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

Not Applicable

Completed

• Conditions: Amputation; Traumatic Amputation; Leg Injury; Lower Limb Injury
• Interventions: Device: WRL ATP

• Registration Number: NCT06284005
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-27
• Primary Completion: 2022-11-10
• Study Completion: 2022-12-22
• Status Verified: 2024-02
• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-02-27
• Last Update Submitted: 2024-02-27
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
prosthetic group	WRL ATP	prosthetic group performs the entire protocol with the prosthesis prototype.

Primary Outcome Measures

Name	Time	Method
ad hoc check-list Adverse Event	day 5	questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.

Trial Locations

Locations (1)

IRCCS Fondazione Don Carlo Gnocchi; 🇮🇹 Firenze, FI, Italy