Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07496346

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

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, owned by Item Oxygen Srl, which purchased the platform from the company CO-ROBOTICS S.R.L. through the PON SI-ROBOTICS project. 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Robotic platform monitoring system

Device

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

Primary outcomes

  1. HSE Stress Scale

    Time frame: At the end of treatment (1 week)

    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).

  2. System Usability Scale (SUS)

    Time frame: At the end of treatment (1 week)

    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.

Secondary outcomes

  1. Oxygen Saturation

    Time frame: From enrollment to the end of treatment at 1 week

    Peripheral oxygen saturation (SpO₂) measured by pulse oximetry (%).

  2. Heart Rate

    Time frame: From enrollment to the end of treatment at 1 week

    Heart rate measured in beats per minute (bpm).

  3. Pulse Rate

    Time frame: From enrollment to the end of treatment at 1 week

    Pulse rate measured in beats per minute (bpm).

  4. Diastolic Blood Pressure

    Time frame: From enrollment to the end of treatment at 1 week

    Diastolic blood pressure measured in millimeters of mercury (mmHg).

  5. Body Temperature

    Time frame: From enrollment to the end of treatment at 1 week

    Body temperature measured in degrees Celsius (°C).

  6. Respiratory Rate

    Time frame: From enrollment to the end of treatment at 1 week

    Respiratory rate measured in breaths per minute (breaths/min).

  7. Level of Consciousness (Glasgow Coma Scale)

    Time frame: From enrollment to the end of treatment at 1 week

    Level of consciousness assessed using the Glasgow Coma Scale (GCS), with scores ranging from 3 to 15, where higher scores indicate better neurological status.

  8. Hourly Urine Output

    Time frame: From enrollment to the end of treatment at 1 week

    Urine output measured hourly, expressed in milliliters per hour (mL/hour).

  9. Laboratory Parameters

    Time frame: From enrollment to the end of treatment at 1 week

    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).

Sponsors and collaborators

Lead sponsor

Ernesto Losavio

Other

Collaborators

  • Item Oxygen

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Jul 8, 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.

Published trials that share one or more normalized conditions with this study.