Robotic Telerehabilitation: Feasibility of a Robotic Treatment of the Upper Limb With Remote Supervision in Patients With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Likert for Satisfaction
研究概览
简要总结
The goal of the study is to investigate the feasibility and the effects of a home-based upper-limb rehabilitation treatment (based on teleconsulting, telemonitoring, and robotic telerehabilitation using the robot Icone and integrated sensors) in patients with stroke.
详细描述
Stroke is the second leading cause of death, the third leading cause of disability in the world and the leading cause of disability in the elderly. Rehabilitation treatment is a long and costly process, the effectiveness of which is supported by strong scientific evidence. In recent years, technology has spread to the rehabilitation field and, to date, the use of rehabilitation robotics, in addition to conventional treatment, is recommended by some stroke guidelines. The coronavirus pandemic has required a reorganization of rehabilitation services, but also an enhancement of technology as a tool in the rehabilitation field that can allow treatment in compliance with social distancing. Many scientific works have in fact confirmed the usefulness of these approaches to overcome the limits imposed by the pandemic, in particular for the treatment of disabilities in stroke patients.
The rehabilitation robot Icone (CE marked medical device, Class II-A, produced by Heaxel), is a device with certification for home use and therefore suitable for telerehabilitation. The proposed study aims to test the feasibility of rehabilitation treatment in a home setting based on a system of telecounseling, telemonitoring and robotic telerehabilitation using the robot Icone and integrated sensors for patients with stroke, to overcome the limits imposed by the COVID-19 pandemic.
Patients undergo robotic telerehabilitation treatment, carried out at home. The patient is supervised by a caregiver and, remotely, by a multidisciplinary team thanks to the use of webcams and sensors embedded in the robot. The evaluations, through clinical scales and instrumental evaluations, are carried out both in presence (at the enrollment and the end of the study) and remotely (before the first telerobotic rehabilitation session, in the middle and after the last telerobotic rehabilitation session). The study is included in the Regional Smart Specialization Strategy (S3 - Biorobotics for rehabilitation) for business & life continuity and co-financed by the European Union through LazioInnova
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
- •ischemic or hemorrhagic stroke (verified by MRI or CT);
- •time since stroke onset > 3 months
- •cognitive abilities adequate to understand the experiments and the follow instructions
- •upper limb impairment (Fugl-Meyer Assessment - upper extremity score ≤58);
- •presence of a caregiver to supervise the treatment
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.
结局指标
主要结局
Likert for Satisfaction
时间窗: After a 4-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.
Technology Acceptance Model (TAM)
时间窗: After a 4-week robotic rehabilitation intervention
It is a self-administered questionnaire to evaluate the acceptance of the provided intervention. It comprises several questions rated on a 7-point likert scale.
System Usability Scale
时间窗: After a 4-week robotic rehabilitation intervention
It is a self-administered questionnaire to evaluate usability. It ranges from 0 to 100. Higher scores mean better usability.
Changes in Fugl-meyer Assessment Upper Extremity motor functioning
时间窗: Before the intervention, after a 4-week robotic rehabilitation intervention
It is a stroke-specific, performance-based impairment index. It ranges from 0 (hemiplegia) to 66 points (normal).
Reliability of the remote evaluation of the Fugl-meyer Assessment Upper Extremity motor functioning (FMA)
时间窗: Before the intervention
The value of the FMA obtained by means of online observation of the patient will be assessed in terms of reliability with the value obtained by means of direct observation, using the Intraclass Correlation Coefficient.
次要结局
- Changes in Fugl-meyer Assessment - Sensory functioning(Before the intervention, after a 4-week robotic rehabilitation intervention)
- Changes in the Path Index [mm](Before the intervention, after a 4-week robotic rehabilitation intervention)
- Changes in Numeric Rating Scale for pain(Before the intervention, after a 4-week robotic rehabilitation intervention)
- Reliability of the remote evaluation of the Independence Index(Before the intervention)
- Reliability of the remote evaluation of the Movement Duration index(Before the intervention, after a 4-week robotic rehabilitation intervention)
- Reliability of the remote evaluation of the Path Index(Before the intervention, after a 4-week robotic rehabilitation intervention)
- Reliability of the remote evaluation of the Mean speed index(Before the intervention)
- Changes in Fugl-meyer Assessment Upper Extremity motor functioning(Before the intervention, after a 2-week robotic rehabilitation intervention)
- Changes in the Independence Index(Before the intervention, after a 4-week robotic rehabilitation intervention)
- Changes in the Mean speed index [m/s](Before the intervention, after a 4-week robotic rehabilitation intervention)
- Changes in the Smoothness index(Before the intervention, after a 4-week robotic rehabilitation intervention)
- Reliability of the remote evaluation of the Area Index(Before the intervention)
- Changes in the Area Index [m2](Before the intervention, after a 4-week robotic rehabilitation intervention)
- Changes in the Movement Duration index [t](Before the intervention, after a 4-week robotic rehabilitation intervention)
- Changes in the Peak speed index [m/s](Before the intervention, after a 4-week robotic rehabilitation intervention)
- Changes in the Hold index [m](Before the intervention, after a 4-week robotic rehabilitation intervention)
- Changes in the Displacement index [m](Before the intervention, after a 4-week robotic rehabilitation intervention)
- Reliability of the remote evaluation of the Peak speed index(Before the intervention)
- Reliability of the remote evaluation of the Smoothness index(Before the intervention)
- Reliability of the remote evaluation of the Hold index(Before the intervention)
- Reliability of the remote evaluation of the Displacement index(Before the intervention)
研究者
Irene Giovanna Aprile
Director of the Neurorehabilitation Department, Neurologist, Principal Investigator
Fondazione Don Carlo Gnocchi Onlus