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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:
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 TTP | 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 feasability of the prosthesis and description of any adverse events. | baseline |
| ad hoc check-list Adverse Event | questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events. | day 2 |
| ad hoc check-list Adverse Event | questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events. | day 3 |
| ad hoc check-list Adverse Event | questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events. | day 4 |
| ad hoc check-list Adverse Event | questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events. | day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| CR-10 Borg Scale | 0-10 numerical rating scale that evaluate of the subjective perception of effort during walking | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Fondazione Don Carlo Gnocchi | Florence | FI | 50143 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18002631 | Background | Au SK, Herr H, Weber J, Martinez-Villalpando EC. Powered ankle-foot prosthesis for the improvement of amputee ambulation. Annu Int Conf IEEE Eng Med Biol Soc. 2007;2007:3020-6. doi: 10.1109/IEMBS.2007.4352965. | |
| 11807327 | Background | Buckley JG, O'Driscoll D, Bennett SJ. Postural sway and active balance performance in highly active lower-limb amputees. Am J Phys Med Rehabil. 2002 Jan;81(1):13-20. doi: 10.1097/00002060-200201000-00004. |
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| 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 | day 5 |
| 10mwt - 10 meters walking test | to assess the walking speed | day 2 |
| 10mwt - 10 meters walking test | to assess the walking speed | day 3 |
| SCT - stair climb test | to assess the capability of climb 8 stairs | day 2 |
| SCT - stair climb test | to assess the capability of climb 8 stairs | day 3 |
| TUG - Timed Up and GO | to assess lower limb capability | day 2 |
| TUG - Timed Up and GO | to assess lower limb capability | day 3 |
| 6mwt - 6 minute walking test on the treadmill | to assess the fatigue | day 4 |
| 6mwt - 6 minute walking test on the treadmill | to assess the fatigue | day 5 |
| Gait analisys | to assess the gait pattern | day 5 |
| Background | Borg, G. (1998). Borg's Perceived Exertion and Pain Scales. Human Kinetics. |
| Background | Brooke, J. (1996). SUS: a |
| 24122571 | Background | Cherelle P, Grosu V, Matthys A, Vanderborght B, Lefeber D. Design and Validation of the Ankle Mimicking Prosthetic (AMP-) Foot 2.0. IEEE Trans Neural Syst Rehabil Eng. 2014 Jan;22(1):138-48. doi: 10.1109/TNSRE.2013.2282416. Epub 2013 Oct 7. |
| Background | Eslamy, M., Grimmer, M., & Seyfarth, A. (2012). Effects of Unidirectional Parallel Springs on Required Peak Power and Energy in Powered Prosthetic Ankles: Comparison between Different Active Actuation Concepts. Proceedings of the 2012 IEEE International Conference on Robotics and Biomimetics, December 11-14, Guangzhou, China. |
| 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. |
| Background | Grimmer, M., & Seyfarth, A. (2014). Mimicking human-like leg function in prosthetic limbs. In Neurorobotics: from brain machine interfaces to rehabilitation robotics. Berlin: Springer. |
| Background | Grimmer, M., Eslamy, M., & Seyfarth, A. (2014). Energetic and Peak Power Advantages of Series Elastic Actuators in an Actuated Prosthetic Leg for Walking and Running. Actuators, 3:1-19. |
| 30530332 | Background | Huang S, Huang H. Voluntary Control of Residual Antagonistic Muscles in Transtibial Amputees: Reciprocal Activation, Coactivation, and Implications for Direct Neural Control of Powered Lower Limb Prostheses. IEEE Trans Neural Syst Rehabil Eng. 2019 Jan;27(1):85-95. doi: 10.1109/TNSRE.2018.2885641. Epub 2018 Dec 7. |
| 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. |
| Background | Marino, M., Pattni, S., Greenberg, M., Miller, A., Hocker, E., Ritter, S., et al. (2015). Access to prosthetic devices in developing countries: Pathways and challenges. 2015 IEEE Global Humanitarian Technology Conference (GHTC), 45-51. |
| 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. |