Upper Limb Robotic Rehabilitation in Stroke Survivors Using a Portable Device During the COVID-19 Outbreak. A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Technology Acceptance Model (TAM)
研究概览
简要总结
The COVID-19 outbreak requires a rapid re-shaping of the entire organization of the rehabilitation services. This includes the design and planning of appropriate rehabilitation settings, intervention and logistics for organizing space for patients.
The aims of this study are: (a) to evaluate the feasibility of the bedside use of a novel rehabilitation device for upper limb in patients with stroke; (b) to evaluate the motor and cognitive outcomes of the treatment; (c) to validate the instrumental outcomes provided by the device.
详细描述
This study aims to:
- evaluate the feasibility of the bedside use of a novel portable rehabilitation device for upper limb in patients with stroke in an inpatient setting;
- assess motor and cognitive outcomes of the treatment;
- validate the instrumental outcomes provided by the device.
Forty subacute stroke patients with upper limb hemiplegia will be enrolled. Patients' upper limb will be treated with a novel portable robotic device (Icone, Heaxel). The robot will be transferred to each patient's room, where the rehabilitation session will be performed, thanks to the portability of the device. During the treatment, patients will execute "exergames" involving elbow flexion-extension, shoulder protraction-retraction, internal-external rotation, flexion-extension and abduction-adduction. The exercises will be selected among the available ones to train both motor and cognitive functions. The rehabilitation intervention will include 30 rehabilitation sessions, each lasting 45 minutes, three to five times a week. In addition to the upper limb treatment, patients will receive a rehabilitation treatment for the lower limbs.
For Aim 1, the usability and the acceptability of the device and the satisfaction with the treatment will be evaluated at the end of the rehabilitation intervention by means of the System Usability Scale (SUS), the Technology Acceptance Model (TAM), and the Likert scale, respectively.
For Aim 2, the clinical effect of the treatment with the robot will be investigated by means of the following scales, assessed both at baseline and at discharge: the Fugl-Meyer Assessment for the upper extremity (FMA-UE), the Motricity Index (MI), the Modified Ashworth Scale (MAS), the Modified Barthel Index (mBI), the Numeric Pain Rating Scale (NPRS), and the Montreal Cognitive Assessment (MoCA)
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 latency within 6 months from stroke (subacute patients);
- •age between 35-85 years;
- •cognitive abilities adequate to understand the experiments and the follow instructions
- •upper limb impairment (FMA-UE score ≤58);
- •ability to give written consent;
- •compliance with the study procedures.
排除标准
- •history of recurrent stroke;
- •inability to understand the instructions required for the study;
- •fixed contractions in the affected limb (ankylosis, Modified Ashworth Scale equal to 4);
- •severe deficits in visual acuity.
结局指标
主要结局
Technology Acceptance Model (TAM)
时间窗: After 30 rehabilitation sessions
It is a tool for measuring the acceptability.
Likert Scale
时间窗: After 30 rehabilitation sessions
It is a tool for measuring the satisfaction.
System Usability Scale (SUS)
时间窗: After 30 rehabilitation sessions
It is a tool for measuring the usability
次要结局
- Montreal Cognitive Assessment (MoCA)(At baseline; after 30 rehabilitation sessions)
- Motricity Index for the upper extremity (MI-UE)(At baseline; after 30 rehabilitation sessions)
- Modified Ashworth Scale (MAS)(At baseline; after 30 session rehabilitation sessions)
- Fugl-Meyer Assessment for upper extremity (FMA-UE)(At baseline; after 30 rehabilitation sessions)
- Modified Barthel Index (mBI)(At baseline; after 30 rehabilitation sessions)
- Numeric Pain Rating Scale (NPRS)(At baseline; after 30 rehabilitation sessions)
- Kinematic parameters(At baseline (twice, one day apart); after 10 rehabilitation sessions; after 20 rehabilitation sessions; after 30 rehabilitation sessions)
研究者
Irene Giovanna Aprile
MD, PhD
Fondazione Don Carlo Gnocchi Onlus