Advanced Robotic Beds for the Early Rehabilitation of Cardiac Surgery Patients

NCT ID: NCT07273669

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-22
• Study Completion Date: 2027-01-31

Brief Summary

The goal of this clinical trial is to evaluate whether LOLE.K, a new and specialized robotic bed, is effective in the rehabilitation of patients who have undergone surgery. The primary objectives of the trial are:

• Efficacy of LOLE.K: Does the LOLE.K robotic bed improve early rehabilitation in patients who undergone cardiac surgery?
• Impact on recovery: Does LOLE.K influence wound healing, muscle and neurological recovery, and psychological well-being?

To address these questions, the researchers will compare the use of LOLE.K with standard physical therapy to determine whether the robotic bed results in better outcomes in post-operative rehabilitation.

Detailed Description

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:

1. Is LOLE.K effictive in enhancing early rehabilitation among patients who have undergone cardiac surgery?

2. 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.

1. Project Objectives Primary Objective: To assess the effectiveness of multirole robotic beds (LOLE.K) for early rehabilitation in cardiac surgery patients.

2. 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.

3. Experimental Design:

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

4. 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.

5. Data Colection Data Types: Demographic, clinical, physical, echocardiographic, and wound-healing data.

Devices: LOLE.K robotic beds and echography machines.

6. 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.

7. 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.

8. 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.

Conditions

AORTIC VALVE DISEASES; Mitral Valve Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Use of the robotic bed

LOLE.K use

Group Type: EXPERIMENTAL

use of the robotic bed

Intervention Type: DEVICE

use of the robotic bed LOLE.K for the early rehabilitation

Physicians standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

use of the robotic bed

use of the robotic bed LOLE.K for the early rehabilitation

Intervention Type: DEVICE

Eligibility Criteria

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%

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Salerno

OTHER

Sponsor Role: lead

Responsible Party

Gennaro Galasso

Professor of cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AOU San Giovanni di Dio e Ruggi d'Aragona

Salerno, Campani, Italy

Countries

Italy

References

Noss C, Prusinkiewicz C, Nelson G, Patel PA, Augoustides JG, Gregory AJ. Enhanced Recovery for Cardiac Surgery. J Cardiothorac Vasc Anesth. 2018 Dec;32(6):2760-2770. doi: 10.1053/j.jvca.2018.01.045. Epub 2018 Jan 31.

Reference Type: BACKGROUND

PMID: 29503121 (View on PubMed)

Lay-Ekuakille A, Chiffi C, Celesti A, Rahman MZU, Singh SP. Infrared Monitoring of Oxygenation Process Generated by Robotic Verticalization in Bedridden People. IEEE Sens J. 2021 Mar 25;21(13):14426-14433. doi: 10.1109/JSEN.2021.3068670. eCollection 2021 Jul 1.

Reference Type: BACKGROUND

PMID: 35790096 (View on PubMed)

Other Identifiers

PNRR-MCNT2-2023-12378283

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PNRR-MCNT2-2023-12378283

Identifier Type: -

Identifier Source: org_study_id