Clinical Research Directory

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 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.

Effect of a Prehabilitation Mobile Application Versus Standard of Care Before Colon Cancer Surgery.

Pilot study to evaluate the effect of prehabilitation programme through a mobile application PREHapp in colon cancer surgery. The objectives of this pilot study were to evaluate the usability of the PREHapp for people undergoing colon cancer surgery, estimate the effect of the app on functional recovery after surgery and to evaluate complications during the postoperative period after 4 weeks of follow-up.

NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE)

The study's objective is to conduct a Phase II randomized controlled trial examining the preliminary efficacy of the VoiceLove app compared to usual care on maternal postpartum depression in mothers with infants admitted to the Neonatal Intensive Care Unit (NICU). Primary aim: Assess the effects of VoiceLove on maternal postpartum depression, measured by the Edinburgh Postnatal Depression Scale (EPDS). The estimates from this study will be used for a future definitive Phase III trial. Secondary aim: Assess feasibility, acceptability, and patterns of communication and engagement among mothers, partners, and NICU clinicians during the NICU hospitalization, measured through app usage metrics, satisfaction surveys, and qualitative interviews. Additionally, we will evaluate effects of infant length of stay.

Sample Collection and Instruction Optimization

The aim of this study is to improve the instructions for use and to evaluate the usability of a novel first-void urine collection device.

Conventional Vestibular Training Versus Immersive Virtual Reality- Based Vestibular in Multiple Sclerosis

The effectiveness of convectional vestibular training for balance and dizziness rehabilitation in people with multiple sclerosis has been recently demonstrated in a meta-analysis by this research team (doi: 10.3390/jcm9020590). Furthermore, non-immersive virtual reality-based environments seem to be useful for balance and gait rehabilitation in this population (doi: 10.1177/0269215518768084). However, nothing is known about the feasibility and effectiveness of immersive virtual reality-based rehabilitation in people with multiple sclerosis. The primary aim of this research is to determine the feasibility, safety and effectiveness of an immersive virtual reality-based vestibular training for dizziness, balance and fatigue rehabilitation, compared to conventional vestibular training.

Improving Providers' Decision-Making and Reducing Information Overload Using Information Visualization in EHRs

This study aims to test the efficacy of an information visualization dashboard on decision-making using a randomized controlled trial with crossover. This study aims to test the efficacy of using an information visualization dashboard on ICU providers' decision-making, efficiency, and performance compared to their institutional EHR through a randomized control trial with crossover.

AI-based Informational Assistant for Automated Point-of-care Documentation and Protocol Retrieval

Clinical rounds in the intensive care unit (ICU) involve substantial manual documentation. Retrieving the correct protocol text and structuring notes at the bedside is time-consuming and may contribute to variation in documentation quality. Modern artificial intelligence (AI) can help structure existing information and automate protocol look-ups within a restricted, manually selected document set. The tool evaluated in this study acts as an AI-based informational assistant for clinicians. It (1) pre-populates a standardized physical-exam and daily-rounds format, (2) prepares a concise ICU course/overview using predefined formatting, and (3) retrieves relevant passages from protocols to enable rapid consistency checks by the clinician. The AI-based informational assistant does not provide treatment recommendations or patient-specific advice; all outputs require clinician verification and clinical responsibility remains with the physician.

The Fit With Us Study

The purpose of this 32-week study is to use an innovative experimental design known as SMART (Sequential Multiple Assignment Randomized Trial), which will allow us to determine the best way to sequence the delivery of teleexercise (referred to as an adaptive intervention), combined with predictive analytics on participant adherence in a stepped program of physical activity interventions. All 257 participants will have access to a library of recorded video exercise content, and a weekly wellness article. Some participants will receive health coaching calls (1st randomization). Analytic data will be used to determine which participants are responding or not responding to the intervention. Participants not responding after 4 weeks will receive either live one-on-one or group exercise training (2nd randomization). After 8 weeks, the participant will receive only pre-recorded exercise content and articles for a 24-week maintenance phase (weeks 9-32). The study outcomes are: The effectiveness of the adaptive interventions; Exploring mediating and moderating variables; Sensitivity analysis of the predictive analytics.

Usability Study of Gestational and Postpartum Weight Management Program

The principal aim of this study is to evaluate the usability of the Hope-D gestational and 6 months postpartum weight management program. We will evaluate the usability, functionality, and acceptability of the developed Hope-D weight management program that includes digital pathway for weight management, general or individual weight management plan and individual or group coaching for weight management from pregnancy to 6 months postpartum.

Feasibility and Acceptability of the Technology Based Enhanced Gender Support Platform Implementation With Parents

This is a small pilot feasibility and acceptability study of implementing a Technology-Enhanced Gender Support (TEGS) platform with parents and caregivers. Parents and caregivers who consent to participate will complete an electronic survey at baseline. They will then receive access to the TEGS platform and complete follow up surveys 1 mo and 3 mo after. Each participant will also be given the option to participate in an exit interview.

AKTIIA OBPM to Assess CPAP Effect on Blood Pressure in Obstructive Sleep Apnea

The goal of this clinical trial is to learn if positive airway pressure (CPAP) therapy works for blood pressure (BP) control in obstructive sleep apnea (OSA) adult patients plus undiagnosed hypertension (HBP), using a cuffless bracelet for continual optical BP monitoring (AKTIIA OBPM). It will also learn if CPAP improves cardiac function in these patients using speckle tracking echocardiography (STE) and to learn about ease of use and patient experience with AKTIIA device and AKTIIA OBPM. The main questions it aims to answer are: * Does CPAP reduce systolic BP (and other BP metrics) in this population? * Does CPAP improve cardiac function in the same population? Researchers will compare BP metrics derived from AKTIIA OBPM and STE metrics in a before and after CPAP therapy to evaluate its therapeutic effect. Participants will: * Take a CPAP titration and telemonitoring program for 12 weeks (from the titration date) * Take an AKTIIA OBPM one week before CPAP and 12 weeks since CPAP titration date * Take a STE test twice, before starting CPAP and 12 weeks after CPAP titration date * Take an online survey about easy of use and patient experience with AKTIIA OBPM device