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

Amputation Clinical Trial

— MOTU-ATP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06284005
• Other study ID #: MOTU ATP - Studio clinico
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Amputation
• Amputation, Traumatic
• Amputation; Traumatic, Leg, Lower

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