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The CYBERnetic LowEr Imb coGnitive Ortho-prostheis Plus Plus, 2nd Clinical Study (CLs++)

NCT04129853 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-05-28

No results posted yet for this study

Summary

The aim of the project is to evaluate the efficacy of the Cyberlegs X-leg in people with a unilateral transfemoral (above the knee joint) and transtibial (under the knee joint) amputation. De Cyberlegs X-leg is in continuation of the development of the Cyberlegs gamma-prototype (B.U.N. 143201732970; FAMHP reference number: 80M0725). The Cyberlegs X-leg is a motorized prosthesis which replaces the amputated part of the leg. Our hypothesis is that people with a lower limb amputation perform daily activities (e.g. walking, stair climbing, sit to stand, et cetera) easier, more comfortable and more efficient with the X-leg compared to their current prosthesis. Assessments will be based on a holistic approach in which biomechanical, physiological and psychological parameters are determined.

Conditions

  • Lower Limb Amputation Above Knee (Injury)

Interventions

DEVICE

Cyberlegs Xleg

Sit to stand, Stair Climbing, Slope walking, L-test, Hallway walking with the current vs. cyberlegs xleg and cyberlegs vs power knee

Sponsors & Collaborators

  • Össur Iceland ehf

    collaborator INDUSTRY

  • University of Ljubljana

    collaborator OTHER

  • Université Catholique de Louvain

    collaborator OTHER

  • Scuola Superiore Sant'Anna di Pisa

    collaborator OTHER

  • Fondazione Don Carlo Gnocchi Onlus

    collaborator OTHER

  • Vrije Universiteit Brussel

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-01-02
Primary Completion
2020-08-01
Completion
2020-12-31

Countries

  • Belgium

Study Locations

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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 NCT04129853 on ClinicalTrials.gov