Clinical validatiOn of an AI-based DEcision Support System for Robotic Upper Limb Rehabilitation in Patients With Stroke. A CO-AIDER Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 19
- 主要终点
- Usability and acceptability for therapists
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Usability and acceptability for therapists
时间窗: 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)
时间窗: 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).
次要结局
- Symbol Digit Modalities Test (SDMT)(Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session)
- Montreal Cognitive Assessment (MoCA)(Baseline (within 7 days of enrollment); within 48 hours from the 15th session; within 48 hours from the 30th session)
- Frenchay Arm Test (FAT)(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)(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)(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)
- Modified Barthel Index (mBI)(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)(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(Baseline; within 48 hours from the 15th session; within 48 hours from the 30th session)
- Therapist satisfaction (Technology Acceptance Model, TAM)(Within 48 hours from the 30th session)
- Patient satisfaction (Technology Acceptance Model, TAM)(Within 48 hours from the 30th session)