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Impact of Stroke Unit Care on Acute Stroke Outcomes

2026년 8월 5일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

연구 유형

관찰

등록 (추정된)

140

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

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샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Degree of Functional Dependence Using the Barthel Index
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 9월 1일

연구 완료 (추정된)

2027년 10월 1일

연구 등록 날짜

최초 제출

2026년 8월 1일

QC 기준을 충족하는 최초 제출

2026년 8월 5일

처음 게시됨 (실제)

2026년 8월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 5일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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