- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06811350
Quality Improvement Initiative for Enhancing Early Mobilization in Intracerebral Hemorrhage Patients
Quality Improvement Initiative for Enhancing Early Mobilization in Intracerebral Hemorrhage Patients: Pre-Post Implementation of a Structured Clinical Pathway
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Tiapei, Taiwan, 100
- National Taiwan University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
pre-implementation cohort
Patients received conventional care without a structured mobility pathway, with mobilization decisions made at the discretion of the attending physician and rehabilitation team.
|
Patients recieved a structured early mobilization pathway was introduced.
The pathway included standardized assessments for patient stability and phased rehabilitation, progressing from passive to active mobilization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified ICU mobility scale
Time Frame: through study completion, an average of 12 weeks
|
The Modified ICU Mobility Scale is used to assess the level of mobility in ICU patients, with scores ranging from 0 to 10.
A higher score indicates better mobility, where 0 represents no mobility (lying in bed, passive movements only), and 10 indicates independent ambulation without assistance.
|
through study completion, an average of 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the time to first mobilization
Time Frame: Through study completion, an average of 12 weeks
|
The time to first mobilization (in hours or days) will be assessed from hospital admission to the first documented mobilization event, measured through study completion, with an average follow-up period of 12 weeks.
|
Through study completion, an average of 12 weeks
|
|
National Institutes of Health Stroke Scale (NIHSS) score
Time Frame: through study completion, an average of 12 weeks
|
The National Institutes of Health Stroke Scale (NIHSS) is used to assess stroke severity, with scores ranging from 0 to 42.
A higher score indicates a worse neurological impairment, where 0 represents no stroke symptoms, and higher scores reflect increasing severity of stroke-related deficits.
|
through study completion, an average of 12 weeks
|
|
Modified Rankin Scale (mRS)
Time Frame: through study completion, an average of 12 weeks
|
The Modified Rankin Scale (mRS) is used to assess functional outcomes, with scores ranging from 0 to 6.
A higher score indicates a worse outcome, where 0 represents no symptoms, and 6 indicates death.
|
through study completion, an average of 12 weeks
|
|
Duration of ICU and hospital stays
Time Frame: Through study completion, an average of 12 weeks
|
The duration of ICU stay (in days) and total hospital stay (in days) will be assessed through study completion, with an average follow-up period of 12 weeks.
|
Through study completion, an average of 12 weeks
|
|
ability to ambulate upon discharge
Time Frame: through study completion, an average of 12 weeks
|
through study completion, an average of 12 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202410128RINB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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