Effect of Personalized Robotic Therapy

Study Overview
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Brief Summary
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The primary goal of this project is to test the safeness and clinical effectiveness of a novel exoskeleton for the upper limb (Arm Light Exoskeleton Rehab Station, ALEx RS) developed at Wearable Robotics srl, for the force assistance of stroke patients during robotic-rehabilitation. The secondary study aim is to design and test an automatic personalized robot-based upper limb motor rehabilitation protocol targeting the specific kinematic performance of each patient. Finally, the study also aims to define the neuro-biomechanical state of the patient and its evolution during the therapy by studying cortical signals and muscular synergies. This information will be used to improve the personalization of the robotic treatment by targeting not only the motor performance but also the cerebral and muscular activity of the patient. The study is longitudinally designed in order to test the safeness and clinical effectiveness of ALEx RS over time, and to monitor the clinical effectiveness of the automatic personalized robotic therapy from the beginning until the end of the treatment. Moreover, in order to estimate the long-term clinical effectiveness of the treatment, the assessment methods proposed in the clinical trial will be repeated one month after the end of the treatment.

Official Title
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Effect of an Automatic Personalized Robot-assisted Rehabilitation on Cortical Organization and Clinical Recovery After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: Arm Light Exoskeleton Rehab Station (ALEx RS)
* Device: Arm Light Exoskeleton Rehab Station (ALEx RS) - automatically personalized


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stroke patients right and left hand dominant cerebral lesion onset between 2-8 weeks able to participate in a session of about 30-60 minutes right-hemiplegic with at least 10° of motion in the treated joints (shoulder and elbow) age: more than 18 years old Exclusion Criteria: subjects with an active implantable device or wearing an active device (e.g., pacemakers, metallic objects in the brain, infusion pumps, etc.) persistent delirium or disturbed vigilance moderate or severe language comprehension deficits skull breach new stroke lesions during rehabilitation patients incapable of discernment subjects with reduced mobility due to previous injuries or abnormalities unrelated with the cerebral accident

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional therapy<br>The control group of patients will perform a conventional therapy without the use of the exoskeleton. The conventional therapy will consist in a traditional treatment of occupational therapy or physiotherapy without the use of the robotic device. The therapist will provide a specific conventional treatment comparable with the robotic treatment in terms of session time and therapeutic goals (i.e., 45 minutes per session, about 100, 150, 200 and 250 movements respectively for the first, second, third and fourth week). The level of difficulty of the exercises will be increased by the physiotherapist according to the degree of impairment of the patients. The muscle and cerebral activity during the execution of the conventional therapy could be acquired. | |
| Experimental: Traditional robotic rehabilitation with ALEx RS<br>The rehabilitative task will be constituted of 3D reaching movements covering a sphere of fourteen centimeter of radius in front of the patient. The initial rehabilitative task will be the same for all the patients belonging to this group and the workspace will be extended accordingly to the therapist evaluation during the following training sessions. In order not to bias the comparisons of the effects of the different rehabilitative treatments, the therapist assisting this group during the rehabilitation will be the same for all the subjects belonging to this group and he/she will not take part in the rehabilitative treatment of the other groups. Initially, the patients will execute reaching movements in different directions in the horizontal plane. If the therapist will evaluate that the movements have been sufficiently recovered, reaching movements in the other planes will be proposed. | Device: Arm Light Exoskeleton Rehab Station (ALEx RS)<br>* ALEx RS is a complete system specifically designed to support the rehabilitation of stroke patients. In particular, this system is equipped with a robotic arm exoskeleton conceived for the force assistance, integrated in a Virtual Reality system that allows implementing rehabilitative exercises highly interactive and engaging for the patients. It is proven that the use of this type of devices in rehabilitation can provide high intensive, repetitive, task specific, and interactive treatment of the impaired arm and an objective and reliable mean for monitoring patients' progress.<br>|
| Experimental: Automatic personalized robotic rehabilitation with ALEx RS<br> | Device: Arm Light Exoskeleton Rehab Station (ALEx RS) - automatically personalized<br>* ALEx RS is a complete system specifically designed to support the rehabilitation of stroke patients. In particular, this system is equipped with a robotic arm exoskeleton conceived for the force assistance, integrated in a Virtual Reality system that allows implementing rehabilitative exercises highly interactive and engaging for the patients. It is proven that the use of this type of devices in rehabilitation can provide high intensive, repetitive, task specific, and interactive treatment of the impaired arm and an objective and reliable mean for monitoring patients' progress. The movements to be performed by the patient are automatically decided by the exoskeleton.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluated through the number of adverse events |  | 2 years | 
| Efficacy evaluated through Fugl-Meyer |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of personalized therapy evaluated through Fugl-Meyer | The secondary outcome of the study is the evaluation of the differences on the outcome for a personalized vs a standard robotic rehabilitation | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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automatic, personalized, robotic therapy