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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-27

Study Completion Date

2022-12-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Amputation Traumatic Amputation Leg Injury Lower Limb Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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prosthetic group

prosthetic group performs the entire protocol with the prosthesis prototype.

Group Type EXPERIMENTAL

WRL ATP

Intervention Type DEVICE

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

Interventions

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WRL ATP

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

Intervention Type DEVICE

Eligibility Criteria

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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