Rehabilitation Based on Hybrid Neuroprosthesis: Evaluation of the Feasibility, Functionality and Usability of the System in a Post-stroke Patient Population.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Feasibility score
研究概览
简要总结
The study is a pilot, multi-center, prospective, and open study to test feasibility, functionality and usability of a device defined as a hybrid neuroprosthesis.
详细描述
The ReHyb project, being oriented towards the development of a hybrid, modular, flexible and patient-specific upper-body hybrid neuro-prosthesis, potentially able to maximize the training efficacy during hospital stay as well as home-based rehabilitation or assistance during Activities of Daily Living (ADL), offering at the same time a pleasant user experience, has led to the development and integration of different modules in an attempt to adapt to the specific conditions of different patients. This goal has oriented the Consortium toward a participatory design (PD) and an ethics-by-design approach (EbD) that has been applied all along the execution of the project.
Under this perspective, two platforms have been developed and evaluated according to the following:
- Evaluation of platforms: The global evaluation of the ReHyb system and its two developed platforms, High Power Platform (HPP) and Low Power Platform (LPP). To meet this goal, a pilot, multicenter, prospective, and open study was defined to test feasibility, functionality and usability of the two platforms that constitute the hybrid neuro-prosthesis developed. A total of 24 post-stroke patients (12 per clinical site) were recruited during a time-span of 12 months for the evaluation of the ReHyb system. This number was considered sufficient for the statistical analysis to investigate the feasibility and usability of the platforms. Furthermore, the sample size is expected to allow for finding most of the usability problems.
When evaluating the ReHyb platforms in full and in their different module combinations, the ReHyb project has incorporated two different hardware devices: a stationary high powered device (ReHyb-HP) and a portable spring-loaded device (ReHyb-SL), which are both integrated with FES support. The software components include the control algorithms of the platforms, a training environment (e.g., the Rehabilitations Gaming System (RGS), a desktop Virtual Reality (VR) setup with gamified protocols for motor and cognitive rehabilitation), and the Digital Twin (e.g., the level of task difficulty and the amount of support will be adapted to the capabilities of the user).
The general scope of the studies herein presented is about evaluating the developed ReHyb System regarding its feasibility, functionality and usability rather than about evaluating any therapeutic effect of using the device. As a consequence, with a maximum duration of 3 weeks and five sessions of training per subject, the study participation is probably not long enough to expect therapeutic effects induced by the hybrid training. In fact, in previous studies, a minimum of four to seven weeks of intervention was required to detect significant clinical improvements in upper limb functions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (women or men aged ≥ 18 years)
- •with a diagnosis of stroke either hemorrhagic or ischemic
- •with a hemiparesis of the upper limb (0 ≤ MRC ≤ 4)
- •in sub-acute (up to six months after acute event) or chronic condition (more than 6 months from the acute event).
- •Able to sit upright for the duration of the test.
- •Subjects with a level of cognitive capacity that enables him/her to follow the instructions related to the performance of exercises.
排除标准
- •Subjects with a high level of spasticity (Modified Ashworth Scale: In general >3 except for motorized joints which may be >2)
- •Pain in the affected upper limb (Numeric Rating Scale > 4)
- •Severe psychiatric disorder
- •Permanent neurological symptoms present immediately before stroke
- •Physical conditions that can alter normal biomechanics (e.g., recent sprains or injuries, etc.)
- •Pregnant or nursing women
- •No written informed consent from the patient or the legal representative
- •Active implantable devices (e.g., pacemaker)
- •Unstable medical condition
结局指标
主要结局
Feasibility score
时间窗: Day 3 and Day 5
Feasibility score of the treatment is assessed through Intrinsic Motivation Inventory (IMI, 1-7 on a likert scale per each item)
Number of adverse Events
时间窗: from enrollment to end of treatment (up to 2 weeks).
Safety of the delivered treatment is assessed monitoring the number of Adverse Event (AE). The metric is the number of events.
Feasibiliy
时间窗: Day 3 and Day 5
Feasibiliy is evaluated with the User Experience Questionnaire (UEQ, -3 to 3 on a likert scale per each item) - short.
Number of adverse Events
时间窗: from enrollment to end of treatment (up to 2 weeks).
Safety of the delivered treatment is assessed monitoring the number of Adverse Event (AE). The metric is the number of events.
Usability
时间窗: Day 6
Perceived Usability of the device from the patients perspective. Assessed with System Usability Scale (SUS) scale questionnaire. The scale ranges from 0-100.
Feasibility score
时间窗: Day3 and Day5
Feasibility score is assessed by means of Unified Theory of Acceptance and Use of Technology questionnaire (UTAUT, 1-7on a likert scale per each item),
Usability
时间窗: Throughout the delivered treatment (up to 2 weeks).
Usability is assessed with donning and doffing time (measured in minutes).
Usability
时间窗: Day 3 and Day 5
Usability from the patient's perspective i evaluated with the Flow State Scale (FSS, 1-7 on a likert scale per each item)
次要结局
- Assistive Torques(From enrollment to the end of treatment (up to two weeks))
- Assistance Stimulation currents(Throughout the delivered therapy (up to two weeks).)
- Assistive Torques(From enrollment to the end of treatment (up to two weeks))
- Assistance Stimulation currents(Throughout the delivered therapy (up to two weeks).)
研究者
Dr. Franco Molteni
Medical Doctor
Villa Beretta Rehabilitation Center