The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-femoral 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
4
evaluation of functionality, degree of safety and reliability of the lower limb prosthesis prototype
IRCCS Fondazione Don Carlo Gnocchi
Florence, FI, Italy
ad hoc check-list Adverse Event
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Time frame: baseline
ad hoc check-list Adverse Event
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Time frame: day 2
ad hoc check-list Adverse Event
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Time frame: day 3
ad hoc check-list Adverse Event
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Time frame: day 4
ad hoc check-list Adverse Event
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Time frame: day 5
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