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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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 person
• Устройство 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 person

Первичные конечные точки

• Usability and acceptability for therapists [Срок оценки: 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) [Срок оценки: Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session]

Вторичные конечные точки (12)

• National Institutes of Health Stroke Scale (NIHSS) [Срок оценки: Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session]
• Motricity Index (MI) [Срок оценки: Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session]
• Modified Ashworth Scale (MAS) [Срок оценки: Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session]
• Douleur Neuropathique 4 (DN4) [Срок оценки: 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) [Срок оценки: Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session]
• Modified Barthel Index (mBI) [Срок оценки: Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session]
• Frenchay Arm Test (FAT) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session]
• Montreal Cognitive Assessment (MoCA) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Baseline; within 48 hours from the 15th session; within 48 hours from the 30th session]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Италия · 10 центров

• Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo — Sant'Angelo dei Lombardi
• Fondazione Don Carlo Gnocchi, Centro Spalenza — Rovato
• IRCSS Fondazione Don Carlo Gnocchi — Florence
• Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo — Tricarico
• Scuola Superiore Sant'Anna — Pisa
• Fondazione Don Carlo Gnocchi, Centro Gala — Acerenza
• Fondazione Policlinico Universitario Campus Bio-Medico — Roma
• Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza — Roma
• … и ещё 2 центра

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT07199322 · COAIDER · RF-2021-12375472

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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