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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:
Participants will perform:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prosthetic group | Experimental | prosthetic group performs the entire protocol with the prosthesis prototype. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WRL ATP | Device | evaluation of functionality, degree of safety and reliability of the lower limb prosthesis prototype |
|
| Measure | Description | Time Frame |
|---|---|---|
| ad hoc check-list Adverse Event | questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events. | baseline |
| ad hoc check-list Adverse Event | questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events. | day 2 |
| ad hoc check-list Adverse Event | questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events. | day 3 |
| ad hoc check-list Adverse Event | questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events. | day 4 |
| ad hoc check-list Adverse Event | questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events. | day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| claudio macchi | IRCCS Fondazione Don Carlo Gnocchi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Fondazione Don Carlo Gnocchi | Florence | FI | 50143 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18566923 | Background | Gailey R, Allen K, Castles J, Kucharik J, Roeder M. Review of secondary physical conditions associated with lower-limb amputation and long-term prosthesis use. J Rehabil Res Dev. 2008;45(1):15-29. doi: 10.1682/jrrd.2006.11.0147. | |
| 11392649 | Background | Mak AF, Zhang M, Boone DA. State-of-the-art research in lower-limb prosthetic biomechanics-socket interface: a review. J Rehabil Res Dev. 2001 Mar-Apr;38(2):161-74. |
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| ID | Term |
|---|---|
| D000673 | Amputation, Traumatic |
| D007869 | Leg Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| 25197716 | Background | Pirouzi G, Abu Osman NA, Eshraghi A, Ali S, Gholizadeh H, Wan Abas WA. Review of the socket design and interface pressure measurement for transtibial prosthesis. ScientificWorldJournal. 2014;2014:849073. doi: 10.1155/2014/849073. Epub 2014 Aug 13. |
| 17436172 | Background | Segal AD, Orendurff MS, Klute GK, McDowell ML, Pecoraro JA, Shofer J, Czerniecki JM. Kinematic and kinetic comparisons of transfemoral amputee gait using C-Leg and Mauch SNS prosthetic knees. J Rehabil Res Dev. 2006 Nov-Dec;43(7):857-70. doi: 10.1682/jrrd.2005.09.0147. |