Interventional Study on the Evaluation of Functionality, Safety of a Robotic Prosthesis for Trans… (NCT06161961) | Clinical Trial Compass
CompletedNot Applicable
Interventional Study on the Evaluation of Functionality, Safety of a Robotic Prosthesis for Transtibial Amputations
Italy7 participantsStarted 2020-07-21
Plain-language summary
The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-tibial amputees.
The main question it aims to answer are:
* Is to verify the technical functionality, safety and reliability of the propulsive lower limb prosthesis prototype, with active ankle, so as to provide indications regarding the technical and functional developments to be implemented in the finalization of the device.
* Provide an indication of the functional effectiveness of the device and its satisfaction by patients.
Participants will perform:
* walking tests inside parallel bars on flat and/or inclined terrain;
* walking tests on treadmill;
* stair climbing/descent tests.
Who can participate
Age range
18 Years – 75 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:
* Trans-tibial lower limb amputation;
* Medicare functional classification: Level K3-K4;
* Subjects who have worn prostheses for at least 1 year (experienced wearers);
* Use of prosthesis with energy-returning prosthetic foot.
Exclusion Criteria:
* Relevant medical comorbidities (serious neurological pathologies, cardiovascular pathologies, diabetes/hypertension not stabilized, severe sensory deficits);
* Wearers of implantable cardiac medical devices (PMK or AICD);
* Cognitive impairment (MMSE corrected for age and education \<24);
* Inability or unavailability to provide informed consent;
* Severe depressive and/or anxious symptoms.
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.