Clinical trial NCT06811350: Quality Improvement Initiative for Enhancing Early Mobilization in Intracerebral Hemorrhage Patients
Official title: Quality Improvement Initiative for Enhancing Early Mobilization in Intracerebral Hemorrhage Patients: Pre-Post Implementation of a Structured Clinical Pathway
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Primary Intracerebral Hemorrhage
Early Mobilization
Keywords: Intracerebral hemorrhage
Early mobilization
Stroke unit
Clinical pathway
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary intracerebral hemorrhage (ICH), a severe and life-threatening condition characterized by bleeding within the brain, carries a high mortality rate of up to 50% within the first month. Survivors of ICH are at significant risk of long-term disability due to the extensive damage caused by the hemorrhage

Brief summary: Primary intracerebral hemorrhage (ICH) is a severe and life-threatening condition with a high mortality rate, reaching up to 50% within the first month. Survivors are often at risk of long-term disability due to the extensive brain damage caused by the hemorrhage. Unlike ischemic stroke patients, ICH patients are typically younger, face longer hospital stays, and are more likely to experience acute complications. Modern treatment approaches have shifted from focusing solely on reducing mortality to minimizing disability and enhancing functional outcomes through early rehabilitation. However, the optimal timing and intensity of early mobilization remain unclear, especially for patients with severe ICH, where medical stability is a major concern. Delays in initiating rehabilitation may limit neuroplasticity and hinder recovery, prompting the need for a structured, multidisciplinary approach to early mobilization in ICH patients.

Objective : This quality improvement (QI) initiative aimed to enhance early mobilization in ICH patients by implementing a structured clinical pathway in an academic stroke center. The goal was to integrate evidence-based early mobilization pathways to improve patient mobility outcomes while ensuring safety through standardized assessments of cardiovascular, respiratory, and neurological stability.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of primary ICH
* ICH score from 0 to 4
* Patients In line with the stroke center's standard criteria for early rehabilitation

Exclusion Criteria:

* Patients with traumatic brain injury, hemorrhagic transformation of ischemic stroke, or hemorrhage related to underlying malignancy
* Patients placed in palliative care or those who died before initial hospital discharge

Primary outcomes:
measure: Modified ICU mobility scale
timeFrame: through study completion, an average of 12 weeks
Secondary outcomes:
measure: the time to first mobilization
timeFrame: Through study completion, an average of 12 weeks
measure: National Institutes of Health Stroke Scale (NIHSS) score
timeFrame: through study completion, an average of 12 weeks
measure: Modified Rankin Scale (mRS)
timeFrame: through study completion, an average of 12 weeks
measure: Duration of ICU and hospital stays
timeFrame: Through study completion, an average of 12 weeks
measure: ability to ambulate upon discharge
timeFrame: through study completion, an average of 12 weeks
Other outcomes:
Locations:
city: Tiapei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: