The CYBERnetic Lower Limb Cocognitive Ortho-prosthesis Plus Plus, 1st Clinical Study (CLs++) (NCT03376919) | Clinical Trial Compass
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The CYBERnetic Lower Limb Cocognitive Ortho-prosthesis Plus Plus, 1st Clinical Study (CLs++)
16 participantsStarted 2018-01-01
Plain-language summary
The aim of the study is to assess the efficacy and the usability of the cyberlegs ++ ortho prosthesis to improve the mobility and the quality of life in transfemoral amputees . This research focusses on the physical and mental effort needed in locomotion-related tasks and human robot interaction in transfemoral amputees using a novel active prosthesis. This is an international project and foresees 2 clinical studies aimed at assessing the efficacy of the CLs++ modules in different settings.
In this first clinical study, 16 patients with unilateral trans-femoral amputation, 8 at the Vrije Universiteit Brussel Department Human Physiology Research group (VUB-MFYS) and 8 at the Don Gnocchi Foundation, center of Florence.
Who can participate
Age range
30 Years – 80 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:
Unilateral trans-femoral amputees both sex age: 30 - 80 yrs Functional K-level 1-4
Exclusion Criteria:
* Severe comorbidity (hemiplegia, degenerative nervous system diseases, severe hip or knee arthrosis,chronic heart failure, chronic obstructive pulmonary, hip or knee replacement, severe sensory deficit
* Pain of the stump/socket poor fitting
* Inability to walk (safely) on a treadmill
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.