Upper Limb Robotic Rehabilitation During COVID-19 Outbreak

Study Overview
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Brief Summary
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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.

Detailed Description
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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) For Aim 3, at baseline, each patient will perform the kinematic and kinetic assessment provided by the robot twice, one day apart, to assess the reliability of the kinematic parameters provided by the robot; moreover, the kinematic and kinetics assessment will be performed every ten rehabilitation sessions, to analyze the responsiveness of the kinematic parameters and possible plateau in the recovery process.

Official Title
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Upper Limb Robotic Rehabilitation in Stroke Survivors Using a Portable Device During the COVID-19 Outbreak. A Feasibility Study

Conditions
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Stroke

Intervention / Treatment
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* Device: Robotic therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic therapy<br>Upper limb robotic rehabilitation by means of the portable robot Icone. | Device: Robotic therapy<br>* The treatment with the robot Icone will include 30 sessions, each session lasting 45 minutes, with a frequency from three to five times a week. The treatment will be provided in the patient's room. Patients will execute upper limb movement involving elbow flexion-extension, shoulder protraction-retraction, internal-external rotation, flexion-extension, and abduction-adduction. Visual and auditory feedback will be provided during the tasks. The exercises will train both motor and cognitive functions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Usability Scale (SUS) | It is a tool for measuring the usability | After 30 rehabilitation sessions | 
| Technology Acceptance Model (TAM) | It is a tool for measuring the acceptability. | After 30 rehabilitation sessions | 
| Likert Scale | It is a tool for measuring the satisfaction. | After 30 rehabilitation sessions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment for upper extremity (FMA-UE) | The Fugl-Meyer Assessment is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. | At baseline; after 30 rehabilitation sessions | 
| Motricity Index for the upper extremity (MI-UE) | It is a clinical instrument for characterizing the strength of the paretic upper extremity following stroke. | At baseline; after 30 rehabilitation sessions | 
| Modified Ashworth Scale (MAS) | It is a clinical instrument for characterizing upper limb spasticity. Shoulder, elbow and wrist spasticity will be assessed. | At baseline; after 30 session rehabilitation sessions | 
| Numeric Pain Rating Scale (NPRS) | It is a unidimensional measure of pain intensity in adults. | At baseline; after 30 rehabilitation sessions | 
| Modified Barthel Index (mBI) | It is a measure of independence in activities of daily living. | At baseline; after 30 rehabilitation sessions | 
| Montreal Cognitive Assessment (MoCA) | It is a widely used screening assessment for detecting cognitive impairment. | At baseline; after 30 rehabilitation sessions | 
| Kinematic parameters | The kinematics of the end-effector of the robot will be acquired during point-to-point tasks. | At baseline (twice, one day apart); after 10 rehabilitation sessions; after 20 rehabilitation sessions; after 30 rehabilitation sessions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, stroke, upper extremity, robotics