Quality Improvement Initiative for Enhancing Early Mobilization in Intracerebral Hemorrhage Patients

Active, not recruiting

• Conditions: Primary Intracerebral Hemorrhage; Early Mobilization

• Registration Number: NCT06811350
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-12-10
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-02-02
• Last Update Submitted: 2025-02-02
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06
• Primary Completion: 2025-11-12
• Study Completion: 2025-11-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 198

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified ICU mobility scale	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.

Secondary Outcome Measures

Name	Time	Method
the time to first mobilization	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.
National Institutes of Health Stroke Scale (NIHSS) score	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.
Modified Rankin Scale (mRS)	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.
Duration of ICU and hospital stays	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.
ability to ambulate upon discharge	through study completion, an average of 12 weeks

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Tiapei, Taiwan