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Auto-calibrating System for Upper Limb Disability Assessment, Neurological and Occupational Rehabilitation

University of Pavia · 2026
ClinicalTrials.gov · Datasets · License: Public Domain · 2026
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This interventional, multicenter, low-intervention clinical trial aims to evaluate the usability, feasibility, safety, and preliminary clinical impact of a robotic rehabilitation system designed for upper limb rehabilitation in adults with neurological disorders, including Parkinson's disease (PD), Amyotrophic Lateral Sclerosis (ALS), post-stroke sequelae, and Mild Cognitive Impairment (MCI). The system under study combines a collaborative robot (cobot), inertial sensors, and a graphical user interface capable of supporting reaching exercises, trajectory tracking activities, and cognitive exergames, while also enabling automatic acquisition and visualization of patient performance data. The main questions the study aims to answer are: Is the investigational robotic rehabilitation system usable and feasible in neurological patients undergoing upper limb rehabilitation? Is the use of the device safe for both patients and healthcare operators? Does the addition of robotic-assisted rehabilitation to conventional therapy improve upper limb motor performance, cognitive function, and quality of life compared with conventional rehabilitation alone? Do movement measurements collected by the system correlate with standard clinical assessment scales? Researchers will compare conventional rehabilitation therapy plus robotic-assisted rehabilitation with conventional rehabilitation therapy alone to evaluate the impact of the device on motor, cognitive, and psychosocial outcomes. Thirty participants will be randomized into two parallel treatment groups. Both groups will receive 12 sessions of conventional rehabilitation therapy lasting 60 minutes each, three times per week. Participants assigned to the experimental group will additionally receive robotic-assisted rehabilitation sessions of up to 30 minutes supervised by rehabilitation staff. Participants will undergo: Baseline collection of demographic and clinical information; Motor, cognitive, and activities of daily livi
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