CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 7 enrolled
Drug / intervention
WRL TTPdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06161961
NCT06161961N/ACompleted

Interventional Pilot Study on the Evaluation of Functionality, Degree of Safety and Reliability of a New Robotic Prosthesis for Treatment of Transtibial Lower Limb Amputations

Fondazione Don Carlo Gnocchi Onlus·interventional·Posted Dec 8, 2023·Updated Dec 8, 2023

In Brief

A clinical study evaluating WRL TTP for Amputation and Amputation; Traumatic, Leg, Lower. Completed, enrolled 7 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 8, 2023
Enrollment StartJul 21, 2020
Primary CompletionNov 10, 2022
Study CompletionDec 22, 2022
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 2.6 years ago

Interventions

WRL TTPdevice

evaluation of functionality, degree of safety and reliability of the lower limb prosthesis prototype