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

NCT ID: NCT06886295

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-12-31

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) 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.

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 The primary objective is to validate a non-invasive, transradial prosthesis that integrates the latest advancements for intuitive, bidirectional and multi-articulated control. This validation is intended to be conducted in unsupervised environments (i.e., home-use). The prosthesis under validation combines intuitive movement control through pattern recognition applied to myoelectric signals, and vibrotactile sensory feedback in response to touch and object release events.

The validation is conducted through well-established functional tests in the field designed to measure dexterity and motor coordination, and through data on daily usage.

Secondary Objectives The secondary objective is to validate the proposed prosthesis based on subjective assessments regarding user satisfaction, perceived capacity to control the device, and perceived level of disability.

Additionally, the study aims to assess whether participation in this research has any impact on the control of the clinically used prosthesis. To this end, both functional tests and self-assessment questionnaires will be used to evaluate the clinical prosthesis before and after the trial protocol.

Conditions

Upper Limb Amputation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

machine learning based prosthesis control

A non-invasive upper limb prosthesis whose control is facilitated through machine learning applied to myoelectric signals. The movements on the prosthesis are triggered by intuitive muscular contractions performed at the residual limb.

Group Type: EXPERIMENTAL

Prosthetic controller

Intervention Type: DEVICE

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.

conventional direct control

A non-invasive upper limb prosthesis whose control is enable by standard-in-care movement control strategy. The movements on the prosthesis are sequentially triggered through simple thresholds applied to myoelectric signals.

Group Type: ACTIVE_COMPARATOR

Prosthetic controller

Intervention Type: DEVICE

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.

Interventions

Prosthetic 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Istituto Ortopedico Rizzoli di Bologna

UNKNOWN

Sponsor Role: collaborator

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

OTHER

Sponsor Role: lead

Responsible Party

Christian Cipriani

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Istituto Ortopedico Rizzoli

Bologna, Bo, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Enzo Mastinu, MSc, BSc, PhD

Role: CONTACT

enzo.mastinu@santannapisa.it

0039 050 883111

Facility Contacts

Paolo Sassu, Medical Doctor, Surgeon, PhD

Role: primary

paolo.sassu@ior.it

0039 051 636 6111

Other Identifiers

IOR2024FIT4

Identifier Type: -

Identifier Source: org_study_id