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

NCT07199322 | Not Yet Recruiting

• 2 other identifiers: COAIDERRF-2021-12375472
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 10

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.

Conditions

Stroke; Stroke Ischemic; Stroke Hemorrhagic; Upper Limb Rehabilitation

Keywords

Stroke; Upper limb rehabilitation; Artificial Intelligence; Robot-assisted therapy; AI-supported robotic system; AI-based decision support system; rehabilitation

Outcome Measures

Primary Outcomes (2)

• Usability and acceptability for therapists

  Evaluation of usability and acceptability for therapists will be conducted through ad hoc questionnaires and the System Usability Scale (SUS). The SUS is a standardized tool developed to assess the perceived usability of systems, devices, or services. It consists of 10 items rated on a 5-point Likert scale, covering aspects such as ease of use, complexity, and learnability. The SUS provides a global usability score ranging from 0 to 100, where higher scores indicate better usability.

  Baseline; during the study; within 48 hours from the end of the treatment

• Change from baseline in the Fugl-Meyer Assessment for the upper extremities - motor function (FMA-UE)

  The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The upper extremity motor function domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. It ranges from 0 (hemiplegia) to 66 (normal motor performance).

  Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session

Secondary Outcomes (14)

• National Institutes of Health Stroke Scale (NIHSS)

  Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session

• Motricity Index (MI)

  Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session

• Modified Ashworth Scale (MAS)

  Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session

• Douleur Neuropathique 4 (DN4)

  Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session

• Numerical Rating Scale for Pain (NRS)

  Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session

Study Arms (2)

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

EXPERIMENTAL

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.

Device: Robotic upper limb rehabilitation in patients with Stroke with AI support

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

ACTIVE COMPARATOR

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.

Device: Robotic upper limb rehabilitation in patients with Stroke without AI support

Interventions

Robotic upper limb rehabilitation in patients with Stroke with AI support 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.

Also known as: RT + COAIDER, Robotic Therapy + COAIDER

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

Robotic upper limb rehabilitation in patients with Stroke without AI support 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.

Also known as: Robotic Therapy, RT

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Fondazione Policlinico Universitario Campus Bio-Medico: collaborator
• Scuola Superiore Sant'Anna di Pisa: collaborator

Study Sites (10)

Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo

Sant'Angelo dei Lombardi, AV, 83054, Italy

Location

Fondazione Don Carlo Gnocchi, Centro Spalenza

Rovato, BS, 25038, Italy

Location

IRCSS Fondazione Don Carlo Gnocchi

Florence, FI, 50143, Italy

Location

Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo

Tricarico, Mount, 75019, Italy

Location

Scuola Superiore Sant'Anna

Pisa, PI, 56127, Italy

Location

Fondazione Don Carlo Gnocchi, Centro Gala

Acerenza, PZ, 85011, Italy

Location

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, RM, 00128, Italy

Location

Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza

Roma, RM, 00166, Italy

Location

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

La Spezia, SP, 19125, Italy

Location

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

Torino, TO, 10133, Italy

Location

Related Publications (3)

• 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.

  PMID: 30175845 BACKGROUND

• 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.

  PMID: 29769127 BACKGROUND

• 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.

  PMID: 31834217 BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eugenio Guglielmelli, PhD

  Campus Bio-Medico University

  STUDY CHAIR

• Irene G Aprile, MD, PhD

  Fondazione Don Carlo Gnocchi ONLUS, Roma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene G Aprile, MD, PhD

CONTACT

+390633086500; iaprile@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicenter, randomized, controlled, two-arm clinical study of a non-CE-marked medical device for non-commercial purposes. Participants will be randomly assigned to either robotic rehabilitation supported by the AI-DSS (software CO-AIDER) or robotic rehabilitation with treatment parameters set by clinical staff.

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 30, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2024-12

Locations

IT (10)