Advanced Robotic Beds for the Early Rehabilitation of Cardiac Surgery Patients

NCT07273669 | Active Not Recruiting

• 1 other identifier: PNRR-MCNT2-2023-12378283
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Valve Failure; AORTIC VALVE DISEASES

Keywords

Robotic Beds; early rehabilitation; cardiac surgery; post cardiac surgery ICU

Outcome Measures

Primary Outcomes (4)

• Effectiveness of LOLE.K reducing ICU and hospital stay

  The autors proposal aims to reducing the ICU and Hospital stay in cardiac surgery patients through mobilization and postural drainage. The authors aim to discharge patients from the ICU within two days of surgery and discharge them from the hospital within two weeks. Therefore, the unit of measurement is expressed in the number of days elapsed from admission to discharge, both from the intensive care unit and from the hospital overall.

  12 months

• Effectiveness of LOLE.K reducing duration of Mechanical ventilation

  One of the primary objectives of this study is to achieve a reduction in the duration of mechanical ventilation compatibly with each patient's specific preoperative and postoperative conditions. In addition to the invasive ventilation phase (ventilator), a reduction in the use of non-invasive ventilation (NIV) is also sought during the immediate postoperative period, up to seven days after surgery. The unite of measurement is the number of days the patient requires non-invasive ventilation following extubation.

  12 months

• Effectiveness of LOLE.K enhancing functional outcomes

  To assess physical functioning and the associated return to usual activities, the 36-Item Short Form Health Survey version 2 (SF-36 v2) , will be administered 12 weeks after surgery. This questionnaire measures a wide range of symptoms, experiences, and health outcomes across eight domains comprising thirty-six items, addressing gaps in the assessment of patient-reported outcomes throughout the care continuum. The unit of measurement is the SF-36 domain score (0-100).

  Maximum 12 months for the entire study, from enrollment to 6 months after discharge

• Effectiveness of LOLE.K in patient satisfaction

  To characterize patient satisfaction, we will record pain, anxiety, and satisfaction levels during mobilization, all assessed using the Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 represents the worst pain imaginable. Therefore, the unit of measurement is expressed in points on a 0-10 scale.

  Maximum 12 months for the entire study, from enrollment to 6 months after discharge

Secondary Outcomes (3)

• Muscular and neurological recovery

  Maximum 12 months for the entire study, from enrollment to 6 months after discharge

• Neurological and psychological well-being

  Maximum 12 months for the entire study, from enrollment to 6 months after discharge

• wound healing

  12 months

Study Arms (2)

Use of the robotic bed

EXPERIMENTAL

LOLE.K use

Device: use of the robotic bed

Physicians standard of care

NO INTERVENTION

Interventions

use of the robotic bed DEVICE

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

Use of the robotic bed

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salerno: lead

Study Sites (1)

AOU San Giovanni di Dio e Ruggi d'Aragona

Salerno, Campani, 84131, Italy

Location

Related Publications (2)

• 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.

  PMID: 29503121 BACKGROUND

• 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.

  PMID: 35790096 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of cardiology

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: September 22, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

IT (1)