Primary Intracerebral HemorrhageNCT06811350
Quality Improvement Initiative for Enhancing Early Mobilization in Intracerebral Hemorrhage Patients
An observational study of Primary Intracerebral Hemorrhage and Early Mobilization, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Intracerebral Hemorrhage, Early Mobilization
- What is being tested?
- post-implementation cohort
- Type of treatment
- Surgery or procedure
- How many people
- 198 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Nov 2024to 12 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Clinical diagnosis of primary ICH
- ICH score from 0 to 4
- Patients In line with the stroke center's standard criteria for early rehabilitation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- post-implementation cohort
- Keywords
- Intracerebral hemorrhage, Early mobilization, Stroke unit, Clinical pathway
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post-implementation cohortProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: post-implementation cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 12 weeks
Secondary outcomes (5)
the time to first mobilization
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.
Measured: Through study completion, an average of 12 weeks
National Institutes of Health Stroke Scale (NIHSS) score
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.
Measured: through study completion, an average of 12 weeks
Modified Rankin Scale (mRS)
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.
Measured: through study completion, an average of 12 weeks
Duration of ICU and hospital stays
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.
Measured: Through study completion, an average of 12 weeks
ability to ambulate upon discharge
Measured: through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start28 Nov 2024
- Primary completion14 Feb 2025
- Study completion12 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811350
- Sponsor's protocol ID
- 202410128RINB
- Status last verified
- Nov 2024
- First submitted
- 13 Jan 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Improvement Initiative for Enhancing Early Mobilization in Intracerebral Hemorrhage Patients: Pre-Post Implementation of a Structured Clinical Pathway
- ClinicalTrials.gov ID
- NCT06811350
- Acronym / sponsor ID
- 202410128RINB
- Keywords
- Intracerebral hemorrhage, Early mobilization, Stroke unit, Clinical pathway
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 12 Nov 2025 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pre-implementation cohort | – | Procedure: post-implementation cohortPatients received conventional care without a structured mobility pathway, with mobilization decisions made at the discretion of the attending physician and rehabilitation team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Clinical diagnosis of primary ICH
- ICH score from 0 to 4
- Patients In line with the stroke center's standard criteria for early rehabilitation
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| post-implementation cohortPatients 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. | Procedure or surgery | pre-implementation cohort |
Primary outcome
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.
5 secondary outcomes
the time to first mobilization
Time frame: 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
Modified Rankin Scale (mRS)
Time frame: through study completion, an average of 12 weeks
Duration of ICU and hospital stays
Time frame: Through study completion, an average of 12 weeks
ability to ambulate upon discharge
Time frame: through study completion, an average of 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Intracerebral Hemorrhage and Early Mobilization, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified ICU mobility scale (time frame: through study completion, an average of 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.