Impact of Stroke Unit Care on Acute Stroke Outcomes

NCT07750860 | Not Yet Recruiting

• 1 other identifier: Acute Stroke Unit Outcomes
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Stroke; Ischemic Stroke; Hemorrhagic Stroke

Keywords

Stroke Unit; Functional Outcome; Modified Rankin Scale (mRS); Barthel Index; National Institutes of Health Stroke Scale (NIHSS); Montreal Cognitive Assessment (MoCA)

Outcome Measures

Primary Outcomes (5)

• Degree of Functional Dependence Using the Barthel Index

  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

  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

  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

  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

  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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Neurology and Psychiatry

Study Record Dates

• First Submitted: August 1, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08