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

Summary

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.

Conditions

• Stroke
• Amyotrophic Lateral Sclerosis
• PARKINSON DISEASE (Disorder)
• Mild Cognitive Impairment (MCI)

Interventions

DEVICE

Auto-calibrating System for Upper Limb disability Assessment, neurological and occupational Rehabilitation

Participants 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.

OTHER

conventional therapy

Participants 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.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA

  collaborator OTHER

• University of Pavia

  lead OTHER

Principal Investigators

• Antonella Ferrara, PhD · University of Pavia

• Cira Fundarò, MD · Istituti Clinici Scientifici Maugeri SpA

Study Design

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2026-07-31

Completion

2026-10-31