Advanced Robotic Beds for the Early Rehabilitation of Cardiac Surgery Patients

The goal of this clinical trial is to learn whether LOLE.K, a new and specialized robotic bed, works for rehabilitation of patients following surgery.

The main research questions are:

• Is LOLE.K effictive in enhancing early rehabilitation among patients who have undergone cardiac surgery?
• Does LOLE.K influence wound healing, muscular and neurological recovery, and psychological well-being?

Researchers will compare LOLE.K bed to the usual therapy to see if LOLE.K woks better than standard post-operation rehabilitation.

• Project Objectives Primary Objective: To assess the effectiveness of multirole robotic beds (LOLE.K) for early rehabilitation in cardiac surgery patients.
• Target Population Patients: individuals aged 60-85 years undergoing aortic and mitral valve surgery.

Study Sites: University of Salerno Hospital and IRCCS Ospedale Galeazzi-Sant'Ambrogio.

• Experimental Design:

• Control Group: Standard post-operative rehabilitation.
• Experimental Group: Rehabilitation using LOLE.K robotic beds.
• Key phases

• Pilot Phase (Months 1-6): Define dataset structure, initiate patient enrollement and refine the operational algorithm.

• Enrollment Phase (Months 6-12): Collect demographic, clinical, and physical health data from enrolled patients.

• Follow-Up & Analysis Phase (Months 12-24): Perform in-depth statistical analysis and finalize outcome evalitaion.
• Data Colection Data Types: Demographic, clinical, physical, echocardiographic, and wound-healing data.

Devices: LOLE.K robotic beds and echography machines.

• Outcomes & Measurements

• Primary Outocomes: Lenght of hospital stay, ICU requirements, and rehabilitation time.
• Secondary: Lung function, mental health scores, wound-healing scores, quality of life and cardiac output improvements.

Standardized protocols for sedation and analgesia management will be applied, including the Richmond Agitation-Sedation Scale (RASS) for sedation and the Behavioral Pain Scale (BPS) or Critical Pain Observation Tool (CPOT) for pain. Also, delirium will be assessed using the Confusion Assessment Method for ICU (CAM-ICU). These parametres are critical: if patients are overly sedated or inadequately anesthetized, the results on mobilization could be confounded by these factors. Assessment of delirium is important because early mobilization could also have beneficial effects on cognitive status.

• Statistical Analysis Plan

• Descriptive Statistics: To provide an overview of baseline data.
• Regression Models: To analyze the impact of key variables on clinical outcomes.
• Machine Learning Models: To evaluate treatment efficiency based on patient data.
• Expected Outcomes The use of LOLE.K is expected to result in faster recovery times, reduced ICU stays, improved physical and mental health, and enhanced wound healing compared with standard post-operative rehabilitation.

Inclusion criteria

• patients undergoing aortic and mitral vale surgery
• patients aged between 60 and 85

Exclusion criteria

• Age < 18 years old
• inability to provide informed consent, either verbally or in writing, or unwillingness to participate in systematic follow-up
• Life expectancy < 1 year
• Recent myocardial infarction (MI) with ST segment elevation (< 72 hours)
• Left ventricular ejection fraction < 30%
• Clearance della creatinina < 30 ml/min. Further exclusion criteria included bed rest orders, patients in a palliative care setting or with therapy limitations.

Restrictions due to the device were height outside the ranfe of 190cm, weight outside the range of 115kg, pacemakers, other electrical stimulators, or implanted medical pumps.