Smart Computing Models, Sensors, and Early Diagnostic Speech and Language Deficiencies Indicators in Child Communication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 2
- 主要终点
- Speech and language for TD children
研究概览
简要总结
This clinical trial aims to justify a protocol for designing and developing an automated decision-making system to support and enhance screening and early detection procedures for developmental speech/language difficulties in child communication. The system will utilize smart computing models, sensors, and early diagnostic speech and language deficiency indicators. The study participants will be typically and non-typically (neurodevelopmentally atypical) developing children, primarily in preschool and elementary school.
The key research questions the study seeks to address are:
- Do differences exist between typically developing and neurodevelopmentally atypical children when engaging with the serious game used in the study?
- If such differences are identified, can the collected data be utilized to train an automated decision-making system capable of accurately distinguishing between typically and neurodevelopmentally atypical children based on speech and language deficiencies?
Researchers will compare typically and non-typically developed children to see if the system can incorporate multiple data points from assessment domains to create a diagnostic profile.
After the parents are informed of the study and provide written consent, they enroll in the system. Participants will be asked to wear a smartwatch and play a serious game on a tablet under the supervision of a clinician. The system will collect data from the gameplay and sensors.
详细描述
In recent years, integrating digital and mobile technologies in health and education has opened new possibilities for monitoring and assessment. This study will build on these advancements by implementing artificial intelligence (AI) and machine learning models that offer real-time decision-making and personalized feedback. By automating critical aspects of the diagnostic process, this system will help bridge the gap between traditional clinical expertise and cutting-edge technology, ultimately enhancing early intervention efforts.
The SmartSpeech study will be a clinical trial designed to create and validate an automated decision-making system to enhance the screening and early detection of developmental speech and language difficulties in young children. This study will target typically and non-typically (neurodevelopmentally atypical) developing children, primarily focusing on preschool and elementary school-aged participants. The system will employ intelligent computing models, biometric sensors, and early diagnostic indicators of speech and language deficiencies to provide clinicians with a robust tool for identifying potential developmental issues.
Two primary research questions drive the trial:
- Do differences exist between typically developing and neurodevelopmentally atypical children when engaging with the serious game used in the study?
- If such differences are identified, can the collected data be utilized to train an automated decision-making system that accurately distinguishes between typically and neurodevelopmentally atypical children based on speech and language deficiencies?
To assess speech and language developmental skills and their manifestations, the interdisciplinary team will design a serious game (SG) based on theories that measure speech and language and psychomotor, cognitive, psychoemotional, and hearing skills. Each domain will assess the performance of specific tasks within the SG activities for the participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Typically developing preschoolers and school-aged children
- •Children diagnosed with neurodevelopmental disorders
- •Children should be native Greek speakers
排除标准
- •Children with other medical conditions
- •Children on medications that might affect the results of the study
结局指标
主要结局
Speech and language for TD children
时间窗: 10-20 minutes
Score on Serious Game responses in Speech and language activities (0 - 100) by TD children
Psychomotor for TD children
时间窗: 10-20 minutes
Score on Serious Game responses in Psychomotor activities (0 - 100) by TD children
Cognitive for TD children
时间窗: 10-20 minutes
Score on Serious Game responses in Cognitive activities (0 - 100) by TD children
Psychoemotional for TD children
时间窗: 10-20 minutes
Score on Serious Game responses in Psychoemotional activities (0 - 100) by TD children
Hearing for TD children
时间窗: 10-20 minutes
Score on Serious Game responses in Hearing activities (0 - 100) by TD children
Eye-tracking fixation duration for TD children
时间窗: 1-10 minutes
Fixation Duration is the time the gaze stays on a single point in milliseconds (during specific activities in the Serious Game)
Eye-tracking trajectory path for TD children
时间窗: 1-10 minutes
Trajectory Path is the overall movement path of the gaze in millimeters on screen (during specific activities in the Serious Game)
Heart rate variability for TD children
时间窗: 1-10 minutes
Heart rate variability during the game that is calculated by HRV=(HRe-HRs)/HRs, HRs: Heart Rate at the start of the measurement, HRe: Heart Rate at the end of the measurement. The duration between start - end of each activity measurement is a few seconds
Speech and language for non-TD children
时间窗: 10-20 minutes
Score on Serious Game responses in Speech and language activities (0 - 100) by non-TD children
Psychomotor for non-TD children
时间窗: 10-20 minutes
Score on Serious Game responses in Psychomotor activities (0 - 100) by non-TD children
Cognitive for non-TD children
时间窗: 10-20 minutes
Score on Serious Game responses in Cognitive activities (0 - 100) by non-TD children
Psychoemotional for non-TD children
时间窗: 10-20 minutes
Score on Serious Game responses in Psychoemotional activities (0 - 100) by non-TD children
Hearing for non-TD children
时间窗: 10-20 minutes
Score on Serious Game responses in Hearing activities (0 - 100) by non-TD children
Eye-tracking fixation duration for non-TD children
时间窗: 1-10 minutes
Fixation Duration is the time the gaze stays on a single point in milliseconds (during specific activities in the Serious Game)
Eye-tracking trajectory path for non-TD children
时间窗: 1-10 minutes
Trajectory Path is the overall movement path of the gaze in millimeters on screen (during specific activities in the Serious Game)
Heart rate variability for non-TD children
时间窗: 1-10 minutes
Heart rate variability during the game that is calculated by HRV=(HRe-HRs)/HRs, HRs: Heart Rate at the start of the measurement, HRe: Heart Rate at the end of the measurement. The duration between start - end of each activity measurement is a few seconds
次要结局
未报告次要终点
研究者
Eugenia I Toki
Associate Professor, SmartSpeech Scientific Project Manager
University of Ioannina