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NCT Number: NCT06811350

Quality Improvement Initiative for Enhancing Early Mobilization in Intracerebral Hemorrhage Patients

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. ability to ambulate upon discharge

    Time frame: through study completion, an average of 12 weeks

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Quality Improvement Initiative for Enhancing Early Mobilization in Intracerebral Hemorrhage Patients: Pre-Post Implementation of a Structured Clinical Pathway

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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