AI-based Model for Rehabilitation Engagement and Motor Performance Evaluation in Pediatric Patients: A Pilot Study (AI-REMAP)
AI-based Model for Rehabilitation Engagement and Motor Performance Evaluation in Pediatric Patients
What is the purpose of this study? This study aims to evaluate the usability and feasibility of an artificial intelligence-based model designed to monitor in real-time the engagement and motor performance of pediatric patients during technology-assisted rehabilitation.
Who can take part? 15 participants between 5 and 17 years old with neuromotor impairments will take part, along with at least 5 of their referring physiotherapists.
What will happen in the study? Each pediatric patient will take part in a single, 1-hour rehabilitation session using either the Lokomat or GRAIL system, according to their standard clinical prescription. During the session, the physiotherapist will have access to a display showing real-time data from the AI model, including the patient's heart rate, engagement level, pleasantness, activation, and motor performance. At the end of the session, the physiotherapist will complete a System Usability Scale (SUS) questionnaire and provide direct feedback on how to improve the model.
Why is this study important? Assessing the usability of this real-time monitoring tool is a necessary step to understand if it is practical for clinical use. Providing therapists with objective, real-time insights into a child's psychological and physical state can ultimately help tailor therapy to the specific needs of each patient, improving the overall rehabilitation experience.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Simone Costantini, MSc
- 邮箱：simone.costantini@lanostrafamiglia.it
研究联系人备份
- 姓名：Fabio Alexander Storm, PhD
- 电话号码：+39 031877111
- 邮箱：fabio.storm@lanostrafamiglia.it
学习地点
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Bosisio Parini、意大利、23842
- Scientific Institute IRCCS E.Medea
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接触：
- Emilia Biffi, PhD
- 电话号码：+39 031877111
- 邮箱：emilia.biffi@lanostrafamiglia.it
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副研究员：
- Simone Costantini, MSc
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接触：
- Fabio Alexander Storm, PhD
- 电话号码：+39 031877111
- 邮箱：fabio.storm@lanostrafamiglia.it
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参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
Inclusion Criteria:
- Subjects aged between 5 and 17 years with neuromotor impairments who are undergoing rehabilitation therapy using the Lokomat and GRAIL devices, according to the existing clinical plan.
Exclusion Criteria:
- Uncooperative subjects.
学习计划
研究是如何设计的？
设计细节
- 主要用途：设备可行性
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Real-Time Engagement Monitoring
Participants in this experimental arm, consisting of pediatric patients with neuromotor impairments, will undergo a single 1-hour technology-assisted rehabilitation session using either the Lokomat or GRAIL system.
During the session, the physiotherapist will use a display showing real-time outputs from the AI-based model, including the patient's heart rate, engagement levels, pleasantness, activation, and motor performance.
The model acts as an observational support tool and will not directly alter the standard rehabilitation protocol.
At the end of the session, the physiotherapist will evaluate the usability of the system.
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The intervention consists of the deployment of a real-time AI-based monitoring system during a standard technology-assisted rehabilitation session.
The physiotherapist is provided with a display showing continuous feedback on the patient's engagement levels, emotional state (pleasantness and activation), motor performance, and heart rate.
The model processes physiological and inertial data collected via wearable sensors, acting purely as an observational support tool without altering the standard rehabilitation protocol.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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System Usability Scale (SUS) Score
大体时间：Baseline
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This validated questionnaire is intended to evaluate the usability and feasibility of a system or product.
It is composed of 10 items assessing factors such as system complexity, ease of use, and functionality integration.
Each item is proposed on a 5-points Likert scale, with minimum value 1 and maximum value 5. Higher overall values stand for a higher degree of agreement with respect to the statement provided by the single item.
For odd items, higher values stand for higher usability.
For even items, higher values stand for lower usability.
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Baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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服务提供商评级的客户参与度衡量标准（PRIME-SP）
大体时间：基线
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该措施旨在捕获治疗师对患者参与度的观察。
Prime SP是一项经过验证的自我报告的问卷，由三个主要部分组成：A部分，治疗师可以根据5点Likert量表（从0到4到4，较高的值对应于积极参与度）对患者参与进行总体评估； B部分，治疗师可以根据5点李克特量表（0到4，较高的值对应于正互动）对患者参与度进行域依赖性（情感，认知，行为领域）评估； C部分，治疗师可以免费记录他/她认为可能影响患者参与会议的因素和情况的情况。
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基线
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AI Model-Inferred Engagement Level
大体时间：Baseline
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This objective measure is intended to capture the patient's continuous engagement level during the rehabilitation session.
The AI-based model infers the engagement state using feed-forward neural networks that process real-time physiological data (such as HRV and EDA) and inertial signals (IMU).
The model provides a categorical evaluation of engagement (low vs high).
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Baseline
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合作者和调查者
出版物和有用的链接
一般刊物
- Costantini S, Falivene A, Chiappini M, Malerba G, Dei C, Bellazzecca S, Storm FA, Andreoni G, Ambrosini E, Biffi E. Artificial intelligence tools for engagement prediction in neuromotor disorder patients during rehabilitation. J Neuroeng Rehabil. 2024 Dec 19;21(1):215. doi: 10.1186/s12984-024-01519-2.
- Koenig A, Omlin X, Zimmerli L, Sapa M, Krewer C, Bolliger M, Muller F, Riener R. Psychological state estimation from physiological recordings during robot-assisted gait rehabilitation. J Rehabil Res Dev. 2011;48(4):367-85. doi: 10.1682/jrrd.2010.03.0044.
- Graffigna G, Barello S, Riva G, Castelnuovo G, Corbo M, Coppola L, Daverio G, Fauci A, Iannone P, Ricciardi W, Bosio AC; CCIPE Working Group. [Recommandation for patient engagement promotion in care and cure for chronic conditions.]. Recenti Prog Med. 2017 Nov;108(11):455-475. doi: 10.1701/2812.28441. Italian.
- Flynn R, Walton S, Scott SD. Engaging children and families in pediatric Health Research: a scoping review. Res Involv Engagem. 2019 Nov 4;5:32. doi: 10.1186/s40900-019-0168-9. eCollection 2019.
- Bray L, Appleton V, Sharpe A. The information needs of children having clinical procedures in hospital: Will it hurt? Will I feel scared? What can I do to stay calm? Child Care Health Dev. 2019 Sep;45(5):737-743. doi: 10.1111/cch.12692. Epub 2019 Jul 18.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- L2-246-F2
- RC 2024-2026 to E. Biffi (其他赠款/资助编号：Italian Ministry of Health)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
IPD 共享支持信息类型
- 研究方案
- 树液
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