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The CYBERnetic Lower Limb Cocognitive Ortho-prosthesis Plus Plus, 1st Clinical Study (CLs++)

NCT03376919 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-12-27

No results posted yet for this study

Summary

The aim of the study is to assess the efficacy and the usability of the cyberlegs ++ ortho prosthesis to improve the mobility and the quality of life in transfemoral amputees . This research focusses on the physical and mental effort needed in locomotion-related tasks and human robot interaction in transfemoral amputees using a novel active prosthesis. This is an international project and foresees 2 clinical studies aimed at assessing the efficacy of the CLs++ modules in different settings.

In this first clinical study, 16 patients with unilateral trans-femoral amputation, 8 at the Vrije Universiteit Brussel Department Human Physiology Research group (VUB-MFYS) and 8 at the Don Gnocchi Foundation, center of Florence.

Conditions

  • Lower Limb Amputation Above Knee (Injury)

Interventions

DEVICE

CLs++ gait training

CLs++ gait training

Sponsors & Collaborators

  • Fondazione Don Carlo Gnocchi Onlus

    collaborator OTHER

  • Scuola Superiore Sant'Anna di Pisa

    collaborator OTHER

  • Université Catholique de Louvain

    collaborator OTHER

  • University of Ljubljana

    collaborator OTHER

  • Össur Iceland ehf

    collaborator INDUSTRY

  • Vrije Universiteit Brussel

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2018-01-01
Completion
2021-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03376919 on ClinicalTrials.gov