Quality Improvement Initiative for Enhancing Early Mobilization in Intracerebral Hemorrhage Patients

November 16, 2025 updated by: National Taiwan University Hospital

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

Active, not recruiting

Study Type

Observational

Enrollment (Estimated)

198

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tiapei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2024

Primary Completion (Actual)

February 14, 2025

Study Completion (Estimated)

November 12, 2025

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

February 2, 2025

First Posted (Actual)

February 6, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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