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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06284005
Other study ID # MOTU ATP - Studio clinico
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 27, 2020
Est. completion date December 22, 2022

Study information

Verified date February 2024
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-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.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date December 22, 2022
Est. primary completion date November 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - trans femoural amputation - Medicare Functional Classification Levels k3-k4 - expert prosthesis wearer (more than one year) - electronic knee prostheses user - energy-release prosthetic foot user Exclusion Criteria: - Relevant medical comorbidities - heart device wearers (PMK or AICD) - cognitive impairment - anxious or depressed illness

Study Design


Related Conditions & MeSH terms


Intervention

Device:
WRL ATP
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 (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary ad hoc check-list Adverse Event questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events. baseline
Primary ad hoc check-list Adverse Event questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events. day 2
Primary ad hoc check-list Adverse Event questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events. day 3
Primary ad hoc check-list Adverse Event questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events. day 4
Primary ad hoc check-list Adverse Event questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events. day 5
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