- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07750860
Impact of Stroke Unit Care on Acute Stroke Outcomes
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of Functional Dependence Using the Barthel Index
Time Frame: 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)
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Baseline (on admission)
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Degree of Functional Dependence Using the Barthel Index
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Acute Stroke Unit Outcomes
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