Intelligent Robot-mediated Therapy With the MOTORE Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Likert for Satisfaction
研究概览
简要总结
Stroke is a common disease with a high disabling impact; it is the world's second leading cause of death and the third leading cause of disability. Robotic therapy has been proposed as a viable approach for the rehabilitation of the upper limb, as a way to increase the amount and the intensity of the therapy, and to standardize the treatment. However, robotic technologies have not yet been used to their full potential in terms of tailoring rehabilitation paths and monitoring the response to treatments. The main goal of the study is to use AI algorithms to (a) predict the recovery of the patients and (b) suggest exercises and parameters to improve the outcomes of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first ischemic or hemorrhagic stroke (verified by MRI or CT);
- •time since stroke onset between 1 and 6 months (subacute phase)
- •cognitive abilities adequate to understand the experiments and the follow instructions
- •upper limb impairment (Fugl-Meyer Assessment - Upper Extremity score ≤58);
排除标准
- •fixed contractions in the affected limb (ankylosis, Modified Ashworth Scale equal to 4);
- •inability to understand the instructions required for the study;
- •behavioral disorders that may influence therapeutic activity;
- •other orthopedic or neurological diseases
- •inability or unwillingness to provide informed consent.
研究组 & 干预措施
Robotic group
In the robotic group, patients will undergo a 30-session upper limb robotic rehabilitation using the device MOTORE.
干预措施: AI-based upper limb robotic therapy (Device)
结局指标
主要结局
Likert for Satisfaction
时间窗: After a 6-week robotic rehabilitation intervention
Satisfaction will be assessed using a 11-point likert scale. It ranges from 0 to 10. Higher scores mean higher satisfaction.
Agreement between the physiotherapists and the decision support system
时间窗: Through the study, an average of 10 months
The number of times a physiotherapist refuses to accept the parameters proposed
System Usability Scale
时间窗: After a 6-week robotic rehabilitation intervention
It is a self-administered questionnaire to evaluate usability. It ranges from 0 to 100. Higher scores mean better usability.
Technology Acceptance Model (TAM)
时间窗: After a 6-week robotic rehabilitation intervention
It is a self-administered questionnaire to evaluate the acceptance of the provided. It comprises several questions rated on a 7-point likert scale.
次要结局
- Changes in Action Research Arm Test (ARAT)(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in Numeric Rating Scale for pain(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Change in Medical Research Council (MRC)(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Change in Modified Ashworth Scale(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in Fugl-meyer Assessment Upper Extremity motor functioning(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in Modified Barthel Index(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in 36-Item Short Form Survey (SF-36)(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in kinetic parameters: Force (N) towards 8 targets(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in Box and Block test (BBT)(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Change in Frenchay Arm Test(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in Motricity Index for upper extremity(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in Neuropathic Pain 4 Questions (DN4)(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in the Score Index.(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in the Duration Index.(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in Velocity_mean Index.(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in the Length_tot Index(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in the Work_tan Index.(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in Velocity_mean Index.(Before the intervention, after a 3-week robotic rehabilitation intervention)
- Changes in the Length_tot Index(Before the intervention, after a 3-week robotic rehabilitation intervention)
- Changes in the Work_tan Index.(Before the intervention, after a 3-week robotic rehabilitation intervention)
研究者
Irene Giovanna Aprile
Director of the Neurorehabilitation Department, Neurologist, Principal Investigator
Fondazione Don Carlo Gnocchi Onlus