Clinical trial NCT06886295: Clinical Evaluation of Intuitive, Bidirectional Strategies for the Control of Multi-articulated Prostheses for Upper Limb Amputation
Official title: Clinical Evaluation of Intuitive, Bidirectional Strategies for the Control of Multi-articulated Prostheses for Upper Limb Amputation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Upper Limb Amputation
Keywords: amputation
prosthesis
pattern recognition
regression
vibrotactile
sensory feedback
myoelectric
EMG
Lead sponsor: Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
Sponsor class: OTHER
Collaborators: name: IRCCS Istituto Ortopedico Rizzoli di Bologna
First posted: 2025-03-20
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model 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. Each condition will be assessed with a 4 weeks home-trial, separated by at least 1 wash-out week.

Each condition will dispose of a non-invasive upper limb prosthesis composed at the minimum of skin-surface electrodes for myoelectric signals, a multi-articulated and instrumented hand prosthesis, a vibrotactile actuator enabled at touch/release of the objects, and a centralized control system. The two conditions will differ based on the movement control strategy, machine learning based as opposed to conventional threshold control. The former tries to simplify the control of all degrees of freedom available by decoding intuitive muscular contraction at the residual limb. The latter applies simple thresholds to the myoelectric signals to provide sequential activations of all degrees of freedom available.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Southampton Hand Assessment Procedure (SHAP)
timeFrame: 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
measure: Clothespin Relocation Test (CRT)
timeFrame: 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
measure: Pick and Lift Test (PLT)
timeFrame: 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
measure: Virtual Egg Test (VET)
timeFrame: 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
measure: Usage of the prosthesis
timeFrame: Usage data will be recorded by the prosthesis during the two 4 weeks home-trials
Secondary outcomes:
measure: NASA-TLX questionnaire
timeFrame: 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
measure: abilHAND-ULA
timeFrame: Administered before, after and at each week of the two home-trials
measure: OPUS-UEFS
timeFrame: Administered before, after and at each week of the two home-trials
measure: TAPES
timeFrame: Administered before, after and at each week of the two home-trials
measure: QuickDASH
timeFrame: Administered before, after and at each week of the two home-trials
measure: SUS
timeFrame: Administered before, after and at each week of the two home-trials
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
state: Bo
Study officials:
References: