Study on the Functionality, Safety and Reliability of a Robotic Prosthesis for the Lower Limb At the Transfemoral Level

NCT06284005 | Completed DMC

• 1 other identifier: MOTU ATP - Studio clinico
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation; Traumatic Amputation; Leg Injury; Lower Limb Injury

Keywords

lower limb; transfemoral

Outcome Measures

Primary Outcomes (5)

• ad hoc check-list Adverse Event

  questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.

  baseline

• ad hoc check-list Adverse Event

  questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.

  day 2

• ad hoc check-list Adverse Event

  questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.

  day 3

• ad hoc check-list Adverse Event

  questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.

  day 4

• ad hoc check-list Adverse Event

  questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.

  day 5

Study Arms (1)

prosthetic group

EXPERIMENTAL

prosthetic group performs the entire protocol with the prosthesis prototype.

Device: WRL ATP

Interventions

WRL ATP DEVICE

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

prosthetic group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Relevant medical comorbidities
• heart device wearers (PMK or AICD)
• cognitive impairment
• anxious or depressed illness

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi

Florence, FI, 50143, Italy

Location

Related 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.

  PMID: 18566923 BACKGROUND

• 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.

  PMID: 11392649 BACKGROUND

• 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.

  PMID: 25197716 BACKGROUND

• 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.

  PMID: 17436172 BACKGROUND

MeSH Terms

Conditions

Amputation, Traumatic; Leg Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• claudio macchi

  IRCCS Fondazione Don Carlo Gnocchi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: July 27, 2020
• Primary Completion: November 10, 2022
• Study Completion: December 22, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)