Integrating AI in Stroke Neurorehabilitation (AISN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 192
- 试验地点
- 4
- 主要终点
- Upper limb motor change
研究概览
简要总结
The AISN multicenter randomized controlled trial will assess the effectiveness of a novel artificial intelligence (AI)-based clinical decision-support system integrated into the Rehabilitation Gaming System (RGS) for home-based post-stroke rehabilitation. Approximately 192 participants ≥6 months post-stroke will be recruited across several European centers and assigned to one of three groups: RGS with AI decision support, RGS without AI, or standard care. The primary outcome is upper limb motor improvement for stroke patients, with secondary measures including cognitive function, independence, quality of life, usability, cost-effectiveness, and AI-based support performance.
详细描述
The AISN study addresses the gap in long-term, personalized stroke rehabilitation after hospital discharge by evaluating an enhanced digital therapy platform that combines the clinically validated Rehabilitation Gaming System (RGS) with a newly developed AI-based decision-support module. This AI component analyzes patient performance data to provide clinicians with diagnostic and prognostic insights, along with tailored exercise prescriptions.
The trial's key innovation is the formal validation of the AI module in real-world clinical settings, assessing its concordance with clinician decisions, predictive accuracy, and contribution to patient outcomes.
Participants will be randomized into three groups:
RGS+AI: Home-based RGS therapy with AI-driven recommendations for clinicians. RGS-AI: Home-based RGS therapy without AI support. Control: Standard rehabilitation care. The intervention phase will last 12 weeks, with daily home training for experimental groups, and follow-up at 20 weeks. In addition to standard clinical endpoints, the study will include predefined AI validation metrics, focusing on its potential as a certified medical device tool for scalable, personalized rehabilitation delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 6 months post-stroke
- •Patients presenting a first-ever ischemic or intracerebral hemorrhagic stroke
- •Mild to Moderate unilateral upper limb motor impairment: Medical Research Council proximal and distal upper limb MRC ≥2; Action Research Arm Test: ARAT score < 50 (0 = no function, 57 = no functional limitation).
- •Age > 18 years old
- •Able to sit on a chair or a wheelchair and interact with RGS during an entire session
- •Minimal experience with smartphone technology based on the clinician's opinion
- •Willing to participate in the RGS therapy
- •Sign the Informed Consent Form
排除标准
- •Diagnosis with Epilepsy
- •Severe cognitive capabilities preventing the execution of the experiment or according to clinicians' criteria.
- •Severe associated impairment such as proximal but not distal spasticity, communication disabilities (sensory, Wernicke aphasia or apraxia), major pain (VAS > 75-100 mm), orthopedic devices that would interfere with the correct execution of the experiment (Modified Ashworth Scale > 3)
- •Unable to use the RGS app independently according to the clinician's observations and lacking support from a caregiver to use the RGS app
- •No experience with smartphone technology or based on the clinician's opinion.
- •Refusal to sign the Informed Consent
- •Participating or planning to participate in another trial while being part of the present study.
研究组 & 干预措施
RGS with AI-based Clinical Decision Support
Participants receive home-based virtual reality rehabilitation using the Rehabilitation Gaming System (RGS@home), with exercise prescriptions personalized by an AI-driven clinical decision support system. Clinicians can review and adjust these prescriptions remotely.
干预措施: AI-personalized virtual reality rehabilitation system for unsupervised home-based stroke therapy (Device)
RGS without AI-based Decision Support
Participants receive the same home-based RGS virtual reality rehabilitation, but exercise prescriptions are set and adjusted manually by clinicians without AI assistance.
干预措施: AI-personalized virtual reality rehabilitation system for unsupervised home-based stroke therapy (Device)
Control Group - Standard Care
Participants receive usual post-stroke rehabilitation services available at their site, without access to the RGS@home platform.
结局指标
主要结局
Upper limb motor change
时间窗: From enrollment to the end of treatment at 12 weeks, and follow-up at 20 weeks
Evaluation with the ARAT scale
次要结局
- Therapists' qualitative evaluation of the AI-based decision support system performance(At the end of the study, at 20 weeks.)
- Cognitive function change(From enrollment to the end of treatment at 12 weeks, and follow-up at 20 weeks)
- Disability evaluation(From enrollment to the end of treatment at 12 weeks, and follow-up at 20 weeks)
- Emotional change(From enrollment to the end of treatment at 12 weeks, and follow-up at 20 weeks)
- Quality of life and Health status(From enrollment to the end of treatment at 12 weeks, and follow-up at 20 weeks)