StrokeCOAIDERNCT07199322
Clinical validatiOn of an AI-based DEcision Support System for Robotic Upper Limb Rehabilitation in Patients With Stroke. A CO-AIDER Study.
A study testing Robotic upper limb rehabilitation in patients with Stroke with AI support and Robotic upper limb rehabilitation in patients with Stroke without AI support in people with Stroke and Stroke Ischemic, run by Fondazione Don Carlo Gnocchi ETS at 10 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Stroke Ischemic, Stroke Hemorrhagic
- What is being tested?
- Robotic upper limb rehabilitation in patients with Stroke with AI support and Robotic upper limb rehabilitation in patients with Stroke without AI support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesItaly
- Study dates
- Sep 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Italy10 sites
Fondazione Don Carlo Gnocchi, Centro Gala
Acerenza, PZ, 85011
Rocco Santarsiero
IRCSS Fondazione Don Carlo Gnocchi
Florence, FI, 50143
Francesca Cecchi
Fondazione Don Carlo Gnocchi, Santa Maria dei Poveri Polo Riabilitativo del Levante ligure
La Spezia, SP, 19125
Pietro Balbi
Scuola Superiore Sant'Anna
Pisa, PI, 56127
Antonio Frisoli
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, RM, 00128
Fabio Pilato
Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza
Roma, RM, 00166
Irene G Aprile, MD, PhD, +390633086500, iaprile@dongnocchi.it
Irene G Aprile
Fondazione Don Carlo Gnocchi, Centro Spalenza
Rovato, BS, 25038
Massimiliano Gobbo
Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
Sant'Angelo dei Lombardi, AV, 83054
Rita Mosca
Fondazione Don Carlo Gnocchi, Centro Santa Maria ai Colli - Presidio Sanitario Ausiliatrice
Torino, TO, 10133
Annalisa Coppo
Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
Tricarico, Mount, 75019
Marcello Magliulo
About this study
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:
Read more
- 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.
Read the 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
- Being tested
- Robotic upper limb rehabilitation in patients with Stroke with AI support, Robotic upper limb rehabilitation in patients with Stroke without AI support
- Keywords
- Stroke, Upper limb rehabilitation, Artificial Intelligence, Robot-assisted therapy, AI-supported robotic system, AI-based decision support system, rehabilitation
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic upper limb rehabilitation in patients with Stroke with AI supportDevice
Also called RT + COAIDER, Robotic Therapy + COAIDER
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 upper limb rehabilitation in patients with Stroke without AI supportDevice
Also called Robotic Therapy, RT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Robotic upper limb rehabilitation in patients with Stroke without AI support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Within 48 hours from the 30th session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Campus Bio-Medico, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Responsible party
- Sponsor
- Investigators
- Eugenio Guglielmelli, PhD, Study chair, Campus Bio-Medico UniversityIrene G Aprile, MD, PhD, Principal investigator, Fondazione Don Carlo Gnocchi ONLUS, Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199322
- Sponsor's protocol ID
- COAIDER
- Other IDs
- RF-2021-12375472
- Acronym
- COAIDER
- Status last verified
- Dec 2024
- First submitted
- 19 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30175845Germanotta 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.
PubMed 29769127Aprile 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.
PubMed 31834217
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical validatiOn of an AI-based DEcision Support System for Robotic Upper Limb Rehabilitation in Patients With Stroke. A CO-AIDER Study.
- ClinicalTrials.gov ID
- NCT07199322
- Acronym / sponsor ID
- COAIDER / COAIDER
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Campus Bio-Medico, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Robotic treatment with an AI-based decision support system (Robotic therapy + CO-AIDER software) | Experimental | Device: Robotic upper limb rehabilitation in patients with Stroke with AI supportParticipants 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. |
| Robotic treatment with parameters defined exclusively by the clinical team (Robotic Therapy) | Active comparator | Device: Robotic upper limb rehabilitation in patients with Stroke without AI supportParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic upper limb rehabilitation in patients with Stroke with AI supportAlso: RT + COAIDER, Robotic Therapy + COAIDERParticipants 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 treatment with an AI-based decision support system (Robotic therapy + CO-AIDER software) |
| Robotic upper limb rehabilitation in patients with Stroke without AI supportAlso: Robotic Therapy, RTParticipants 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. | Device | Robotic treatment with parameters defined exclusively by the clinical team (Robotic Therapy) |
Primary outcome
Usability and acceptability for therapists
Time frame: Baseline; during the study; within 48 hours from the end of the treatment
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.
Change from baseline in the Fugl-Meyer Assessment for the upper extremities - motor function (FMA-UE)
Time frame: Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session
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).
14 secondary outcomes
National Institutes of Health Stroke Scale (NIHSS)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
Time frame: Baseline; within 48 hours from the 15th session; within 48 hours from the 30th session
Therapist satisfaction (Technology Acceptance Model, TAM)
Time frame: Within 48 hours from the 30th session
Patient satisfaction (Technology Acceptance Model, TAM)
Time frame: Within 48 hours from the 30th session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Background: PubMed 30175845Mehrholz 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.
- Background: PubMed 29769127Germanotta 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.
- Background: PubMed 31834217Aprile 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eugenio Guglielmelli, PhD study chair
Campus Bio-Medico University
Irene G Aprile, MD, PhD principal investigator
Fondazione Don Carlo Gnocchi ONLUS, Roma
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic upper limb rehabilitation in patients with Stroke with AI support and Robotic upper limb rehabilitation in patients with Stroke without AI support in people with Stroke and Stroke Ischemic, run by Fondazione Don Carlo Gnocchi ETS at 10 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irene G Aprile, MD, PhD (+390633086500, iaprile@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability and acceptability for therapists (time frame: Baseline; during the study; within 48 hours from the end of the treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07199322, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.