Acute StrokeNCT07750860
Impact of Stroke Unit Care on Acute Stroke Outcomes
An observational study of Acute Stroke and Ischemic Stroke, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke, Ischemic Stroke, Hemorrhagic Stroke
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Oct 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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:
Read more
- 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)
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 3 month post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Hussein Ibrahim Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750860
- Sponsor's protocol ID
- Acute Stroke Unit Outcomes
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2026
- Last updated
- 6 Aug 2026
- Results posted
- No