RecruitingNot ApplicableNCT06886295

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


Sponsor

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Enrollment

14 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

  • 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.

Exclusion Criteria5

  • 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);
  • difficulty in understanding the Italian language.

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Interventions

DEVICEProsthetic controller

The intervention includes an upper limb prosthesis composed at the minimum by skin-surface electrodes for myoelectric signals, a vibrotactile actuator, a multi-articulated and instrumented hand prosthesis and a centralized control system. The centralized prosthetic controller processes the myoelectric signals acquired at the residual limb to enable the movements on the multi-articulated prosthesis.


Locations(1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, Bo, Italy

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NCT06886295


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