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Impact of Stroke Unit Care on Acute Stroke Outcomes

5 de agosto de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Tipo de estudo

Observacional

Inscrição (Estimado)

140

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

N/D

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
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.

Grupo / Coorte

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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Degree of Functional Dependence Using the Barthel Index Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Assiut University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

1 de setembro de 2027

Conclusão do estudo (Estimado)

1 de outubro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

1 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de agosto de 2026

Primeira postagem (Real)

6 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)