Status:
RECRUITING
Clinical Evaluation of Intuitive, Bidirectional Strategies for the Control of Multi-articulated Prostheses for Upper Limb Amputation
Lead Sponsor:
Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
Collaborating Sponsors:
IRCCS Istituto Ortopedico Rizzoli di Bologna
Conditions:
Upper Limb Amputation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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) vibrotact...
Detailed Description
The investigators propose a pilot single-center study, randomized with crossover design to compare the intuitive control strategy with the standard-in-care direct control strategy. Primary Objectives...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06886295
Start Date
April 1 2025
End Date
December 31 2026
Last Update
April 3 2025
Active Locations (1)
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1
IRCCS Istituto Ortopedico Rizzoli
Bologna, Bo, Italy, 40136