Impact of Stroke Unit Care on Acute Stroke Outcomes
5 de agosto de 2026 actualizado por: Rania Hussein Ibrahim Mohammed, Assiut University
Impact of Stroke Unit Care on Outcome of Acute Stroke Patients
This observational study is designed to evaluate and compare the recovery outcomes of patients who have experienced their first acute stroke. Specifically, it looks at how receiving care in a specialized Stroke Unit compares to receiving care in a conventional hospital neurology ward.
Researchers will observe 140 adult patients admitted to Assiut University Hospital within 48 hours of their stroke symptoms starting. Patients will be observed in two distinct groups of 70 based on their admission setting:
- Stroke Unit Care: Patients in this group receive care from a specialized, multi-professional team (including vascular neurologists, stroke nurses, neuro-physiotherapists, and clinical pharmacists). They undergo continuous heart and vital sign monitoring for the first 24 to 48 hours, participate in early physical activity protocols, and follow strict guidelines for swallowing checks, temperature control, and blood sugar management.
- Conventional Ward Care: Patients in this group receive standard medical care and general nursing management. Their vital signs are checked during routine shifts, and physical therapy is provided only when specifically requested on a case-by-case basis.
The study will track the patients' progress by measuring their independence in daily activities, physical disability levels, and cognitive (thinking) skills. Assessments will happen when they are discharged from the hospital, and then again at 2 weeks, 1 month, 2 months, and 3 months after they go home to evaluate their overall recovery, complications, and mortality rates.
Descripción general del estudio
Estado
Aún no reclutando
Tipo de estudio
De observación
Inscripción (Estimado)
140
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
N/A
Método de muestreo
Muestra no probabilística
Población de estudio
The study population consists of adult patients (aged 18 years and older) who present with an acute, first-ever stroke (either ischemic or hemorrhagic).
Patients must be admitted to the hospital within 48 hours of their initial symptom onset.
The population will be recruited from admissions to either the general Neurology inpatient wards or the specialized Stroke Unit within the Neurology and Psychiatry, and Neurosurgery departments at Assiut University Hospital over a 6-month duration.
Descripción
Inclusion Criteria:
- Patients aged ≥ 18 years at the time of presentation.
- Confirmed clinical diagnosis of acute first ever stroke (either ischemic or hemorrhagic) supported by objective neuroimaging findings via history case taking and emergency CT or MRI scans.
- Hospital admission initiated within 48 hours of initial symptom onset.
- Informed consent provided, signed, and dated by the patient or a legally authorized proxy representative.
Exclusion Criteria:
- Diagnosis of a Transient Ischemic Attack (TIA) or presenting stroke mimics (e.g., complex migraines, severe hypoglycemia, conversion disorders, status epilepticus).
- Pre-existing severe functional disability prior to the index stroke event, established as a baseline pre-stroke Modified Rankin Scale (mRS) score > 2.
- Co-morbid advanced or terminal medical or neurological or psychiatric conditions with a documented clinical life expectancy of less than 6 months.
- Incomplete medical charts, structural data gaps, or formal withdrawal on baseline assessment or on hospital stay assessment before discharge.
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
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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Dedicated Stroke Unit (SU) Care
Patients admitted to the stroke unit for acute stroke management.
Core interventions include care managed by a specialized multi-professional team consisting of vascular neurologists, specialized stroke nurses, neuro-physiotherapists, and clinical pharmacists.
Care also involves continuous non-invasive cardiac, telemetry, and hemodynamic tracking for at least the initial 24-48 hours, evidence-based early mobilization protocols, and standardized integrated clinical pathways focusing on early dysphagia screening, rapid glycemic control, and strict normothermia management.
|
|
Conventional Ward Care
Patients confirmed to have an acute stroke who are admitted directly to neurology wards for acute stroke management.
Care components include standard medical workup, generalized nursing management, and intermittent monitoring of vital signs dictated by routine ward shift protocols.
On-call or scheduled consultations from physical therapy are requested on an ad-hoc, case-by-case basis.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Degree of Functional Dependence Using the Barthel Index
Periodo de tiempo: Baseline (on admission)
|
The Barthel Index measures a patient's degree of independence in daily activity performance.
Possible scores range from 0 to 100, with higher scores indicating a higher degree of independence (better outcome)
|
Baseline (on admission)
|
|
Degree of Functional Dependence Using the Barthel Index
Periodo de tiempo: 2 weeks post-discharge
|
The Barthel Index measures a patient's degree of independence in daily activity performance.
Possible scores range from 0 to 100, with higher scores indicating a higher degree of independence (better outcome)
|
2 weeks post-discharge
|
|
Degree of Functional Dependence Using the Barthel Index
Periodo de tiempo: 1 month post-discharge
|
The Barthel Index measures a patient's degree of independence in daily activity performance.
Possible scores range from 0 to 100, with higher scores indicating a higher degree of independence (better outcome)
|
1 month post-discharge
|
|
Degree of Functional Dependence Using the Barthel Index
Periodo de tiempo: 2 month post-discharge
|
The Barthel Index measures a patient's degree of independence in daily activity performance.
Possible scores range from 0 to 100, with higher scores indicating a higher degree of independence (better outcome)
|
2 month post-discharge
|
|
Degree of Functional Dependence Using the Barthel Index
Periodo de tiempo: 3 month post-discharge
|
The Barthel Index measures a patient's degree of independence in daily activity performance.
Possible scores range from 0 to 100, with higher scores indicating a higher degree of independence (better outcome)
|
3 month post-discharge
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de septiembre de 2027
Finalización del estudio (Estimado)
1 de octubre de 2027
Fechas de registro del estudio
Enviado por primera vez
1 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de agosto de 2026
Publicado por primera vez (Actual)
6 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
5 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Acute Stroke Unit Outcomes
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