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

RecruitingNAAges 18 Years - 65 YearsAllScuola Superiore di Studi Universitari e di Perfe…
NCT06886295 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Prosthetic controller
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Where

1 site
IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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