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 (MOTU-ATP)

February 27, 2024 updated by: Claudio Macchi, Fondazione Don Carlo Gnocchi Onlus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • FI
      • Firenze, FI, Italy, 50143
        • IRCCS Fondazione Don Carlo Gnocchi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: prosthetic group
prosthetic group performs the entire protocol with the prosthesis prototype.
Device: WRL ATP
evaluation of functionality, degree of safety and reliability of the lower limb prosthesis prototype

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ad hoc check-list Adverse Event
Time Frame: baseline
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
baseline
ad hoc check-list Adverse Event
Time Frame: day 2
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
day 2
ad hoc check-list Adverse Event
Time Frame: day 3
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
day 3
ad hoc check-list Adverse Event
Time Frame: day 4
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
day 4
ad hoc check-list Adverse Event
Time Frame: day 5
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2020

Primary Completion (Actual)

November 10, 2022

Study Completion (Actual)

December 22, 2022

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOTU ATP - Studio clinico

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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