Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prosthetic group performs the entire protocol with the prosthesis prototype. | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prototype prosthetic group | Device | 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:
Each session is expected to last approximately 2.5 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Ad hoc check list for Adverse Event | questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events. | baseline |
| Ad hoc check list for Adverse Event | questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events. | day 1 |
| Ad hoc check list for Adverse Event | questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events. | day 2 |
| Ad hoc check list for Adverse Event | questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events. | day 3 |
| Ad hoc check list for Adverse Event | questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events. | day 4 |
| Ad hoc check list for Adverse Event | questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events. | day 5 |
| Ad hoc check list for Adverse Event | questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events. | day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Borg Scale | 0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking. | day 1 |
| Borg Scale | 0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Fondazione Don Carlo Gnocchi | Florence | FI | 50143 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000673 | Amputation, Traumatic |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| day 2 |
| Borg Scale | 0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking. | day 3 |
| Borg Scale | 0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking. | day 4 |
| Borg Scale | 0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking. | day 5 |
| 10mwt - 10 meters walking test | to evaluate walking capacity measured in seconds | baseline |
| 10mwt - 10 meters walking test | to evaluate walking capacity measured in seconds | day 4 |
| 6mwt - 6 minutes walking test | to evaluate walking capacity measured in metres | 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. | day 6. |
| TUG - Time Up and Go | to assess lower limb capabilities in seconds | baseline |
| TUG - Time Up and Go | to assess lower limb capabilities in seconds | day 4 |
| SCT - Stair Climbing Test | to assess the capabilities of climb 8 stairs in seconds | baseline |
| SCT - Stair Climbing Test | to assess the capabilities of climb 8 stairs in seconds | day 4 |
| 6mwt - 6 minutes walking test | to evaluate walking capacity measured in metres | day 6 |
| FCT - Functional Reach Test | to assess the balance in centimeters | baseline |
| Functional Reach Test | to assess the balance in centimeters | day 5 |
| Cost of Transport -COT | To assess metabolic consumption | day 6 |