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- Ensayo clínico NCT04821518
The Use of Samsung Health and ECG M-Trace Base II Applications in the Secondary Prevention After Stroke
The Use of Samsung Health and ECG M-Trace Base II Applications for the Assessment of Exercise Tolerance as the Secondary Prevention in Patients After Brain Stroke
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Poznań, Polonia, 61-545
- Department of Rehabilitation and Physiotherapy Rehabilitation,
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
The study group (post-stroke) consisted of 26 patients (mean age 54.9±7.1) in whom ischaemic stroke occurred within 14 days before the admission to the Clinical Department.
The control group was composed of 26 healthy (mean age 55.6±6.1) individuals recruited from the hospital staff who did not experience stroke.
Descripción
Inclusion criteria to the post-stroke group were as follows :
- occurrence of hemiparesis after the first episode of ischaemic stroke
- stroke confirmed in the diagnostic imaging records
- score >3 on Lovett's scale of muscle strength in the paretic limbs
- score above 15 in Barthel's scale of performance in activities of daily living
- score below 12 in the National Institutes of Health Stroke Scale (NIHSS)
- available complete medical records concerning the assessed risk factors of recurrent CVD event
- lack of concomitant pulmonary diseases including chronic obstructive pulmonary disease and bronchial asthma
Exclusion criteria from the post-stroke group were as follows:
- hemiparesis or tetraparesis following many episodes of stroke,
- lack of diagnostic imaging scans confirming the occurrence of stroke
- hospital stay at the Department of Neurological Rehabilitation for more than 14 days from the occurrence of stroke
- incomplete medical records concerning the assessed risk factors of recurrent CVD event
- score >3 on Lovett's scale of muscle strength in the paretic limbs
- score below 14 in Barthel's scale of performance in activities of daily living
- score above 13 in the NIHSS scale
- occurrence of factors limiting walking ability, such as diagnosed pulmonary diseases, unstable angina, severe valvular heart diseases, cardiomyopathy, musculoskeletal or autoimmune diseases.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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The study group (post-stroke)
The study group consisted of 26 patients in whom ischaemic brain stroke occurred within 14 days before the admission to the Clinical Department, and were hospitalised at the Department of Neurological Rehabilitation of the Clinical Department of Rehabilitation in the Wiktor Dega Orthopaedic and Rehabilitation Clinical Hospital in Poznań
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The control group
The control group was composed of 26 healthy individuals recruited from the hospital staff who did not experience stroke.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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heart rate at rest
Periodo de tiempo: baseline
|
heart rate per minute
|
baseline
|
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heart rate at rest
Periodo de tiempo: 3 weeks
|
heart rate per minute
|
3 weeks
|
|
heart rate after SMWT
Periodo de tiempo: baseline
|
heart rate per minute
|
baseline
|
|
heart rate after SMWT
Periodo de tiempo: 3 weeks
|
heart rate per minute
|
3 weeks
|
|
heart rate after SCT
Periodo de tiempo: baseline
|
heart rate per minute
|
baseline
|
|
heart rate after SCT
Periodo de tiempo: 3 weeks
|
heart rate per minute
|
3 weeks
|
|
heart rhythm at rest
Periodo de tiempo: baseline
|
heart rhythm interpreting ECG (regular or irregular)
|
baseline
|
|
heart rhythm at rest
Periodo de tiempo: 3 weeks
|
heart rhythm interpreting ECG (regular or irregular)
|
3 weeks
|
|
heart rhythm after SMWT
Periodo de tiempo: baseline
|
heart rhythm interpreting ECG (regular or irregular)
|
baseline
|
|
heart rhythm after SMWT
Periodo de tiempo: 3 weeks
|
heart rhythm interpreting ECG (regular or irregular)
|
3 weeks
|
|
heart rhythm after SCT
Periodo de tiempo: baseline
|
heart rhythm interpreting ECG (regular or irregular)
|
baseline
|
|
heart rhythm after SCT
Periodo de tiempo: 3 weeks
|
heart rhythm interpreting ECG (regular or irregular)
|
3 weeks
|
|
increased blood pressure at rest
Periodo de tiempo: baseline
|
blood pressure value [mm/Hg]
|
baseline
|
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increased blood pressure at rest
Periodo de tiempo: 3 weeks
|
blood pressure value [mm/Hg]
|
3 weeks
|
|
increased blood pressure after SMWT
Periodo de tiempo: baseline
|
blood pressure value [mm/Hg]
|
baseline
|
|
increased blood pressure after SMWT
Periodo de tiempo: 3 weeks
|
blood pressure value [mm/Hg]
|
3 weeks
|
|
increased blood pressure after SCT
Periodo de tiempo: baseline
|
blood pressure value [mm/Hg]
|
baseline
|
|
increased blood pressure after SCT
Periodo de tiempo: 3 weeks
|
blood pressure value [mm/Hg]
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3 weeks
|
|
Distance of walk after SMWT
Periodo de tiempo: baseline
|
Distance (metres)
|
baseline
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Distance of walk after SMWT
Periodo de tiempo: 3 weeks
|
Distance (metres)
|
3 weeks
|
|
Distance of walk after SCT
Periodo de tiempo: baseline
|
Distance (metres)
|
baseline
|
|
Distance of walk after SCT
Periodo de tiempo: 3 weeks
|
Distance (metres)
|
3 weeks
|
|
Steps after SMWT
Periodo de tiempo: baseline
|
Number of steps (number)
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baseline
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Steps after SMWT
Periodo de tiempo: 3 weeks
|
Number of steps (number)
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3 weeks
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Steps after SCT
Periodo de tiempo: baseline
|
Number of steps (number)
|
baseline
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Steps after SCT
Periodo de tiempo: 3 weeks
|
Number of steps (number)
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3 weeks
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|
Velocity of walk after SMWT
Periodo de tiempo: baseline
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Mean velocity (km/h)
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baseline
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Velocity of walk after SMWT
Periodo de tiempo: 3 weeks
|
Mean velocity (km/h)
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3 weeks
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Velocity of walk after SCT
Periodo de tiempo: baseline
|
Mean velocity (km/h)
|
baseline
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Velocity of walk after SCT
Periodo de tiempo: 3 weeks
|
Mean velocity (km/h)
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3 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ewa Chlebuś, Clinic Rehabilitation, University of Medical Sciences in Poznań
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1/2021
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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