SocIal ROBOTics for Active and Healthy Ageing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in acceptability of the SI-ROBOTICS system
研究概览
简要总结
The study was designed to test the acceptability of the Si-Robotics system in a group of 20 subjects with Parkinson's Disease at an early stage, during a rehabilitation treatment based on Irish dancing. Assessments will be performed at the baseline and at the end of the treatment.
详细描述
The study was designed to test the acceptability of the SI-ROBOTICS system in a group of 20 subjects with Parkinson's Disease at an early stage during a rehabilitation treatment.
The SI-ROBOTICS system is composed of multiple technological components with the aim of facilitating a rehabilitation program based on Irish dance and encouraging the execution of dance steps. The SI-ROBOTICS system consists of:
- ROBOTIC PLATFORM: a social robot that allows the monitoring of patients during sessions, moving around patients safely and, if necessary, intervening in their support.
- LET'S DANCE GAME: a component that allows users to enjoy the game sessions (setting up of therapy sessions by the therapist, presentation of tasks to the player and execution by the latter, display of feedback on the sessions).
- ENVIRONMENTAL AND WEARABLE SENSORS: this allows data to be collected on the patient's main clinical parameters (e.g. heart rate, respiratory rate, etc.). These data allow the therapist to know the patient's state during the execution of tasks and the AI reasoner component to have an additional level of information with which to adapt the planning of steps.
- AI REASONERS: this is the back-end of the Si-Robotics system, i.e. the "intelligent" component that allows the adaptation of the game sessions, based on the users' game performance and the data collected through the sensors. In this way it will be possible to dynamically customize the session according to the user's needs and abilities.
- ARTIFICIAL VISION SETTING: a commercial camera called Inter Real Sense (https://www.intel.it/content/www/it/it/architecture-and-technology/realsense-overview.html) will be installed in the experimental setting for the extraction of kinematic parameters, saved anonymously and locally on this computer. Also the robotic platform will be equipped with a RealSense camera and will be able to acquire kinematic parameters. To extract features of interest from the signals, proprietary skeleton tracking software of the Real Sense camera will be used, together with specially developed algorithms for feature extraction.
In addition, kinematic and performance parameters will be collected, which will be used by the physiotherapist to evaluate and plan subsequent sessions, and by the system to delineate the levels of difficulty of the exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capacity to consent;
- •Hoen and Yahr scale: 1-2 stage;
- •Functional Ambulation Category (FAC) ≥ 2;
- •Ranking scale score ≤ 3;
- •Stability of drug treatment for at least 1 month;
- •Geriatric Depression Scale 4-items ≤ 1;
- •Mini Mental State Examination ≥ 24;
- •Maintaining an upright posture ≥ 30''.
排除标准
- •History of syncopal episodes, epilepsy and vertigo not controlled pharmacologically;
- •Serious dysfunction of the autonomic system;
- •Severe behavioral syndromes not compensated by drugs;
- •Concurrent neurological and/or cardiac diseases;
- •Recent femur fracture
- •Chronic medium to severe pain affecting standing or walking.
结局指标
主要结局
Change in acceptability of the SI-ROBOTICS system
时间窗: change from baseline to 4 and 8 weeks after intervention commencement
Acceptability will be assessed using a 52-item questionnaire based on the unified theory of acceptance and use of technology (UTAUT) model. It's a standardized instrument for measuring the likelihood of success for new technology introductions and helps to understand the drivers of its acceptance. The questionnaire has 52 questions distributed in 4 key constructs: 1) performance expectancy, 2) effort expectancy, 3) social influence, and 4) facilitating conditions. Each question are based on a Likert-type 5-point scale ranging from 1 = strongly disagree to 5 = strongly agree. Increments are integers between 1 to 5.
次要结局
- Change in fear of falling(change from baseline to 4 and 8 weeks after intervention commencement)
- Change in physical performance(change from baseline to 4 and 8 weeks after intervention commencement)
- Change in walking speed(change from baseline to 4 and 8 weeks after intervention commencement)
- Change in mobility(change from baseline to 4 and 8 weeks after intervention commencement)
- Change in balance(change from baseline to 4 and 8 weeks after intervention commencement)
- Change in goal attainment scale(change from baseline to 4 and 8 weeks after intervention commencement)
- Change in quality of life(change from baseline to 4 and 8 weeks after intervention commencement)