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).
Parallel
Auto-calibrating System for Upper Limb disability Assessment, neurological and occupational Rehabilitation
DeviceParticipants will receive 12 sessions of conventional rehabilitation therapy (60 minutes each, three times per week) in addition to training sessions with the investigational robotic device. Device sessions will last up to 30 minutes and will be supervised by rehabilitation staff. The investigational robotic system provides adaptive upper limb rehabilitation exercises tailored to the patient's motor performance. Training includes task-oriented reaching exercises combined with cognitive tasks requiring target sequence memorization, as well as trajectory-tracking exercises in which the robot guides the patient's hand along predefined movements recorded by the therapist. Exercise difficulty is progressively adjusted according to patient performance during previous sessions.
conventional therapy
Other interventionParticipants will receive conventional rehabilitation therapy according to standard clinical practice for upper limb motor rehabilitation. Treatment sessions will last 60 minutes, three times per week, for a total of 12 sessions.
System Usability Scale (SUS) score
Usability of the investigational device will be assessed using the System Usability Scale (SUS). Minimum Value: 0. Maximum Value: 100. Interpretation: Higher scores indicate greater perceived usability and therefore a better outcome.
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) Score
Participant satisfaction and usability assessment using the QUEST 2.0 questionnaire. Minimum Value: 1 Maximum Value: 5 Interpretation: Higher scores indicate greater user satisfaction with the assistive technology and therefore a better outcome.
Incidence of Adverse Events
Safety assessment based on the frequency of adverse events reported by participants or observed by operators during device use.
State Trait Anxiety Inventory (STAI) score
Anxiety associated with device use assessed through self-reported scale, State Trait Anxiety Inventory (STAI). Scale Title: State-Trait Anxiety Inventory (STAI). Minimum Value: 20. Maximum Value: 80. Interpretation: Higher scores indicate greater anxiety and therefore a worse outcome.
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Assessment of upper limb disability and motor function using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. Scale Title: Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire Minimum Value: 0. Maximum Value: 100. Interpretation: Higher scores indicate greater disability and symptoms of the upper extremity and therefore a worse outcome.
Fugl-Meyer Assessment Score
Evaluation of upper limb motor performance using the Fugl-Meyer Assessment. Minimum Value: 0. Maximum Value: 226. Interpretation: Higher scores indicate better sensorimotor function and therefore a better outcome.
ABILHAND Scale Score
Assessment of manual ability in activities of daily living using the ABILHAND scale. Minimum Value: 0 . Maximum Value: Not strictly bounded. Interpretation: Higher scores indicate better perceived manual ability in performing daily activities and therefore a better outcome.
Action Research Arm Test (ARAT) Score
Evaluation of upper limb motor function using the Action Research Arm Test. Scale Title: Action Research Arm Test (ARAT) Minimum Value: 0. Maximum Value: 57. Interpretation: Higher scores indicate better upper limb function and dexterity and therefore a better outcome.
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University of Pavia
Lead sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborator
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