The CYBERnetic LowEr-Limb CoGnitive Ortho-prosthesis Plus Plus, 1st Clinical Study

Summary

The global goal of the CYBERnetic LowEr-limb coGnitive ortho-prosthesis Plus Plus (CLs++) project is to validate the technical and economic viability of the powered robotic ortho-prosthesis developed within the 7th Framework Program - Information and Communication Technology - CYBERnetic LowEr-limb coGnitive ortho-prosthesis project, as a means to enhance/ restore the mobility of transfemoral amputees and to enable them to perform locomotion tasks such as ground-level walking, climbing/descending stairs, standing up, sitting down and turning in scenarios of real life. Restored mobility will allow amputees to perform physical activity thus counteracting physical and cognitive decline which occurs with advancing age and improving the overall health status and quality of life.

This project involves players from academia, research institutions, end users, as well as robotics and healthcare industry, and has been funded by the European Commission (call identifier H2020 - Information and Communication Technology 24-2015, scope c, namely Technology Transfer - Robotics use cases, Grant Agreement 731931).

The CLs++ project is an Innovation Action (IA) and foresees 2 clinical studies aimed at assessing the efficacy of the CLs++ modules in different settings.

In this 1st clinical study, 16 patients with unilateral trans-femoral amputation, 8 @ the Don Gnocchi Foundation, Center of Florence, and 8 @ the Free University of Brussels, Dept. of Human Physiology, will participate in the assessment of the efficacy of the CLs++ ortho-prosthesis modules in a clinical setting.

Conditions

• Transfemoral Amputation

Interventions

DEVICE

CLs++

Familiarization/training with the customized combination of the CLs++ ortho-prosthesis modules

Sponsors & Collaborators

• Scuola Superiore Sant'Anna di Pisa

  collaborator OTHER

• Université Catholique de Louvain

  collaborator OTHER

• Vrije Universiteit Brussel

  collaborator OTHER

• University of Ljubljana

  collaborator OTHER

• Össur Iceland ehf

  collaborator INDUSTRY

• IUVO Srl

  collaborator UNKNOWN

• Fondazione Don Carlo Gnocchi Onlus

  lead OTHER

Principal Investigators

• Raffaele Molino Lova, MD · Fondazione Don Carlo Gnocchi Onlus

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

30 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-26

Primary Completion

2019-12-20

Completion

2019-12-20

Countries

• Italy

Study Locations