Accuracy of AuReha for Measuring Upper Limb Movements Compared to "Usual Care". Clinical Investigation in Healthy Volunteers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- The equivalence of AuReha compared to "Usual Care" (goniometer-based system) in measuring the shoulder's medio-lateral range of motion angle (abduction).
研究概览
简要总结
The clinical investigation design involves a validation study conducted on a group of healthy volunteers.
It is an interventional, monocentric study with a paired data design, aimed at verifying the equivalence of the AuReha system compared to the usual care system (goniometer) in the measurement of biomechanical parameters.
In addition to the measurements taken with AuReha and the goniometer, additional data collection will be carried out using the Kinovea system, which involves video analysis of recorded movement and has demonstrated high accuracy.
The validation on healthy volunteers will be conducted at the Laboratory of Movement and Sport Science (LaMSS) of the IRCCS Ospedale Galeazzi-Sant'Ambrogio in Milan, and will include the recruitment of 96 volunteers from among the hospital's internal staff.
详细描述
The primary objective of the clinical investigation is to obtain CE certification for the device.
Specifically, the project aims to document the accuracy of motion measurements detected by AuReha by comparing them with the most commonly used system in current "usual care" for upper limb rehabilitation: the goniometer. At the same time, the investigation will assess the correct and timely transmission of data collected by the AuReha device within the standalone software platform, which is composed of two main functional modules: one for the subject/patient and one for healthcare professionals.
These are the foundations for the optimal management of the rehabilitation process, resulting in a system capable of guiding the patient through the proper execution of rehabilitation movements as prescribed by the physician, while also collecting biomechanical parameters for close monitoring of the patient's response to the therapy.
In addition to the goal of certifying the AuReha system through evidence of motion measurement accuracy, the study will also include descriptive evaluations/objectives related to user experience and the usability/wearability of the smart shirt.
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
- 是
入选标准
- •Age > 18 years
- •Volunteers who provide written informed consent to participate in the study
- •Absence of movement limitations affecting the upper limbs and/or trunk
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
The equivalence of AuReha compared to "Usual Care" (goniometer-based system) in measuring the shoulder's medio-lateral range of motion angle (abduction).
时间窗: Day 1
The shoulder joint, also known as the glenohumeral joint, is a ball-and-socket type articulation formed by the head of the humerus and the glenoid cavity of the scapula. Flexion and extension are movements that occur around the coronal axis. Abduction and adduction are movements that occur around the sagittal axis. Abduction is a lateral movement ranging from 0° (arm perpendicular to the floor) to a vertical position above the head (approximately 180°). This final position is equivalent to that reached during flexion and involves the coordinated movement of the shoulder girdle and the glenohumeral joint.
次要结局
- Equivalence in the measurement of the shoulder and elbow flexion ranges of motion(Day 1)
- Characterization of AuReha in measuring movement smoothness and its timely and accurate transmission to the therapists' platform(Day 1)
- Characterization of AuReha in measuring movement accuracy and its timely and accurate transmission to the therapists' platform(Day 1)
- Characterization of AuReha in measuring trunk stability and its timely and accurate transmission to the therapists' platform(Day 1)
- Characterization of AuReha in measuring limb compensation and its timely and accurate transmission to the therapists' platform(Day 1)
- Characterization of AuReha in measuring the percentage of correct movements executed by the subject, and its timely and accurate transmission to the therapists' platform(Day 1)
- Correlation between AuReha shirt size (categorical: XS, S, M, L,) and the anthropometric measurements of healthy volunteers (in cm)(Day 1)
- Characterization of AuReha in terms of usability for healthy volunteers(Day 1)
- Characterization of AuReha in terms of usability for healthcare professionals(Day 1)