Intrasubject Evaluation of Upper Limb Movement Precision Using the AuReha System in Individuals With Unilateral Motor Impairment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Evaluation of the intra-subject difference in movement accuracy during a target-reaching exercise proposed by the AuReha system, between the healthy limb and the limb affected by motor deficit
研究概览
简要总结
The clinical investigation is designed as a controlled, two-arm, intra-patient, non-randomized interventional study aimed at assessing the capabilities of the AuReha system in detecting upper limb movement precision in patients with unilateral proprioceptive impairment. The comparison will be conducted within the same subject, between the healthy limb and the impaired limb, through the execution of proprioceptive exercises in an open kinetic chain. The biomechanical parameters collected will include movement precision, trunk stability, compensatory movements, and joint range of motion. In addition to the quantitative analysis, qualitative data will also be collected regarding usability, wearability, and user experience of the system through questionnaires administered to both patients and healthcare professionals.
The study will be conducted at the Shoulder Team Outpatient Clinic in Forlì, enrolling approximately 52 patients.
详细描述
The primary goal of this clinical investigation is to support the CE certification process of the AuReha system, a wearable medical device designed for monitoring upper limb movement during rehabilitation.
Specifically, the study aims to assess the movement precision of the upper limb in individuals with unilateral motor impairment. The main objective is to compare, within the same individual, the movement accuracy of the healthy arm versus the impaired arm during a series of rehabilitation exercises guided by the AuReha system.
Secondary objectives include:
- Evaluating the usability of the AuReha system in clinical practice from the perspective of healthcare professionals using the Healthcare Systems Usability Scale (HSUS) and additional targeted questions.
- Assessing patients' user experience during proprioceptive exercises, through the System Usability Scale (SUS), the User Engagement Scale - Short Form (UES-SF), and other custom questions.
- Characterizing the wearability of the device by matching shirt sizes with patients' anthropometric measurements, using both direct observations and questionnaires.
- Analyzing the movement data collected during a specific reaching task prompted by the AuReha system, to gain deeper insight into the quality and precision of the movement performed.
These aspects aim to demonstrate the system's ability to support an optimized rehabilitation process. AuReha is designed to help patients perform their prescribed rehabilitation exercises correctly while collecting detailed biomechanical data. This allows clinicians to closely monitor the patient's response to therapy and make data-driven decisions throughout the recovery process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •patients with a healthy contralateral limb
- •patients affected by orthopedic shoulder conditions such as posterior instability, anterior instability, anterior Latarjet instability, adhesive capsulitis, or prostheses
- •age ≥18 years
- •patients who consent to participate in the study by signing the informed consent form
排除标准
- •Pregnant and/or breastfeeding women (verified through self-declaration)
- •Allergy or hypersensitivity to materials used in the medical device, specifically: polypropylene and lycra (fabric), nylon (integrated zipper), viscose and elastane (zipper integration fabric)
- •Chronic headache under treatment
结局指标
主要结局
Evaluation of the intra-subject difference in movement accuracy during a target-reaching exercise proposed by the AuReha system, between the healthy limb and the limb affected by motor deficit
时间窗: Day 1
Unit of measurement: Percentage (%) - Movement accuracy, expressed as a percentage, measures how precisely the patient performs the prescribed movements, by assessing the deviation of the executed movement from the ideal movement to be performed.
次要结局
- Characterization of AuReha in measuring limb compensation(Day 1)
- Characterization of AuReha in measuring the distance to a specified target(Day 1)
- Characterization of AuReha in terms of usability for patients with the System Usability Scale (SUS)(Day 1)
- Characterization of AuReha in measuring trunk stability(Day 1)
- Characterization of AuReha in measuring the duration of the movement(Day 1)
- Characterization of AuReha in terms of usability for patients with the User Engagement Scale - Short Form (UES-SF)(Day 1)
- Characterization of AuReha in terms of usability for patients(Day 1)
- Characterization of AuReha in terms of usability for healthcare professionals(Day 1)
- Correlation between AuReha shirt size (categorical: XS, S, M, L,) and the anthropometric measurements of healthy volunteers (in cm)(Day 1)