Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-28 @ 1:10 AM
Study NCT ID:
NCT06886295
Status:
RECRUITING
Last Update Posted:
2025-04-03
First Post:
2025-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Intuitive, Bidirectional Strategies for the Control of Multi-articulated Prostheses for Upper Limb Amputation
Sponsor:
Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
Organization:
Study Overview
Official Title:
Clinical Evaluation of Intuitive, Bidirectional Strategies for the Control of Multi-articulated Prostheses for Upper Limb Amputation
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: