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

NANot yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
StrokeStroke IschemicStroke HemorrhagicUpper 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."

Trial Locations (10)

10133

Fondazione Don Carlo Gnocchi, Centro Santa Maria ai Colli - Presidio Sanitario Ausiliatrice, Torino

19125

Fondazione Don Carlo Gnocchi, Santa Maria dei Poveri Polo Riabilitativo del Levante ligure, La Spezia

25038

Fondazione Don Carlo Gnocchi, Centro Spalenza, Rovato

50143

IRCSS Fondazione Don Carlo Gnocchi, Florence

56127

Scuola Superiore Sant'Anna, Pisa

75019

Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo, Tricarico

83054

Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo, Sant'Angelo dei Lombardi

85011

Fondazione Don Carlo Gnocchi, Centro Gala, Acerenza

00128

Fondazione Policlinico Universitario Campus Bio-Medico, Roma

00166

Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza, Roma

All Listed Sponsors
collaborator

Fondazione Policlinico Universitario Campus Bio-Medico

OTHER

collaborator

Scuola Superiore Sant'Anna di Pisa

OTHER

lead

Fondazione Don Carlo Gnocchi Onlus

OTHER

NCT07199322 - Clinical validatiOn of an AI-based DEcision Support System for Robotic Upper Limb Rehabilitation in Patients With Stroke. A CO-AIDER Study. | Biotech Hunter | Biotech Hunter