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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
100
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.
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.
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
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.
Time frame: 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).
Time frame: Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session
National Institutes of Health Stroke Scale (NIHSS)
The National Institutes of Health Stroke Scale (NIHSS) is a validated tool for assessing stroke severity. The score ranges from 0 to 42, with higher scores indicating more severe neurological deficit.
Time frame: Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session
Motricity Index (MI)
The Motricity Index (MI) is an ordinal method of measuring limb strength. For the upper extremity, shoulder abduction, elbow flexion, and pinch grip are considered; for the lower extremity, hip flexion, knee extension, and ankle dorsiflexion are considered. It ranges from 0 (worse) to 100 (normal strength).
Time frame: Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session
Modified Ashworth Scale (MAS)
The Modified Ashworth Scale (MAS) is a revised version of the original Ashworth Scale that measures spasticity in patients with lesions to the central nervous system. MAS is an assessment that is used to measure the increase in muscle tone. MAS assigns a grade of spasticity from a 0 to 4 ordinal scale. The grade is assigned by moving a joint/muscle through a high velocity quick stretch. The lower the score, the lower the spasticity. Upper and lower joints spasticity is assessed.
Time frame: Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session
Douleur Neuropathique 4 (DN4)
The Douleur Neuropathique 4 (DN4) questionnaire is a validated clinician-administered screening tool for neuropathic pain. It ranges from 0 to 10; higher values means higher neuropathic pain probability.
Time frame: 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)
The Numerical Rating Scale for Pain(NRS) is a tool used to assess pain intensity. It is a subjective measure in which individuals rate their pain on an eleven-point numerical scale, from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session
Modified Barthel Index (mBI)
The modified Barthel Index for Activities of Daily Living is a validated ordinal scale which measures a person's ability to complete activities of daily living (ADL). Scores range from 0 (total dependence) to 100 (total independence).
Time frame: Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session
Frenchay Arm Test (FAT)
The Frenchay Arm Test (FAT) assesses motor skills during activities of daily living (ADL) in patients with upper extremity impairments due to neurological conditions, using five practical tasks. Each task is scored 0 (unable) or 1 (able), for a total score of 0-5. Higher scores indicate better arm and hand function.
Time frame: Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session
Action Research Arm Test (ARAT)
The Action Research Arm Test (ARAT) is a 19 item observational measure used to assess upper extremity performance (coordination, dexterity and functioning). The 19 items comprising the ARAT are scored using a 4 point ordinal scale. Scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance.
Time frame: Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session
Short-Form Health Survey (SF-36)
The Short-Form Health Survey (SF-36) is a questionnaire that assesses a person's health status. It includes 36 items across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional health, and mental health. Each domain is scored from 0 to 100, with higher scores indicating better health or functioning.
Time frame: Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment. It ranges from 0 (worst) to 30 (best).
Time frame: Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session
Symbol Digit Modalities Test (SDMT)
The Symbol Digit Modalities Test evaluates information processing speed. It consists of a simple task of replacing symbols with numbers. Using a reference key, the patient has 90 seconds to match a sequence of symbols with the correspondent numbers as rapidly as possible. Both written or oral administration can be used. For each correct answer, a point is assigned. The higher the score, the faster the information processing speed.
Time frame: Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session
Cost-effectiveness analysis of CO-AIDER software
A cost-effectiveness analysis of the CO-AIDER software will be carried out in terms of the added value of the solution, defined as the ratio between Delta\_Outcome (i.e., the difference in clinical outcomes obtained with and without the support of the CO-AIDER software) and Delta\_Cost (i.e., the difference in treatment costs with and without the support of the CO-AIDER software).
Time frame: Baseline; within 48 hours from the 15th session; within 48 hours from the 30th session
Therapist satisfaction (Technology Acceptance Model, TAM)
Assessment of therapist satisfaction and technology acceptance using the Technology Acceptance Model (TAM). The TAM is a questionnaire used with the primary aim of identifying the determinants involved in the acceptance of Robotic and Allied Technology. The questionnaire consists of 4 sections (perceived usefulness, ease of use, compatibility, intention to use); each question includes a 7-point Likert scale, from 1 (worst) to 7 (best). The scoring is calculated for each section and is given by the average of the responses in that section, ranging from 1 (worst) to 7 (best).
Time frame: Within 48 hours from the 30th session
Patient satisfaction (Technology Acceptance Model, TAM)
Assessment of patient satisfaction and technology acceptance using the Technology Acceptance Model (TAM). The TAM is a questionnaire used with the primary aim of identifying the determinants involved in the acceptance of Robotic and Allied Technology. The questionnaire consists of 4 sections (perceived usefulness, ease of use, compatibility, intention to use); each question includes a 7-point Likert scale, from 1 (worst) to 7 (best). The scoring is calculated for each section and is given by the average of the responses in that section, ranging from 1 (worst) to 7 (best).
Time frame: Within 48 hours from the 30th session
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