Advanced Robotic Beds for the Early Rehabilitation of Cardiac Surgery Patients (NCT07273669) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Advanced Robotic Beds for the Early Rehabilitation of Cardiac Surgery Patients
Italy20 participantsStarted 2025-09-22
Plain-language 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.
Who can participate
Age range
60 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effectiveness of LOLE.K reducing ICU and hospital stay
Timeframe: 12 months
2
Effectiveness of LOLE.K reducing duration of Mechanical ventilation
Timeframe: 12 months
3
Effectiveness of LOLE.K enhancing functional outcomes
Timeframe: Maximum 12 months for the entire study, from enrollment to 6 months after discharge
4
Effectiveness of LOLE.K in patient satisfaction
Timeframe: Maximum 12 months for the entire study, from enrollment to 6 months after discharge