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 living assessments using standardized clinical scales; Conventional rehabilitation therapy sessions; Robotic-assisted upper limb rehabilitation exercises, including task-oriented and trajectory-tracking activities (experimental group only); Monitoring of vital parameters and adverse events during device use; Final evaluation of usability, psychosocial impact, patient satisfaction, motor and cognitive outcomes, and safety.
Adult patients aged between 18 and 80 years.
Confirmed diagnosis of one of the following neurological conditions: stroke, Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), or Mild Cognitive Impairment (MCI).
Presence of upper limb motor impairment defined by QuickDASH scores ranging from 20 to 90.
Ability to understand and follow the study protocol instructions.
Patients with severe psychiatric disorders or cognitive impairments that interfere with the ability to complete cognitive tests and self-assessment scales.
Individuals unable to provide informed consent.
Subjects with moderate to severe cognitive impairment, defined by an ECAS score lower than 81.92 (ALS patients) or a MoCA score between 18 and 25.
Physical conditions significantly limiting upper limb use (e.g., severe concomitant orthopedic disorders affecting shoulder movement).
University of Pavia
Lead sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborator