Effect of Personalized Robotic Therapy

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

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.

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