Quality Improvement Initiative for Enhancing Early Mobilization in Intracerebral Hemorrhage Patients

NCT06811350 | Active Not Recruiting

• 1 other identifier: 202410128RINB
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Intracerebral Hemorrhage; Early Mobilization

Keywords

Intracerebral hemorrhage; Early mobilization; Stroke unit; Clinical pathway

Outcome Measures

Primary Outcomes (1)

• Modified ICU mobility scale

  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 Outcomes (5)

• the time to first mobilization

  Through study completion, an average of 12 weeks

• National Institutes of Health Stroke Scale (NIHSS) score

  through study completion, an average of 12 weeks

• Modified Rankin Scale (mRS)

  through study completion, an average of 12 weeks

• Duration of ICU and hospital stays

  Through study completion, an average of 12 weeks

• ability to ambulate upon discharge

  through study completion, an average of 12 weeks

Study Arms (1)

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.

Procedure: post-implementation cohort

Interventions

post-implementation cohort PROCEDURE

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.

pre-implementation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Tiapei, 100, Taiwan

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: February 6, 2025
• Study Start: November 28, 2024
• Primary Completion: February 14, 2025
• Study Completion: November 12, 2025
• Last Updated: November 18, 2025

Record last verified: 2024-11

Locations

TW (1)