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临床试验/NCT07750860
NCT07750860尚未招募不适用

Impact of Stroke Unit Care on Outcome of Acute Stroke Patients

Assiut University0 个研究点目标入组 140 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
140
主要终点
Degree of Functional Dependence Using the Barthel Index

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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 >
  • 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.

研究组 & 干预措施

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.

结局指标

主要结局

Degree of Functional Dependence Using the Barthel Index

时间窗: 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)

Degree of Functional Dependence Using the Barthel Index

时间窗: 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)

Degree of Functional Dependence Using the Barthel Index

时间窗: 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)

Degree of Functional Dependence Using the Barthel Index

时间窗: 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)

Degree of Functional Dependence Using the Barthel Index

时间窗: 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)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rania Hussein Ibrahim Mohammed

Resident of Neurology and Psychiatry

Assiut University

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