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NCT Number: NCT07685145

Clinical Decision Support System for Early Mobilization in the Neuro-ICU

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.

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Key information

Conditions

Traumatic Brain Injury Acute Ischemic Stroke Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Craniocerebral Trauma Hemorrhage Intracerebral Hemorrhage Intracranial Hemorrhages Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Subarachnoid Hemorrhage Subarachnoid Hemorrhage, Spontaneous Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital (NTUH)

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Clinical Decision Support System (CDSS) for Early Mobilization

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Time to First Mobilization at Level ≥2

    Time frame: From ICU admission until the first mobilization (up to 30 days).

    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.

  2. Highest Mobility Level Achieved by Day 5

    Time frame: First 5 days after ICU admission.

    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.

  3. Highest Mobility Level at ICU Discharge

    Time frame: From ICU admission to ICU discharge (approximately up to 30 days).

    The highest mobility level reached before ICU discharge, as recorded by the CDSS daily log.

  4. Incidence of Mobilization-Related Adverse Events

    Time frame: From the first mobilization session until ICU discharge (up to 30 days).

    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).

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Implementation and Feasibility of a Clinical Decision Support System for Early Mobilization in the Intensive Care Unit

Acronym: CDSS-EM-ICU

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

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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