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Finished

Study on the Functionality, Safety and Reliability of a Robotic Prosthesis for the Lower Limb At the Transfemoral Level

NCT06284005 · Fondazione Don Carlo Gnocchi ETS · Updated 19 Sept 2024

What is being tested
WRL ATP
For
Amputation; Traumatic Amputation; Leg Injury; Lower Limb Injury
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 4 people. The full rules are on the registry page.
Where
Italy
When
Starts or started 27 July 2020, ends 22 Dec 2022. Registered 28 Feb 2024.
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-femoral 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.
ClinicalTrials.gov, NCT06284005

Sites

  • IRCCS Fondazione Don Carlo GnocchiFlorence, FI, Italy