Integration of a Robotic Platform for Clinical Monitoring of Patients With Severe Acquired Brain Injury in High-Intensity Care Units

A Pilot Study on the Integration of the Rob-In Care Robotic Platform in High-Intensity Care Units for Monitoring Patients With Severe Acquired Brain Injury

Frailty is not related exclusively to age, but represents a state of increased biological and clinical vulnerability characterized by reduced functional reserve and greater susceptibility to adverse events, even in response to minor stress factors. In patients with complex conditions, such as severe acquired brain injuries, early detection and prompt treatment of clinical deterioration are essential to reduce the risk of acute readmission, complications, and in-hospital mortality. Many of these events are potentially predictable and preventable, given the presence of appropriate monitoring systems.

Advanced care models, including early warning systems, have been developed to support healthcare professionals in identifying patients at risk by detecting significant changes in physiological parameters. In recent years, technological innovations-particularly in the fields of robotics and telemedicine-have created new opportunities to enhance clinical monitoring, enabling continuous data collection and more timely, proactive interventions.

Social assistive robots are emerging as promising tools in healthcare settings. These systems can support clinicians and nurses in routine monitoring activities, help reduce workload, and facilitate more efficient and personalized care. By integrating robotic assistance with digital health platforms, it is possible to improve the quality and responsiveness of patient management, especially in high-complexity environments such as neurorehabilitation units.

This study focuses on the use of an innovative robotic telemedicine system based on the integration of the MOVER-L prototype with the ROB.IN.CARE platform, promoted by Item Oxygen (Bari, Italy). The system is designed to continuously monitor patients' clinical conditions, collecting vital parameters and identifying early signs of deterioration. It supports healthcare professionals by providing real-time data and alerts, enabling earlier and more targeted interventions.

The study is a low-intensity interventional clinical trial conducted in a Neurorehabilitation Unit. Patients with varying levels of clinical severity, classified according to the Glasgow Coma Scale, are enrolled and divided into two groups: a control group receiving standard care and an experimental group monitored using the robotic system in addition to usual care.

The primary objective of the study is to evaluate the feasibility, usability, safety, and reliability of this robotic telemedicine solution in a real clinical setting. In addition, the study assesses its acceptability among both patients and healthcare professionals. These aspects are measured using validated tools, including the System Usability Scale (SUS) and the Health and Safety Executive Stress Scale (HSE), to understand the impact of the technology on user experience and workload.

The integrated MOVER-L/ROB.IN.CARE system combines robotic assistance with continuous monitoring of vital signs and advanced software architecture. The platform incorporates predictive algorithms designed to stratify clinical risk and assess patient severity. It utilizes established clinical scoring systems, such as the Modified Early Warning Score (MEWS) for early detection of clinical deterioration, the quick Sequential Organ Failure Assessment (qSOFA) for sepsis risk evaluation, and the Kidney Disease: Improving Global Outcomes (KDIGO) criteria for the assessment of acute kidney injury.

By enabling early identification of clinical worsening, the system aims to improve the timeliness and effectiveness of healthcare interventions, optimize clinical workflow, and reduce the risk of adverse events and complications. Ultimately, this study explores whether robotic telemedicine can represent a safe, feasible, and valuable tool to enhance the management of fragile patients in neurorehabilitation settings.

Study Overview

• Status: Not yet recruiting
• Conditions: Satisfaction; Usability; Acceptability; User Experience
• Intervention / Treatment: Device: Robotic platform monitoring system

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Admission to the Neurorehabilitation Unit
• Requirement for clinical monitoring and/or sub-intensive care
• Ability to provide informed consent, or availability of a legally authorized representative to provide consent

Exclusion Criteria:

• No indication for intensive or sub-intensive clinical monitoring
• Expected hospitalization duration insufficient to complete the study protocol
• Participation in another clinical study that may interfere with the present study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; The experimental group will undergo monitoring with the robotic platform.	Device: Robotic platform monitoring system; The robot will observe patients and collect health data through clinical assessment scales including MEWS, qSOFA, and KDIGO, using the dedicated software application on a tablet. The data collected will then be processed to determine the patient's current risk status. If necessary, the robot will alert medical and nursing staff to the patient's condition in order to stabilize it as quickly as possible.; Other Names: robotic platform; monitoring system
No Intervention: Control Group; The control group will undergo the routine medical and nursing evaluations and measurements as per standard clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HSE Stress Scale	The Health and Safety Executive (HSE) Management Standards Indicator Tool is a validated questionnaire developed by the United Kingdom's Health and Safety Executive to assess work-related stress. It evaluates six key domains associated with workplace stress: demands, control, support, relationships, role, and change. The total score ranges from 38 to 190, with higher scores indicating lower levels of work-related stress (i.e., better working conditions).	At the end of treatment (1 week)
System Usability Scale (SUS)	The System Usability Scale (SUS) is a validated 10-item questionnaire used to assess the usability of a system. It evaluates users' perceived ease of use and satisfaction, reflecting the likelihood that the system will be accepted and used in the future. The total score ranges from 10 to 50, with higher scores indicating better perceived usability. The scale will be administered to nursing and medical staff.	At the end of treatment (1 week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen Saturation	Peripheral oxygen saturation (SpO₂) measured by pulse oximetry (%).	From enrollment to the end of treatment at 1 week
Heart Rate	Heart rate measured in beats per minute (bpm).	From enrollment to the end of treatment at 1 week
Pulse Rate	Pulse rate measured in beats per minute (bpm).	From enrollment to the end of treatment at 1 week
Diastolic Blood Pressure	Diastolic blood pressure measured in millimeters of mercury (mmHg).	From enrollment to the end of treatment at 1 week
Body Temperature	Body temperature measured in degrees Celsius (°C).	From enrollment to the end of treatment at 1 week
Respiratory Rate	Respiratory rate measured in breaths per minute (breaths/min).	From enrollment to the end of treatment at 1 week
Level of Consciousness (Glasgow Coma Scale)	Level of consciousness assessed using the Glasgow Coma Scale (GCS), with scores ranging from 3 to 15, where higher scores indicate better neurological status.	From enrollment to the end of treatment at 1 week
Hourly Urine Output	Urine output measured hourly, expressed in milliliters per hour (mL/hour).	From enrollment to the end of treatment at 1 week
Laboratory Parameters	Selected laboratory parameters will be assessed using standard clinical laboratory methods. Each parameter will be reported individually according to its specific unit of measure (e.g., mg/dL, mmol/L, g/L, or other relevant units depending on the parameter).	From enrollment to the end of treatment at 1 week

Collaborators and Investigators

• Sponsor: Ernesto Losavio
• Collaborators: Item Oxygen

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Robotic platform; Monitoring system
• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction
• Other Study ID Numbers: 7902

Drug and device information, study documents

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