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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Southampton Hand Assessment Procedure (SHAP) [Срок оценки: Measured at the baseline with the clinical prosthesis already in use (if any), then measured at the first and last week of each home-trial. Lastly, measured again after at least 1 wash-out week from the last home-trial]
• Clothespin Relocation Test (CRT) [Срок оценки: Measured at the baseline with the clinical prosthesis already in use (if any), then measured at the first and last week of each home-trial. Lastly, measured again after at least 1 wash-out week from the last home-trial]
• Pick and Lift Test (PLT) [Срок оценки: Measured at the baseline with the clinical prosthesis already in use (if any), then measured at the first and last week of each home-trial. Lastly, measured again after at least 1 wash-out week from the last home-trial]
• Virtual Egg Test (VET) [Срок оценки: Measured at the baseline with the clinical prosthesis already in use (if any), then measured at the first and last week of each home-trial. Lastly, measured again after at least 1 wash-out week from the last home-trial]
• Usage of the prosthesis [Срок оценки: Usage data will be recorded by the prosthesis during the two 4 weeks home-trials]

Вторичные конечные точки (6)

• NASA-TLX questionnaire [Срок оценки: Administered after each functional test (primary outcomes). Measured at the baseline with the clinical prosthesis already in use (if any), then measured at the first and last week of each home-trial. Lastly, measured again at the end of the study]
• abilHAND-ULA [Срок оценки: Administered before, after and at each week of the two home-trials]
• OPUS-UEFS [Срок оценки: Administered before, after and at each week of the two home-trials]
• TAPES [Срок оценки: Administered before, after and at each week of the two home-trials]
• QuickDASH [Срок оценки: Administered before, after and at each week of the two home-trials]
• SUS [Срок оценки: Administered before, after and at each week of the two home-trials]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• IRCCS Istituto Ortopedico Rizzoli — Bologna

Идентификаторы

NCT: NCT06886295 · IOR2024FIT4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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