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Search / Trial NCT06886295

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

Launched by SCUOLA SUPERIORE DI STUDI UNIVERSITARI E DI PERFEZIONAMENTO SANT'ANNA · Mar 14, 2025

Trial Information

Current as of April 30, 2025

Recruiting

Keywords

Amputation Prosthesis Pattern Recognition Regression Vibrotactile Sensory Feedback Myoelectric Emg

ClinConnect Summary

This clinical trial is studying a new type of prosthetic arm designed for people who have lost part of their arm (specifically below the elbow). The goal is to create a prosthesis that allows for more natural and intuitive movement by using special sensors that pick up electrical signals from the muscles in the arm. It also includes a feature that provides feedback through gentle vibrations, helping users feel when they are touching or releasing objects. Participants will wear this prosthesis in their daily lives for several weeks to see how well it works.

To be eligible for the trial, participants should have a transradial amputation (meaning they have lost their arm below the elbow) and should have some experience using a myoelectric prosthesis, which is a prosthetic device that uses muscle signals to control movement. Participants must also understand Italian and be able to give their informed consent to join the study. This trial is open to individuals aged between 6 and 74, and it aims to improve the way prosthetic arms work, making daily tasks easier and more intuitive.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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.

About Scuola Superiore Di Studi Universitari E Di Perfezionamento Sant'anna

The Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna is a prestigious higher education institution located in Pisa, Italy, renowned for its commitment to excellence in research and education across various fields, including life sciences, social sciences, and engineering. As a clinical trial sponsor, Sant'Anna leverages its interdisciplinary expertise to advance innovative healthcare solutions and contribute to the scientific community. The institution fosters collaboration between academia and industry, ensuring that clinical trials are conducted with rigor and ethical standards, ultimately aiming to enhance patient outcomes and drive advancements in medical knowledge.

Locations

Bologna, Bo, Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported