Clinical Evaluation of Intuitive, Bidirectional Strategies for the Control of Multi-articulated Prostheses for Upper Limb Amputation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorScuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

About this trial

The investigators propose to validate a non-invasive upper limb prosthesis capable of combining: 1) intuitive movement control through machine learning applied to myoelectric signals, and 2) vibrotactile sensory feedback in response to touch and object release events. The prosthesis is composed at the minimum of skin-surface electrodes for myoelectric signals, vibrotactile actuators, a multi-articulated and instrumented hand prosthesis and a centralized control system. Such system is validated for several weeks in non-supervised environments.

Eligibility criteria

Qualifiers

subjects with transradial amputation, and minimum experience in the use of myoelectric prosthesis;

subjects who have expressed informed consent to participate in the study and consent to data processing.

Disqualifiers

subjects with obvious visual and oculomotor defects;

concomitant comorbidities/disabilities/chronic conditions, general or localized (Multiple Sclerosis, Parkinson's disease, muscle tone disorders, malignant neoplasms, etc.), which may interfere with the performance of the study;

pregnancy or breastfeeding;

declared or evident cognitive deficits that compromise the understanding of the required tasks (mini Mental State Examination≤ 24);

Trial design

Treatments tested in this trial

  • Prosthetic controller

Treatment groups

14 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Lead sponsor

IRCCS Istituto Ortopedico Rizzoli di Bologna

Collaborator