stance Test (The change between the initial value and the value after 2 months will be evaluated)
Periodo de tiempo: Baseline and end of weeks 8
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It is a functional assessment test that measures the patient's standing balance on one leg.
It is applied for both legs of the patient with eyes open and closed.
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Baseline and end of weeks 8
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Five Times Sit to Stand Test (The change between the initial value and the value after 2 months will be evaluated)
Periodo de tiempo: Baseline and end of weeks 8
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This test assesses functional lower extremity strength, transfer, balance, and fall risk.
The time the patient sits and stands up from the chair 5 times is recorded.
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Baseline and end of weeks 8
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Romberg Test (The change between the initial value and the value after 2 months will be evaluated)
Periodo de tiempo: Baseline and end of weeks 8
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The patient's standing time is recorded in an upright position with her feet open at shoulder level and arms free at the side of the body, with her eyes open and then closed, without losing her balance.
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Baseline and end of weeks 8
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Independent Standing test (The change between the initial value and the value after 2 months will be evaluated)
Periodo de tiempo: Baseline and end of weeks 8
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It tests the patient's ability to stand in an upright position without any support or assistance, with her feet shoulder-width apart and arms free at the side of the body.
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Baseline and end of weeks 8
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Katz Index of Independence in Activities of Daily Living (The change between the initial value and the value after 2 months will be evaluated)
Periodo de tiempo: Baseline and end of weeks 8
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It is a scale that measures the patient's ability to perform activities of daily living independently and evaluates the functional status.
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Baseline and end of weeks 8
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Modified Falls Efficacy Scale (The change between the initial value and the value after 2 months will be evaluated)
Periodo de tiempo: Baseline and end of weeks 8
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It is a 14-item scale that measures the patient's confidence in falling.
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Baseline and end of weeks 8
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WHOQOL-BREF-TR (The change between the initial value and the value after 2 months will be evaluated)
Periodo de tiempo: Baseline and end of weeks 8
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It is a health-related quality of life scale developed by the World Health Organization.
A national question was added to the Turkish version of the scale in addition to the original version.
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Baseline and end of weeks 8
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Fatigue Severity Scale (The change between the initial value and the value after 2 months will be evaluated)
Periodo de tiempo: Baseline and end of weeks 8
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It is a scale that evaluates the severity of fatigue with 9 items that patients can answer on their own.
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Baseline and end of weeks 8
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Global Rating of Change Scales
Periodo de tiempo: End of weeks 8
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It is a scale that evaluates how much the patient's current condition has changed compared to previous condition.
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End of weeks 8
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System Usability Scale
Periodo de tiempo: End of weeks 8
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It is a scale consisting of 10 questions widely used in the literature to evaluate the perceptibility and usability of interactive systems.
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End of weeks 8
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Yonca Zenginler Yazgan, PhD, Istanbul University-Cerrahpasa Faculty of Health Science
- Investigador principal: Recep Ormen, M.Sc, Istanbul University-Cerrahpasa Institute of Postgraduate Education
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 (Actual)
4 de octubre de 2021
Finalización primaria (Anticipado)
4 de agosto de 2022
Finalización del estudio (Anticipado)
28 de diciembre de 2022
Fechas de registro del estudio
Enviado por primera vez
8 de octubre de 2021
Primero enviado que cumplió con los criterios de control de calidad
8 de octubre de 2021
Publicado por primera vez (Actual)
19 de octubre de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de octubre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
8 de octubre de 2021
Última verificación
1 de octubre de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IUC-2021/62
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
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