Clinical Decision Support System for Early Mobilization in the Neuro-ICU (CDSS-EM-ICU)

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury; Acute Ischemic Stroke; Intracerebral Hemorrhage; Subarachnoid Hemorrhage, Spontaneous
• Intervention / Treatment: Device: Clinical Decision Support System (CDSS) for Early Mobilization

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital (NTUH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CDSS-Guided Early Mobilization; 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	Device: Clinical Decision Support System (CDSS) for Early Mobilization; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Assessed at the end of the 6-month study period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	From the first mobilization session until ICU discharge (up to 30 days).

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2025
• Primary Completion (Actual): May 22, 2026
• Study Completion (Actual): June 15, 2026

Study Registration Dates

• First Submitted: June 21, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Stroke; Brain Injuries; Pathological Conditions, Signs and Symptoms; Ischemic Stroke; Brain Injuries, Traumatic; Cerebral Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: 202507222RINA; 115S (Other Grant/Funding Number: National Taiwan University Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No