Clinical validatiOn of an AI-based DEcision Support System for Robotic Upper Limb Rehabilitation in Patients With Stroke. A CO-AIDER Study.

Summary

The goal of this clinical trial is to validate an artificial intelligence-based decision support system (AI-DSS) for robotic rehabilitation in participants with stroke.

The study aims to answer the following questions:

* Can the AI-DSS support therapists in setting therapy parameters and adapting personalized robotic rehabilitation programs effectively?
* Can AI-supported robotic rehabilitation improve upper limb function, activities of daily living (ADL), cognitive function, and quality of life compared with standard therapist-guided robotic rehabilitation?

Researchers will compare two groups:

* Robotic rehabilitation supported by the AI-DSS (CO-AIDER);
* Robotic rehabilitation with parameters set by therapists (control group).

Participants will:

* Receive robotic rehabilitation for the upper limb, either guided by the AI-DSS or by therapists;
* Be monitored throughout the program, with therapy parameters adjusted according to their progress;
* Complete assessments to evaluate changes in upper limb function, activities of daily living, cognitive function, and quality of life.

The study will also evaluate the usability and acceptability of the AI-supported robotic system as perceived by participants and clinical staff, and will include a cost-effectiveness analysis of the two interventions.

Conditions

• Stroke
• Stroke Ischemic
• Stroke Hemorrhagic
• Upper Limb Rehabilitation

Interventions

DEVICE

Robotic upper limb rehabilitation in patients with Stroke with AI support

Participants will receive upper limb robotic treatment using MOTORE (Mobile robot for upper limb neurOrtho Rehabilitation), a medical device indicated for post-stroke and post-traumatic rehabilitation. MOTORE is a portable, autonomous, omnidirectional, haptic robot that provides force feedback to the user and supports active, passive, and assistive movements. The device includes software with assessment and rehabilitation exercises presented as interactive games (serious games), enabling personalized therapy and measurement of patient performance. MOTORE follows the "assist as needed" paradigm, actively assisting or resisting movements based on the patient's intentions. Parameters are set by the AI-based decision support system (CO-AIDER). Treatment will be delivered daily for 45 minutes, five days per week, for a total of 30 sessions.

DEVICE

Robotic upper limb rehabilitation in patients with Stroke without AI support

Participants will receive upper limb robotic treatment using MOTORE (Mobile robot for upper limb neurOrtho Rehabilitation), a medical device indicated for post-stroke and post-traumatic rehabilitation. MOTORE is a portable, autonomous, omnidirectional, haptic robot that provides force feedback to the user and supports active, passive, and assistive movements. The device includes software with assessment and rehabilitation exercises presented as interactive games (serious games), enabling personalized therapy and measurement of patient performance. MOTORE follows the "assist as needed" paradigm, actively assisting or resisting movements based on the patient's intentions. Parameters are set by the clinical team based on their expertise. Treatment will be delivered daily for 45 minutes, five days per week, for a total of 30 sessions.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Campus Bio-Medico

  collaborator OTHER

• Scuola Superiore Sant'Anna di Pisa

  collaborator OTHER

• Fondazione Don Carlo Gnocchi Onlus

  lead OTHER

Principal Investigators

• Eugenio Guglielmelli, PhD · Campus Bio-Medico University

• Irene G Aprile, MD, PhD · Fondazione Don Carlo Gnocchi ONLUS, Roma

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-30

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Italy

Study Locations