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

NCT07685145 | Completed

• 2 other identifiers: 202507222RINA115S
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Time to First Mobilization at Level ≥2

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

• Highest Mobility Level Achieved by Day 5

  First 5 days after ICU admission.

• Highest Mobility Level at ICU Discharge

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

• Incidence of Mobilization-Related Adverse Events

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

Study Arms (1)

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

Device: Clinical Decision Support System (CDSS) for Early Mobilization

Interventions

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.

CDSS-Guided Early Mobilization

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital (NTUH)

Taipei, Taiwan

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Cerebral Hemorrhage; Subarachnoid Hemorrhage; Ischemic Stroke

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: July 6, 2026
• Study Start: September 17, 2025
• Primary Completion: May 22, 2026
• Study Completion: June 15, 2026
• Last Updated: July 6, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)