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

NCT ID: NCT07199322

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-12-31

Brief 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.

Detailed Description

The CO-AIDER study is a multicenter, randomized, controlled, two-arm, non-profit clinical trial validating an AI-based decision support system (AI-DSS) in robotic upper limb rehabilitation for stroke patients. It supports therapists in setting therapy parameters and personalizing rehabilitation programs while monitoring patient progress. A total of 100 participants with ischemic or hemorrhagic stroke in the subacute phase (within six months of the event) will be randomly assigned to two groups. The experimental group will receive upper limb robotic rehabilitation using the MOTORE device supported by the AI-DSS CO-AIDER, which predicts motor recovery and provides recommendations for optimal therapy parameters based on clinical and instrumental data. Recommendations focus on stiffness, weight, and viscosity, key parameters for tailoring therapy to patients' abilities. The system provides guidance only and does not directly affect therapy progression. The control group will receive the same robotic treatment, with parameters set by therapists based on their clinical expertise. All participants will complete 30 sessions of robotic rehabilitation, 45 minutes per day, five days per week, alongside a conventional rehabilitation program for lower limbs and trunk. Assessments will be performed at baseline (T0, within 7 days of enrollment), mid-treatment (T1, after 15 sessions), and at the end of treatment (T2, after 30 sessions). Clinical assessment will include measures of upper limb motor function, activities of daily living, pain, spasticity, cognitive function, and quality of life using standardized clinical scales. Robotic performance will be assessed using parameters collected by the MOTORE system. Usability and acceptability of the AI-DSS will be evaluated through validated questionnaires. Randomization will be stratified by disease onset, motor impairment, and recruitment center to ensure balanced allocation. Data will be collected and stored pseudonymously in a secure, encrypted database. A cost-effectiveness analysis will compare AI-DSS-supported rehabilitation with therapist-guided therapy. The study will also evaluate how patients and clinical staff perceive the AI-supported robotic system in routine rehabilitation.

Conditions

Stroke; Stroke Ischemic; Stroke Hemorrhagic; Upper Limb Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Robotic treatment with an AI-based decision support system (Robotic therapy + CO-AIDER software)

Participants assigned to this arm will receive upper limb robotic treatment using the MOTORE robotic device, supported by the AI-based decision support system (CO-AIDER software). CO-AIDER implements a predictive model based on recurrent neural networks (LSTM) that analyzes demographic, clinical, and kinematic data collected during treatment sessions. The model estimates the expected post-treatment scores on three standard clinical scales (FMA, ARAT, and MI). In addition to outcome prediction, the system provides therapists with recommendations on robot parameters (stiffness, weight, and viscosity), which are used to personalize the difficulty level of the exercises implemented in MOTORE, without directly altering the therapeutic course.

Group Type: EXPERIMENTAL

Robotic upper limb rehabilitation in patients with Stroke with AI support

Intervention Type: DEVICE

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.

Robotic treatment with parameters defined exclusively by the clinical team (Robotic Therapy)

Participants assigned to the control group will receive upper limb robotic treatment using the MOTORE robotic device. The treatment will be identical to the experimental arm in terms of device and exercise types, but all parameters will be determined exclusively by the physiotherapists based on their clinical expertise, without AI-based decision support.

Group Type: ACTIVE_COMPARATOR

Robotic upper limb rehabilitation in patients with Stroke without AI support

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

RT + COAIDER; Robotic Therapy + COAIDER; Robotic Therapy; RT

Eligibility Criteria

Inclusion Criteria

• Diagnosis of ischemic or hemorrhagic stroke confirmed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI);
• Age between 18 and 85 years;
• Time since stroke less than six months;
• Mild to severe upper limb impairment (Fugl-Meyer Assessment for Upper Extremity (FMA-UE) ≤ 58).

Exclusion Criteria

• Behavioral or cognitive disorders and/or reduced compliance;
• Severe spasticity or hypertonia in the affected limb (Modified Ashworth Scale (MAS) > 3);
• Severe visual impairments;
• Concurrent participation in another clinical trial for upper limb rehabilitation following stroke;
• Refusal to provide written informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Campus Bio-Medico

OTHER

Sponsor Role: collaborator

Scuola Superiore Sant'Anna di Pisa

OTHER

Sponsor Role: collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eugenio Guglielmelli, PhD

Role: STUDY_CHAIR

Campus Bio-Medico University

Irene G Aprile, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Don Carlo Gnocchi ONLUS, Roma

Locations

Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo

Sant'Angelo dei Lombardi, AV, Italy

Fondazione Don Carlo Gnocchi, Centro Spalenza

Rovato, BS, Italy

IRCSS Fondazione Don Carlo Gnocchi

Florence, FI, Italy

Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo

Tricarico, Mount, Italy

Scuola Superiore Sant'Anna

Pisa, PI, Italy

Fondazione Don Carlo Gnocchi, Centro Gala

Acerenza, PZ, Italy

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, RM, Italy

Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza

Roma, RM, Italy

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

La Spezia, SP, Italy

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

Torino, TO, Italy

Countries

Italy

Central Contacts

Irene G Aprile, MD, PhD

Role: CONTACT

iaprile@dongnocchi.it

+390633086500

Facility Contacts

Irene G Aprile, MD, PhD

Role: primary

iaprile@dongnocchi.it

+390633086500

References

Mehrholz J, Pohl M, Platz T, Kugler J, Elsner B. Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2018 Sep 3;9(9):CD006876. doi: 10.1002/14651858.CD006876.pub5.

Reference Type: BACKGROUND

PMID: 30175845 (View on PubMed)

Germanotta M, Cruciani A, Pecchioli C, Loreti S, Spedicato A, Meotti M, Mosca R, Speranza G, Cecchi F, Giannarelli G, Padua L, Aprile I. Reliability, validity and discriminant ability of the instrumental indices provided by a novel planar robotic device for upper limb rehabilitation. J Neuroeng Rehabil. 2018 May 16;15(1):39. doi: 10.1186/s12984-018-0385-8.

Reference Type: BACKGROUND

PMID: 29769127 (View on PubMed)

Aprile I, Germanotta M, Cruciani A, Loreti S, Pecchioli C, Cecchi F, Montesano A, Galeri S, Diverio M, Falsini C, Speranza G, Langone E, Papadopoulou D, Padua L, Carrozza MC; FDG Robotic Rehabilitation Group. Upper Limb Robotic Rehabilitation After Stroke: A Multicenter, Randomized Clinical Trial. J Neurol Phys Ther. 2020 Jan;44(1):3-14. doi: 10.1097/NPT.0000000000000295.

Reference Type: BACKGROUND

PMID: 31834217 (View on PubMed)

Other Identifiers

RF-2021-12375472

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

COAIDER

Identifier Type: -

Identifier Source: org_study_id