Finished
Interventional Study on the Evaluation of Functionality, Safety of a Robotic Prosthesis for Transtibial Amputations
NCT06161961 · Fondazione Don Carlo Gnocchi ETS · Updated 8 Dec 2023
- What is being tested
- WRL TTP
- For
- Amputation; Amputation; Traumatic, Leg, Lower
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years to 75 years. About 7 people. The full rules are on the registry page.
- Where
- Italy
- When
- Starts or started 21 July 2020, ends 22 Dec 2022. Registered 8 Dec 2023.
- Results
- None posted yet.
In the researchers' words
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: * Is to verify the technical functionality, safety and reliability of the propulsive lower limb prosthesis prototype, with active ankle, so as to provide indications regarding the technical and functional developments to be implemented in the finalization of the device. * Provide an indication of the functional effectiveness of the device and its satisfaction by patients. Participants will perform: * walking tests inside parallel bars on flat and/or inclined terrain; * walking tests on treadmill; * stair climbing/descent tests.
Sites
- IRCCS Fondazione Don Carlo GnocchiFlorence, FI, Italy