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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
7
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 feasability of the prosthesis and description of any adverse events.
Time frame: baseline
ad hoc check-list Adverse Event
questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events.
Time frame: day 2
ad hoc check-list Adverse Event
questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events.
Time frame: day 3
ad hoc check-list Adverse Event
questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events.
Time frame: day 4
ad hoc check-list Adverse Event
questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events.
Time frame: day 5
CR-10 Borg Scale
0-10 numerical rating scale that evaluate of the subjective perception of effort during walking
Time frame: day 5
System usability scale
a questionnaire made up of 10 questions whose answers are yes structured on a Likert scale with values 0-100 that assess the usability of the prosthesis
Time frame: baseline
System usability scale
a questionnaire made up of 10 questions whose answers are yes structured on a Likert scale with values 0-100 that assess the usability of the prosthesis
Time frame: day 5
10mwt - 10 meters walking test
to assess the walking speed
Time frame: day 2
10mwt - 10 meters walking test
to assess the walking speed
Time frame: day 3
SCT - stair climb test
to assess the capability of climb 8 stairs
Time frame: day 2
SCT - stair climb test
to assess the capability of climb 8 stairs
Time frame: day 3
TUG - Timed Up and GO
to assess lower limb capability
Time frame: day 2
TUG - Timed Up and GO
to assess lower limb capability
Time frame: day 3
6mwt - 6 minute walking test on the treadmill
to assess the fatigue
Time frame: day 4
6mwt - 6 minute walking test on the treadmill
to assess the fatigue
Time frame: day 5
Gait analisys
to assess the gait pattern
Time frame: day 5
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.