User ExperienceNCT07496346
Integration of a Robotic Platform for Clinical Monitoring of Patients With Severe Acquired Brain Injury in High-Intensity Care Units
A study testing Robotic platform monitoring system in people with User Experience and Usability, run by Ernesto Losavio.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- User Experience, Usability, Acceptability
- What is being tested?
- Robotic platform monitoring system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official 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
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 more systematic data collection and timely clinical assessment.
Read more
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 may be possible to support patient monitoring and clinical workflow, particularly 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 CO-ROBOTICS S.R.L. through the PON SI-ROBOTICS project. The system is designed to support the monitoring of patients' clinical conditions by integrating physiological and clinical data and identifying predefined signs of potential deterioration. It supports healthcare professionals by providing clinical information and automated alerts that prompt healthcare-professional review.
The study is a low-intensity, non-randomized controlled pilot feasibility interventional study conducted in a Neurorehabilitation Unit. Patients with varying levels of clinical severity, classified according to the Glasgow Coma Scale, are enrolled and allocated to one of 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 evaluated using predefined feasibility and technical measures together with validated assessment tools, including the System Usability Scale (SUS) and the Health and Safety Executive Stress Indicator Tool (HSE). The specific role and interpretation of these measures are defined in the study protocol.
The integrated MOVER-L/ROB.IN.CARE system combines robotic assistance with the acquisition and integration of physiological and clinical data through a dedicated software architecture. The platform incorporates 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 risk assessment in patients with suspected infection, and the Kidney Disease: Improving Global Outcomes (KDIGO) criteria for the assessment of acute kidney injury.
The present pilot study is intended to characterize the feasibility of integrating the MOVER-L/ROB.IN.CARE system into routine neurorehabilitation practice, including its technical performance, usability, safety, acceptability, and integration into the clinical workflow. The findings are intended to identify implementation requirements and sources of variability and to inform the design of subsequent adequately powered studies evaluating the clinical impact of robotic monitoring.
- Conditions
- User Experience, Usability, Acceptability, Satisfaction
- Being tested
- Robotic platform monitoring system
- Keywords
- Robotic platform, Monitoring system
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic platform monitoring systemDevice
Also called robotic platform, monitoring system
The MOVER-L robotic platform, integrated with the ROB.IN.CARE clinical decision-support software, will support patient monitoring by integrating physiological and clinical data acquired from connected medical devices, dedicated sensors, and clinical assessments. The software will use these data to calculate established clinical scores, including MEWS, qSOFA, and KDIGO, and to characterize the patient's clinical risk status. When predefined clinical thresholds are reached, the system will generate alerts prompting review by healthcare professionals. All alerts will be interpreted within the patient's clinical context, and all diagnostic and therapeutic decisions will remain under the responsibility of the healthcare team.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants allocated to the experimental group will receive standard clinical care in addition to monitoring supported by the MOVER-L robotic platform and ROB.IN.CARE software. Robot-assisted monitoring will be performed for approximately 12 hours per day for five consecutive days. Receives: Device: Robotic platform monitoring system |
| Control Group | No intervention | Participants allocated to the control group will receive standard clinical care according to routine clinical practice, including conventional medical and nursing assessments. No robotic monitoring will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health and Safety Executive (HSE) Management Standards Indicator Tool
The Health and Safety Executive (HSE) Management Standards Indicator Tool is a 35-item questionnaire assessing psychosocial working conditions across seven domains: demands, control, managerial support, peer support, relationships, role, and change. In the present pilot study, the HSE Indicator Tool will be used to characterize the work-related organizational context of participating healthcare professionals and will not be interpreted as a measure of change attributable to the 5-day robotic intervention. The questionnaire will be administered once to participating healthcare professionals.
Measured: Following exposure to the robotic system, at the end of the 5-day study period.
System Usability Scale (SUS)
The System Usability Scale (SUS) is a validated 10-item questionnaire used to assess perceived system usability. Each item is rated on a 5-point Likert scale. Scores are calculated according to the standard SUS scoring procedure and transformed to a total score ranging from 0 to 100, with higher scores indicating greater perceived usability. The questionnaire will be administered once to participating healthcare professionals following their exposure to the MOVER-L/ROB.IN.CARE system.
Measured: Following exposure to the robotic system, at the end of the 5-day study period.
Secondary outcomes (9)
Oxygen Saturation
Peripheral oxygen saturation (SpO₂) measured by pulse oximetry (%).
Measured: From enrollment to the end of the 5-day study period
Heart Rate
Heart rate measured in beats per minute (bpm).
Measured: From enrollment to the end of the 5-day study period
Systolic Blood Pressure
Systolic blood pressure measured in millimeters of mercury (mmHg).
Measured: From enrollment to the end of the 5-day study period
Body Temperature
Body temperature measured in degrees Celsius (°C).
Measured: From enrollment to the end of the 5-day study period
Respiratory Rate
Respiratory rate measured in breaths per minute (breaths/min).
Measured: From enrollment to the end of the 5-day study period
Level of Consciousness (Glasgow Coma Scale)
Level of consciousness assessed using the Glasgow Coma Scale (GCS), comprising Eye Opening, Verbal Response, and Motor Response components, with a total score ranging from 3 to 15 when all components are testable. Automated assessment is restricted to GCS $\geq$ 12, whereas lower or non-testable states require bedside assessment by healthcare professionals.
Measured: From enrollment to the end of the 5-day study period
Urine Output
Urine output expressed in mL/hour. Hourly measurements are obtained from the electronic urinometer and the three most recent hourly measurements are entered into ROB.IN.CARE every 3 hours.
Measured: From enrollment to the end of the 5-day study period.
Serum Creatinine
Serum creatinine concentration measured in mg/dL and used as a component of KDIGO acute kidney injury assessment.
Measured: At enrollment and when clinically available during the 5-day study period.
AVPU Level of Consciousness
Level of consciousness assessed using the Alert, Verbal, Pain, Unresponsive (AVPU) scale.
Measured: From enrollment to the end of the 5-day study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study startOct 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for User ExperienceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are allocated in a 1:1 ratio to either the experimental group or the control group. Allocation is determined by the responsible physician according to predefined clinical eligibility criteria and organizational considerations; no random sequence-generation procedure is used.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ernesto Losavio
- Sponsor type
- University, hospital or other
- Collaborators
- Item Oxygen
- Responsible party
- Sponsor-investigator, Ernesto Losavio, Istituti Clinici Scientifici Maugeri SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496346
- Sponsor's protocol ID
- 7902
- Status last verified
- Oct 2026
- First submitted
- 19 Mar 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07496346
- Acronym / sponsor ID
- 7902
- Conditions
- User Experience, Usability, Acceptability, Satisfaction
- Keywords
- Robotic platform, Monitoring system
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Ernesto LosavioUniversity, hospital or other
- Collaborators
- Item Oxygen
- Study start
- Oct 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 more systematic data collection and timely clinical assessment.
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 may be possible to support patient monitoring and clinical workflow, particularly 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 CO-ROBOTICS S.R.L. through the PON SI-ROBOTICS project. The system is designed to support the monitoring of patients' clinical conditions by integrating physiological and clinical data and identifying predefined signs of potential deterioration. It supports healthcare professionals by providing clinical information and automated alerts that prompt healthcare-professional review.
The study is a low-intensity, non-randomized controlled pilot feasibility interventional study conducted in a Neurorehabilitation Unit. Patients with varying levels of clinical severity, classified according to the Glasgow Coma Scale, are enrolled and allocated to one of 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 evaluated using predefined feasibility and technical measures together with validated assessment tools, including the System Usability Scale (SUS) and the Health and Safety Executive Stress Indicator Tool (HSE). The specific role and interpretation of these measures are defined in the study protocol.
The integrated MOVER-L/ROB.IN.CARE system combines robotic assistance with the acquisition and integration of physiological and clinical data through a dedicated software architecture. The platform incorporates 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 risk assessment in patients with suspected infection, and the Kidney Disease: Improving Global Outcomes (KDIGO) criteria for the assessment of acute kidney injury.
The present pilot study is intended to characterize the feasibility of integrating the MOVER-L/ROB.IN.CARE system into routine neurorehabilitation practice, including its technical performance, usability, safety, acceptability, and integration into the clinical workflow. The findings are intended to identify implementation requirements and sources of variability and to inform the design of subsequent adequately powered studies evaluating the clinical impact of robotic monitoring.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are allocated in a 1:1 ratio to either the experimental group or the control group. Allocation is determined by the responsible physician according to predefined clinical eligibility criteria and organizational considerations; no random sequence-generation procedure is used.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Robotic platform monitoring systemParticipants allocated to the experimental group will receive standard clinical care in addition to monitoring supported by the MOVER-L robotic platform and ROB.IN.CARE software. Robot-assisted monitoring will be performed for approximately 12 hours per day for five consecutive days. |
| Control Group | No intervention | –Participants allocated to the control group will receive standard clinical care according to routine clinical practice, including conventional medical and nursing assessments. No robotic monitoring will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic platform monitoring systemAlso: robotic platform, monitoring systemThe MOVER-L robotic platform, integrated with the ROB.IN.CARE clinical decision-support software, will support patient monitoring by integrating physiological and clinical data acquired from connected medical devices, dedicated sensors, and clinical assessments. The software will use these data to calculate established clinical scores, including MEWS, qSOFA, and KDIGO, and to characterize the patient's clinical risk status. When predefined clinical thresholds are reached, the system will generate alerts prompting review by healthcare professionals. All alerts will be interpreted within the patient's clinical context, and all diagnostic and therapeutic decisions will remain under the responsibility of the healthcare team. | Device | Experimental Group |
Primary outcome
Health and Safety Executive (HSE) Management Standards Indicator Tool
Time frame: Following exposure to the robotic system, at the end of the 5-day study period.
The Health and Safety Executive (HSE) Management Standards Indicator Tool is a 35-item questionnaire assessing psychosocial working conditions across seven domains: demands, control, managerial support, peer support, relationships, role, and change. In the present pilot study, the HSE Indicator Tool will be used to characterize the work-related organizational context of participating healthcare professionals and will not be interpreted as a measure of change attributable to the 5-day robotic intervention. The questionnaire will be administered once to participating healthcare professionals.
System Usability Scale (SUS)
Time frame: Following exposure to the robotic system, at the end of the 5-day study period.
The System Usability Scale (SUS) is a validated 10-item questionnaire used to assess perceived system usability. Each item is rated on a 5-point Likert scale. Scores are calculated according to the standard SUS scoring procedure and transformed to a total score ranging from 0 to 100, with higher scores indicating greater perceived usability. The questionnaire will be administered once to participating healthcare professionals following their exposure to the MOVER-L/ROB.IN.CARE system.
9 secondary outcomes
Oxygen Saturation
Time frame: From enrollment to the end of the 5-day study period
Heart Rate
Time frame: From enrollment to the end of the 5-day study period
Systolic Blood Pressure
Time frame: From enrollment to the end of the 5-day study period
Body Temperature
Time frame: From enrollment to the end of the 5-day study period
Respiratory Rate
Time frame: From enrollment to the end of the 5-day study period
Level of Consciousness (Glasgow Coma Scale)
Time frame: From enrollment to the end of the 5-day study period
Urine Output
Time frame: From enrollment to the end of the 5-day study period.
Serum Creatinine
Time frame: At enrollment and when clinically available during the 5-day study period.
AVPU Level of Consciousness
Time frame: From enrollment to the end of the 5-day study period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic platform monitoring system in people with User Experience and Usability, run by Ernesto Losavio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health and Safety Executive (HSE) Management Standards Indicator Tool (time frame: Following exposure to the robotic system, at the end of the 5-day study period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.