The aim of the present study is to verify the functionalitỳ, the degree of safety and the reliability of devices composed of an intelligent socket that allows the detection of biosignals and provides vibrotactile feedback and a prosthesis with active knee and ankle joints and a sensorised foot, for people with trans-femoral or trans-tibial amputation, which allows the optimisation of the gait cycle by providing active assistance at the knee and ankle joints according to the specific movement made by the user. The prototype devices are innovative in that they make it possible to optimise the benefits generated by the presence of actuated joints by exploiting the biosignals detected to ensure optimal functionalitỳ in the performance of activities̀ of daily living.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
8
These 3 sessions will commence only upon successful completion of the prosthesis safety and reliability tests conducted in the preceding sessions. For each module combination, a session will be conducted to assess motor performance through the acquisition of spatiotemporal parameters and energy efficiency parameters of gait. Motor performance will be evaluated using functional assessment tests and data will be recorded during the following activities: * parallel bar walking on flat ground * parallel bar walking on an inclined surface * treadmill walking with a safety harness * stair climbing/descending with a handrail * standing up and sitting down from a chair within parallel bars At the end of each session, satisfaction questionnaires (ad hoc questionnaire) will be completed. At the end of the experiment, a usability scale for the devices (ad hoc System Usability Scale) will be completed. Each session is expected to last approximately 2.5 hours.
IRCCS Fondazione Don Carlo Gnocchi
Florence, FI, Italy
Ad hoc check list for Adverse Event
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Time frame: baseline
Ad hoc check list for Adverse Event
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Time frame: day 1
Ad hoc check list for 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 for 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 for 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 for Adverse Event
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Time frame: day 5
Ad hoc check list for Adverse Event
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
Time frame: day 6
Borg Scale
0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking.
Time frame: day 1
Borg Scale
0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking.
Time frame: day 2
Borg Scale
0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking.
Time frame: day 3
Borg Scale
0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking.
Time frame: day 4
Borg Scale
0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking.
Time frame: day 5
10mwt - 10 meters walking test
to evaluate walking capacity measured in seconds
Time frame: baseline
10mwt - 10 meters walking test
to evaluate walking capacity measured in seconds
Time frame: day 4
6mwt - 6 minutes walking test
to evaluate walking capacity measured in metres
Time frame: baseline
System Usability Scale
a questionnaire made up of 10 questions whose answers are yes structured on a Likert scale with 0-100 that assesses the usability of the prosthesis.
Time frame: day 6.
TUG - Time Up and Go
to assess lower limb capabilities in seconds
Time frame: baseline
TUG - Time Up and Go
to assess lower limb capabilities in seconds
Time frame: day 4
SCT - Stair Climbing Test
to assess the capabilities of climb 8 stairs in seconds
Time frame: baseline
SCT - Stair Climbing Test
to assess the capabilities of climb 8 stairs in seconds
Time frame: day 4
6mwt - 6 minutes walking test
to evaluate walking capacity measured in metres
Time frame: day 6
FCT - Functional Reach Test
to assess the balance in centimeters
Time frame: baseline
Functional Reach Test
to assess the balance in centimeters
Time frame: day 5
Cost of Transport -COT
To assess metabolic consumption
Time frame: day 6
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