AI-based Model for Rehabilitation Engagement and Motor Performance Evaluation in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Pediatric Rehabilitation Intervention Measure of Engagement - Observation (PRIME-O)
研究概览
简要总结
What is the purpose of this study? This study wants to learn how the physiological signals and movement data can help researchers understand and predict how children with neuromotor impairments engage with rehabilitation.
Who can take part? 40 participants between 5 and 17 years old will take part. Half of them will be children with neurotypical development (control). The other half will be children with neuromotor impairments.
What will happen in the study? Children within the control group will take part in 1 rehabilitation session, while those with neuromotor impairments will take part in 2 to 3 rehabilitation sessions as part of the treatment plan already provided by their referring physicians.
During each session, researchers will collect: (i) physiological signals like heart activity (ECG), heart rate variability (HRV), and electrodermal activity (EDA); (ii) movement data; (iii) exergames scores and motor performance data; (iv) questionnaires filled out by therapists to understand how engaged the participant is.
Children will use one of two technology-assisted rehabilitation systems during their sessions: either the Lokomat (robotic exoskeleton that supports children with impairments in walking) or the GRAIL system (a treadmill system with motion tracking and extended reality).
Why is this study important? Researchers will use the data to understand and predict how each child responds to therapy and engage with it. These analyses will help therapists adjust rehabilitation settings in real-time, offering more personalized and effective care for children with neuromotor impairments.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged between 5 and 17 with typical development.
- •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.
排除标准
- •Uncooperative subjects.
研究组 & 干预措施
Neuromotor impaired
干预措施: Inapplicable (Other)
Control
干预措施: Inapplicable (Other)
结局指标
主要结局
Pediatric Rehabilitation Intervention Measure of Engagement - Observation (PRIME-O)
时间窗: Baseline
This validated self-reported questionnaire is intended to capture observable indicators of patient and therapist engagement in therapy sessions. It is composed of 10 items, divided into 3 sections. Section A (4 items) groups items exclusively related to the patient engagement evaluation, Section B (4 items) lists items exclusively devoted to therapists, Section C (2 items) contains items that evaluate the interaction between patient and therapist. Each item is proposed on a 5-points Likert scale, with minimum value 0 and maximum value 4. Higher values stand for higher engagement levels.
次要结局
- Service Provider-Rated Measure of Client Engagement (PRIME-SP)(Baseline)
- Self-Assessment Manikin (SAM)(Baseline)
- Positive Affect and Negative Affect Scale (PANAS)(Baseline)
- Heart Rate (HR)(Baseline)
- Root Mean Square of Successive Differences (RMSSD)(Baseline)
- Low Frequency power of Heart Rate Variability (HRV LF)(Baseline)
- High Frequency power of Heart Rate Variability (HRV HF)(Baseline)
- Average Skin Conductance Level (AvSCL)(Baseline)
- Non-Specific Skin Conductance Responses (NSSCR)(Baseline)
- Low Frequency power of Skin Conductance Response (SCR LF)(Baseline)
- Walk Cadence(Baseline)
- Step Time(Baseline)
- Exergame score(Baseline)