Clinical Evaluation of Intuitive, Bidirectional Strategies for the Control of Multi-articulated Prostheses for Upper Limb Amputation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Southampton Hand Assessment Procedure (SHAP)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Prosthetic controller (Device)
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.
干预措施: Prosthetic controller (Device)
结局指标
主要结局
Southampton Hand Assessment Procedure (SHAP)
时间窗: 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
The test consists of sequentially manipulating 6 lightweight and 6 heavyweight abstract objects and 14 activities of daily living over a specific formboard. Lightweight objects should be manipulated first. The task involves pushing a button to start a timer, picking up and moving the object from the rear slot to the front slot on the board, and completing the task by depressing the button on the timer again.
Clothespin Relocation Test (CRT)
时间窗: 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
The objective is to evaluate the performance of a prosthetic user in a controlled environment and subsequently provide a measure of the user's expected functionality level outside the laboratory/clinic. The user is instructed to allocate three clothespins between a horizontal rod and a vertical rod and asked to fill out a post-test survey after five trials of the CRT.
Pick and Lift Test (PLT)
时间窗: 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
The PLT measures motor coordination, i.e., the ability to coordinate the grip force and the load force while lifting an object, as well as the reliability of the recorded control signal while transporting the object. While the subject is sitting on a chair with the intact arm parallel to the trunk, and the amputated limb extending anteriorly on a table, he/she is asked to lift a small object from the table with the prosthesis.
Virtual Egg Test (VET)
时间窗: 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
The VET resembles the task of transporting fragile and robust objects, thus requiring both gross and fine dexterity. The test is composed of 11 Virtual Eggs that collapse if the grasping force exceeds their breaking thresholds, ranging from 0.4 N to 11.5 N. The test aims to transport each Virtual Egg over the barrier in the centre of the test platform without breaking it and as fast as possible. The metrics measured during the test are combined and provide two indexes that evaluate, respectively, gross and fine dexterity.
Usage of the prosthesis
时间窗: Usage data will be recorded by the prosthesis during the two 4 weeks home-trials
The prosthesis, for as long as it is powered, will log real-time information about its usage during the day. Such data will allow us to calculate the total wear/use time, as well as the quality of the usage (which moments are used and how often). The data should also provide basic information for debugging in case of system failures and adverse events.
次要结局
- abilHAND-ULA(Administered before, after and at each week of the two home-trials)
- SUS(Administered before, after and at each week of the two home-trials)
- OPUS-UEFS(Administered before, after and at each week of the two home-trials)
- TAPES(Administered before, after and at each week of the two home-trials)
- QuickDASH(Administered before, after and at each week of the two home-trials)
- NASA-TLX questionnaire(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)
研究者
Christian Cipriani
Full Professor
Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna