Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT07273669
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Advanced Robotic Beds for the Early Rehabilitation of Cardiac Surgery Patients
Sponsor:
University of Salerno
Organization:
Study Overview
Official Title:
Advanced Robotic Beds for the Early Rehabilitation of Cardiac Surgery Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARE
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.
* 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PNRR-MCNT2-2023-12378283 | OTHER_GRANT | Ministero della Salute, Italian Health Ministry | View |