AORTIC VALVE DISEASESCARENCT07273669
Advanced Robotic Beds for the Early Rehabilitation of Cardiac Surgery Patients
A study testing use of the robotic bed in people with AORTIC VALVE DISEASES and Mitral Valve Failure, run by University of Salerno at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- AORTIC VALVE DISEASES, Mitral Valve Failure
- What is being tested?
- use of the robotic bed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 22 Sep 2025to Jan 2027
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing aortic and mitral vale surgery
- patients aged between 60 and 85
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- Conditions
- AORTIC VALVE DISEASES, Mitral Valve Failure
- Being tested
- use of the robotic bed
- Keywords
- Robotic Beds, early rehabilitation, cardiac surgery, post cardiac surgery ICU
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of the robotic bedDevice
use of the robotic bed LOLE.K for the early rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Use of the robotic bed | Experimental | LOLE.K use Receives: Device: use of the robotic bed |
| Physicians standard of care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Maximum 12 months for the entire study, from enrollment to 6 months after discharge
Secondary outcomes (3)
Muscular and neurological recovery
Verify the benefits for muscle recovery with the multifunctional bed in patients undergoing cardiac surgery. The authors intend to demonstrate that the bed's special features promote muscle healing process thanks to the programming of cyclical postural transitions specific to cardiac surgery patients. The strength recovery is measured using a dynamometer for Lower limb and Handgrip-Test, evaluating the variation from T0 to T4.
The unite of measurement for this outcome is Kilogram (Kg).
Measured: Maximum 12 months for the entire study, from enrollment to 6 months after discharge
Neurological and psychological well-being
To assess Neurological and psychological well-being the authors employ 36-Item Short Form Health Survey version 2 (SF-36 v2) 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).
Measured: Maximum 12 months for the entire study, from enrollment to 6 months after discharge
wound healing
One of the objectives of this study is to demonstrate the effectiveness of the LOLE.K bed in wound healing. Through early mobilization of the patient using the cyclical postural changes provided by the multifunctional robotic bed.
To define the degree of superficial or deep wound infection is used a clinical scoring system (from 0 to 12 points).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start22 Sep 2025
- Primary completion1 May 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AORTIC VALVE DISEASESStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salerno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gennaro Galasso, University of Salerno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273669
- Sponsor's protocol ID
- PNRR-MCNT2-2023-12378283
- Other IDs
- PNRR-MCNT2-2023-12378283
- Acronym
- CARE
- Status last verified
- Sep 2025
- First submitted
- 26 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 29503121Lay-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.
PubMed 35790096
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Robotic Beds for the Early Rehabilitation of Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT07273669
- Acronym / sponsor ID
- CARE / PNRR-MCNT2-2023-12378283
- Conditions
- AORTIC VALVE DISEASES, Mitral Valve Failure
- Keywords
- Robotic Beds, early rehabilitation, cardiac surgery, post cardiac surgery ICU
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of SalernoUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 Dec 2025 (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.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of the robotic bed | Experimental | Device: use of the robotic bedLOLE.K use |
| Physicians standard of care | No intervention | – |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing aortic and mitral vale surgery
- patients aged between 60 and 85
Key exclusion criteria (7 listed)
- 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%
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 |
|---|---|---|
| use of the robotic beduse of the robotic bed LOLE.K for the early rehabilitation | Device | Use of the robotic bed |
Primary outcome
Effectiveness of LOLE.K reducing ICU and hospital stay
Time frame: 12 months
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.
Effectiveness of LOLE.K reducing duration of Mechanical ventilation
Time frame: 12 months
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.
Effectiveness of LOLE.K enhancing functional outcomes
Time frame: Maximum 12 months for the entire study, from enrollment to 6 months after discharge
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).
Effectiveness of LOLE.K in patient satisfaction
Time frame: Maximum 12 months for the entire study, from enrollment to 6 months after discharge
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.
3 secondary outcomes
Muscular and neurological recovery
Time frame: Maximum 12 months for the entire study, from enrollment to 6 months after discharge
Neurological and psychological well-being
Time frame: Maximum 12 months for the entire study, from enrollment to 6 months after discharge
wound healing
Time frame: 12 months
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 9 Dec 2025.
- Background: PubMed 29503121Noss 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.
- Background: PubMed 35790096Lay-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.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of the robotic bed in people with AORTIC VALVE DISEASES and Mitral Valve Failure, run by University of Salerno at 1 site in Italy.
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 2 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Effectiveness of LOLE.K reducing ICU and hospital stay (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07273669, which also lists 2 linked publications.
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 9 Dec 2025.