Clinical trial NCT06284005: Study on the Functionality, Safety and Reliability of a Robotic Prosthesis for the Lower Limb At the Transfemoral Level
Official title: Multicentre Interventional Pilot Study on the Evaluation of the Functionality, Safety and Reliability of a New Robotic Prosthesis for the Lower Limb At the Transfemoral Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Traumatic Amputation
Leg Injury
Lower Limb Injury
Keywords: lower limb
transfemoral
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: ad hoc check-list Adverse Event
timeFrame: baseline
measure: ad hoc check-list Adverse Event
timeFrame: day 2
measure: ad hoc check-list Adverse Event
timeFrame: day 3
measure: ad hoc check-list Adverse Event
timeFrame: day 4
measure: ad hoc check-list Adverse Event
timeFrame: day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi
state: FI
Study officials:
affiliation: IRCCS Fondazione Don Carlo Gnocchi
name: claudio macchi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.