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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06161961
Other study ID # MOTU TT - studio clinico
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 21, 2020
Est. completion date December 22, 2022

Study information

Verified date November 2023
Source Fondazione Don Carlo Gnocchi Onlus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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Study Design


Related Conditions & MeSH terms


Intervention

Device:
WRL TTP
evaluation of functionality, degree of safety and reliability of the lower limb prosthesis prototype

Locations

Country Name City State
Italy IRCCS Fondazione Don Carlo Gnocchi Firenze FI

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

References & Publications (14)

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Outcome

Type Measure Description Time frame Safety issue
Primary ad hoc check-list Adverse Event questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events. baseline
Primary ad hoc check-list Adverse Event questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events. day 2
Primary ad hoc check-list Adverse Event questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events. day 3
Primary ad hoc check-list Adverse Event questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events. day 4
Primary ad hoc check-list Adverse Event questionnaire that evaluate the device feasability of the prosthesis and description of any adverse events. day 5
Secondary CR-10 Borg Scale 0-10 numerical rating scale that evaluate of the subjective perception of effort during walking day 5
Secondary 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 baseline
Secondary 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
Secondary 10mwt - 10 meters walking test to assess the walking speed day 2
Secondary 10mwt - 10 meters walking test to assess the walking speed day 3
Secondary SCT - stair climb test to assess the capability of climb 8 stairs day 2
Secondary SCT - stair climb test to assess the capability of climb 8 stairs day 3
Secondary TUG - Timed Up and GO to assess lower limb capability day 2
Secondary TUG - Timed Up and GO to assess lower limb capability day 3
Secondary 6mwt - 6 minute walking test on the treadmill to assess the fatigue day 4
Secondary 6mwt - 6 minute walking test on the treadmill to assess the fatigue day 5
Secondary Gait analisys to assess the gait pattern day 5
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