An interventional study of prototype prosthetic group in Amputation, Traumatic Amputations and Leg Amputation, sponsored by Fondazione Don Carlo Gnocchi ETS. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Fondazione Don Carlo Gnocchi ETS · Not applicable, Interventional, and Other
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.
112 studies on the registry are indexed under Amputation, Traumatic; 24 are open to participants now.
This study's enrollment of 8 is below the median of 15 across 75 interventional studies indexed under Amputation, Traumatic.
Browse Amputation, Traumatic studies →Fondazione Don Carlo Gnocchi ETS is the lead sponsor of 43 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: prototype prosthetic group
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.
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Fondazione Don Carlo Gnocchi ETS