Traumatic Brain InjuryCDSS-EM-ICUNCT07685145
Clinical Decision Support System for Early Mobilization in the Neuro-ICU
A study testing Clinical Decision Support System (CDSS) for Early Mobilization in people with Traumatic Brain Injury and Intracerebral Hemorrhage, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study aims to evaluate the feasibility, safety, and user acceptability of a tablet- and smartphone-based Clinical Decision Support System (CDSS) designed to guide early mobilization for patients with severe neurological conditions in the intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Traumatic Brain Injury, Intracerebral Hemorrhage, Subarachnoid Hemorrhage, Spontaneous
- What is being tested?
- Clinical Decision Support System (CDSS) for Early Mobilization
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Sep 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) admitted to the neuro-ICU or trauma ICU.
- Diagnosis of acute neurological conditions, including traumatic brain injury (TBI), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH), or acute ischemic stroke (AIS).
- Hemodynamically stable and deemed eligible for rehabilitation evaluation.
- Expected ICU stay ≥48 hours.
Who cannot join
- Pre-existing severe physical disability (modified Rankin Scale ≥4 before admission).
- Unstable intracranial pressure or craniectomy with active cerebrospinal fluid leakage.
- Unstable fractures or contraindications for mobilization as determined by the attending physician.
- Palliative care status or do-not-resuscitate (DNR) orders.
- Patients unable to participate in mobilization assessment due to medical instability or family refusal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation and Feasibility of a Clinical Decision Support System for Early Mobilization in the Intensive Care Unit
This study aims to evaluate the feasibility, safety, and user acceptability of a tablet- and smartphone-based Clinical Decision Support System (CDSS) designed to guide early mobilization for patients with severe neurological conditions in the intensive care unit (ICU). The CDSS standardizes safety screening across neurological, physiological, and device-related domains and provides graded mobility recommendations from Level 0 (passive range of motion) to Level 10 (independent ambulation).
The single-center, single-arm feasibility study will be conducted over six months in neurosurgical and trauma ICUs. Adult patients (≥18 years) with traumatic brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, or acute ischemic stroke will be included. Primary outcomes include protocol adherence, data completeness, and user satisfaction (System Usability Scale). Secondary outcomes include time to first mobilization, maximum mobility level achieved, and adverse event incidence.
- Conditions
- Traumatic Brain Injury, Intracerebral Hemorrhage, Subarachnoid Hemorrhage, Spontaneous, Acute Ischemic Stroke
- Being tested
- Clinical Decision Support System (CDSS) for Early Mobilization
- Medical subject headings
- Brain Injuries, Traumatic, Cerebral Hemorrhage, Subarachnoid Hemorrhage, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision Support System (CDSS) for Early MobilizationDevice
The CDSS is a tablet- and smartphone-based system designed to standardize safety screening and guide early mobilization decisions for neuro-ICU patients. It provides graded mobility level recommendations based on neurological, physiological, and device-related parameters.
| Study group | Role | What they receive |
|---|---|---|
| CDSS-Guided Early Mobilization | Experimental | The CDSS is a tablet- and smartphone-based system designed to standardize safety screening and guide early mobilization decisions for neuro-ICU patients. It provides graded mobility level recommendations based on neurological, physiological, and device-related parameters Receives: Device: Clinical Decision Support System (CDSS) for Early Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protocol Adherence Rate
The proportion of ICU patient-days in which the mobilization activity executed by the therapist matches the mobility level recommended by the Clinical Decision Support System (CDSS). An adherence rate of ≥80% will be considered acceptable implementation fidelity.
Measured: From ICU admission to ICU discharge (approximately up to 30 days).
Data Completeness Rate
The proportion of required data fields accurately completed within the CDSS interface. A data completeness rate of ≥90% will indicate adequate system usability and workflow compliance.
Measured: Throughout the 6-month study implementation period.
User Acceptability (System Usability Scale Score)
The mean System Usability Scale (SUS) score obtained from ICU clinicians after using the CDSS for at least 4 weeks. A mean score ≥70 will be considered satisfactory usability. The System Usability Scale (SUS) is a validated 10-item questionnaire with scores ranging from 0 to 100. Higher scores indicate better usability and greater user acceptability. A score of 70 or above is generally considered acceptable usability.
Measured: Assessed at the end of the 6-month study period.
Secondary outcomes (4)
Time to First Mobilization at Level ≥2
The number of days from ICU admission to the first mobilization episode reaching Level 2 or higher (e.g., edge-of-bed sitting or above) as determined by the CDSS mobility scale.
Measured: From ICU admission until the first mobilization (up to 30 days).
Highest Mobility Level Achieved by Day 5
The maximum mobility level achieved by each participant within the first three ICU days, based on the modified 0-10 ICU Mobility Scale recorded through the CDSS. Modified ICU Mobility Scale (0-10) ranges from 0 to 10, with higher scores indicating greater mobility and functional independence.
Measured: First 5 days after ICU admission.
Highest Mobility Level at ICU Discharge
The highest mobility level reached before ICU discharge, as recorded by the CDSS daily log.
Measured: From ICU admission to ICU discharge (approximately up to 30 days).
Incidence of Mobilization-Related Adverse Events
The frequency and type of adverse events occurring during CDSS-guided mobilization, including hemodynamic instability (MAP <65 mmHg or SBP drop >20 mmHg), oxygen desaturation (SpO₂ <90% for >30 seconds), or device dislodgement (unplanned removal of EVD, central line, or ventilator tubing).
Measured: From the first mobilization session until ICU discharge (up to 30 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start17 Sep 2025
- Primary completion22 May 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
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
- NCT07685145
- Sponsor's protocol ID
- 202507222RINA
- Other IDs
- 115S
- Acronym
- CDSS-EM-ICU
- Status last verified
- Aug 2025
- First submitted
- 21 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Feasibility of a Clinical Decision Support System for Early Mobilization in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07685145
- Acronym / sponsor ID
- CDSS-EM-ICU / 202507222RINA
- Conditions
- Traumatic Brain Injury, Intracerebral Hemorrhage, Subarachnoid Hemorrhage, Spontaneous, Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 6 Jul 2026 (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.
This study aims to evaluate the feasibility, safety, and user acceptability of a tablet- and smartphone-based Clinical Decision Support System (CDSS) designed to guide early mobilization for patients with severe neurological conditions in the intensive care unit (ICU). The CDSS standardizes safety screening across neurological, physiological, and device-related domains and provides graded mobility recommendations from Level 0 (passive range of motion) to Level 10 (independent ambulation).
The single-center, single-arm feasibility study will be conducted over six months in neurosurgical and trauma ICUs. Adult patients (≥18 years) with traumatic brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, or acute ischemic stroke will be included. Primary outcomes include protocol adherence, data completeness, and user satisfaction (System Usability Scale). Secondary outcomes include time to first mobilization, maximum mobility level achieved, and adverse event incidence.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDSS-Guided Early Mobilization | Experimental | Device: Clinical Decision Support System (CDSS) for Early MobilizationThe CDSS is a tablet- and smartphone-based system designed to standardize safety screening and guide early mobilization decisions for neuro-ICU patients. It provides graded mobility level recommendations based on neurological, physiological, and device-related parameters |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (≥18 years) admitted to the neuro-ICU or trauma ICU.
- Diagnosis of acute neurological conditions, including traumatic brain injury (TBI), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH), or acute ischemic stroke (AIS).
- Hemodynamically stable and deemed eligible for rehabilitation evaluation.
- Expected ICU stay ≥48 hours.
Key exclusion criteria (5 listed)
- Pre-existing severe physical disability (modified Rankin Scale ≥4 before admission).
- Unstable intracranial pressure or craniectomy with active cerebrospinal fluid leakage.
- Unstable fractures or contraindications for mobilization as determined by the attending physician.
- Palliative care status or do-not-resuscitate (DNR) orders.
- Patients unable to participate in mobilization assessment due to medical instability or family refusal.
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 |
|---|---|---|
| Clinical Decision Support System (CDSS) for Early MobilizationThe CDSS is a tablet- and smartphone-based system designed to standardize safety screening and guide early mobilization decisions for neuro-ICU patients. It provides graded mobility level recommendations based on neurological, physiological, and device-related parameters. | Device | CDSS-Guided Early Mobilization |
Primary outcome
Protocol Adherence Rate
Time frame: From ICU admission to ICU discharge (approximately up to 30 days).
The proportion of ICU patient-days in which the mobilization activity executed by the therapist matches the mobility level recommended by the Clinical Decision Support System (CDSS). An adherence rate of ≥80% will be considered acceptable implementation fidelity.
Data Completeness Rate
Time frame: Throughout the 6-month study implementation period.
The proportion of required data fields accurately completed within the CDSS interface. A data completeness rate of ≥90% will indicate adequate system usability and workflow compliance.
User Acceptability (System Usability Scale Score)
Time frame: Assessed at the end of the 6-month study period.
The mean System Usability Scale (SUS) score obtained from ICU clinicians after using the CDSS for at least 4 weeks. A mean score ≥70 will be considered satisfactory usability. The System Usability Scale (SUS) is a validated 10-item questionnaire with scores ranging from 0 to 100. Higher scores indicate better usability and greater user acceptability. A score of 70 or above is generally considered acceptable usability.
4 secondary outcomes
Time to First Mobilization at Level ≥2
Time frame: From ICU admission until the first mobilization (up to 30 days).
Highest Mobility Level Achieved by Day 5
Time frame: First 5 days after ICU admission.
Highest Mobility Level at ICU Discharge
Time frame: From ICU admission to ICU discharge (approximately up to 30 days).
Incidence of Mobilization-Related Adverse Events
Time frame: From the first mobilization session until ICU discharge (up to 30 days).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Clinical Decision Support System (CDSS) for Early Mobilization in people with Traumatic Brain Injury and Intracerebral Hemorrhage, 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 6 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Protocol Adherence Rate (time frame: From ICU admission to ICU discharge (approximately up to 30 days).). The study lists 3 primary outcomes in all. 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 6 Jul 2026.