Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06886295

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

Led by Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna · Updated on 2025-04-03

14

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

Sponsors

S

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Lead Sponsor

I

IRCCS Istituto Ortopedico Rizzoli di Bologna

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects with transradial amputation and minimum experience using a myoelectric prosthesis
  • Subjects who have given informed consent to participate and agree to data processing
Not Eligible

You will not qualify if you...

  • Subjects with obvious visual or eye movement defects
  • Presence of comorbidities or chronic conditions that may affect study performance (e.g., Multiple Sclerosis, Parkinson's disease, muscle tone disorders, malignant neoplasms)
  • Pregnancy or breastfeeding
  • Cognitive deficits affecting task understanding (mini Mental State Examination score  24)
  • Difficulty understanding the Italian language

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IRCCS Istituto Ortopedico Rizzoli

Bologna, Bo, Italy, 40136

Actively Recruiting

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Research Team

E

Enzo Mastinu, MSc, BSc, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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