Developmental Language DisordersSmartSpeechNCT06633874
Smart Computing Models, Sensors, and Early Diagnostic Speech and Language Deficiencies Indicators in Child Communication
A study testing TD Playing the Serious Game APSOU and Non-TD Playing Serious Game in people with Developmental Language Disorders and Developmental Articulation Disorder, run by University of Ioannina at 1 site in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Language Disorders, Developmental Articulation Disorder, Speech Disorder
- What is being tested?
- TD Playing the Serious Game APSOU and Non-TD Playing Serious Game
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteGreece
- Study dates
- 29 Mar 2021to 25 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Typically developing preschoolers and school-aged children
- Children diagnosed with neurodevelopmental disorders
- Children should be native Greek speakers
Who cannot join
- Children with other medical conditions
- Children on medications that might affect the results of the study
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
Read the detailed description
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.
To address the questions of this study, data from typically developing children will be compared with data from non-typically developing children, analyzing whether the AI system can synthesize multiple data points across assessment domains to generate a comprehensive diagnostic profile.
Participants will be recruited through an open call distributed via private and public health and educational establishments across Greece. The recruitment process will focus on parents of typically and non-typically developing children aged 4 to 12. Parents will be invited to attend informational meetings where the objectives, procedures, and ethical guidelines of the study will be thoroughly explained.
During these sessions, parents will receive comprehensive information about the purpose of the study, including the specific role of the serious game developed in the study. The nature of the game, the expected involvement of their children, and the data collection methods will be discussed in detail to ensure transparency. Parents will be asked to provide informed written consent for their children to participate in full compliance with the General Data Protection Regulation and ethical considerations. These steps are essential to ensure that the rights and privacy of the participants will be protected throughout the study. Parents will also provide their child's developmental history in an online questionnaire embedded in the system.
The study will include typically developing preschool and school-aged children and non-typically developing children. It will not include children with other medical conditions or on medications that could potentially influence the results.
After an informative meeting and written consent from parents, participants will wear a smartwatch and engage in a serious game (designed and developed by the research team). Children will play the SG under the direct supervision of clinicians. This game will be designed to assess various developmental domains, including speech, language, psychomotor skills, cognitive function, psychoemotional behavior, and hearing abilities. The game will capture speech and language data through gameplay interactions alongside sensor data from the wearable device and the tablet camera (eye tracking and heart rate variability).
This game-based approach will naturally and engagingly collect diverse data points, ensuring a comprehensive evaluation of the child\'s speech and language abilities.
The system will form its datasets for analysis to detect speech and language development, feeding data into the selected artificial intelligence algorithms. The study will measure communication, psychomotor, cognitive, and psychoemotional skills through designed activities. The responses during gameplay will be evaluated, creating the developmental profile of the participant.
This structured and ethical recruitment process will ensure complete adherence to data protection and ethical standards while maintaining active engagement from both parents and children. By incorporating face-to-face supervision and real-time monitoring during gameplay, the study will guarantee the quality and integrity of the data collected for analysis.
The SG, paired with sensors from the smartwatch, will collect real-time data, including:
- Game responses
- Speech responses
- Gaze data from the tablet camera
- Heart Rate Variability (captured through the smartwatch)
This multi-modal data will be processed using neural network/machine learning algorithms to classify speech and language abilities across different developmental stages. The use of these advanced AI models will enable the system to:
- Identify patterns of speech/language deficiencies.
- Differentiate between typically and non-typically developed children.
- Create individualized diagnostic profiles for each participant.
Finally, an evaluation and verification of the intelligent system will be performed.
- Conditions
- Developmental Language Disorders, Developmental Articulation Disorder, Speech Disorder, Neurodevelopmental Disorder (Diagnosis)
- Being tested
- TD Playing the Serious Game APSOU, Non-TD Playing Serious Game
- Keywords
- screening, developmental speech and language disorders, speech disorder, language disorder, developmental disorder, developmental deficiencies, neurodevelopmental disorder, Early Diagnostic Speech and Language Deficiencies Indicators, Machine Learning, Neural Networks, Serious Game, Child Communication, neurodevelopmental screening
- Medical subject headings
- Language Development Disorders, Articulation Disorders, Speech Disorders, Neurodevelopmental Disorders, Disease, Language Disorders, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD Playing the Serious Game APSOUDiagnostic test
After parents participate in informative meetings, they proceed with written consent, SmartSpeech enrollment, and child developmental history. Then, the child may interact with the Serious Game. Typically developed (TD) children engage under the clinician's face-to-face supervision with the serious game APSOU, which assesses developmental domains, including speech, language, psychomotor, cognitive, psychoemotional, and hearing abilities. The average time for TD children to play the whole game is estimated to be 45 minutes.
Non-TD Playing Serious GameDiagnostic test
After parents participate in informative meetings, they proceed with written consent, SmartSpeech enrollment, and child developmental history. Then the child may interact with the serious game. Non-typically developed (non-TD) children engage under the clinician's face-to-face supervision with the serious game Apsou, which assesses developmental domains, including speech, language, psychomotor, cognitive, psychoemotional, and hearing abilities. The average time for non-TD children to play the whole game is estimated to be over an hour.
| Study group | Role | What they receive |
|---|---|---|
| Typically Developed Children PLAYING SERIOUS GAME | Experimental | The arm describes the data collection process to design an intelligent system that contributes to implementing new innovative tools to assist clinicians and/or other professionals in the complicated screening and diagnostic procedures for communication deficiencies in children.
The main objective of this arm is to feed data from collected responses of TD children to the backend of the SmartSpeech system. The data we collect are Game responses, Speech responses, Gaze data from the tablet camera, and Heart Rate Variability (captured through the smartwatch). The backend system will use the data for training, evaluating, and validating the intelligence system. Receives: Diagnostic Test: TD Playing the Serious Game APSOU |
| Non-Typically Developed Children PLAYING SERIOUS GAME | Active comparator | The arm describes the data collection process to design an intelligent system that contributes to implementing new innovative tools to assist clinicians and/or other professionals in the complicated screening and diagnostic procedures for communication deficiencies in children. The main objective of this arm is to feed data from collected responses of Non-TD children to the backend of the SmartSpeech system. The data we collect are Game responses, Speech responses, Gaze data from the tablet camera, and Heart Rate Variability (captured through the smartwatch). The backend system will use the data for training, evaluating, and validating the intelligence system. Receives: Diagnostic Test: Non-TD Playing Serious Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech and language for TD children
Score on Serious Game responses in Speech and language activities (0 - 100) by TD children
Measured: 10-20 minutes
Psychomotor for TD children
Score on Serious Game responses in Psychomotor activities (0 - 100) by TD children
Measured: 10-20 minutes
Cognitive for TD children
Score on Serious Game responses in Cognitive activities (0 - 100) by TD children
Measured: 10-20 minutes
Psychoemotional for TD children
Score on Serious Game responses in Psychoemotional activities (0 - 100) by TD children
Measured: 10-20 minutes
Hearing for TD children
Score on Serious Game responses in Hearing activities (0 - 100) by TD children
Measured: 10-20 minutes
Eye-tracking fixation duration for TD children
Fixation Duration is the time the gaze stays on a single point in milliseconds (during specific activities in the Serious Game)
Measured: 1-10 minutes
Eye-tracking trajectory path for TD children
Trajectory Path is the overall movement path of the gaze in millimeters on screen (during specific activities in the Serious Game)
Measured: 1-10 minutes
Heart rate variability for TD children
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
Measured: 1-10 minutes
Speech and language for non-TD children
Score on Serious Game responses in Speech and language activities (0 - 100) by non-TD children
Measured: 10-20 minutes
Psychomotor for non-TD children
Score on Serious Game responses in Psychomotor activities (0 - 100) by non-TD children
Measured: 10-20 minutes
Cognitive for non-TD children
Score on Serious Game responses in Cognitive activities (0 - 100) by non-TD children
Measured: 10-20 minutes
Psychoemotional for non-TD children
Score on Serious Game responses in Psychoemotional activities (0 - 100) by non-TD children
Measured: 10-20 minutes
Hearing for non-TD children
Score on Serious Game responses in Hearing activities (0 - 100) by non-TD children
Measured: 10-20 minutes
Eye-tracking fixation duration for non-TD children
Fixation Duration is the time the gaze stays on a single point in milliseconds (during specific activities in the Serious Game)
Measured: 1-10 minutes
Eye-tracking trajectory path for non-TD children
Trajectory Path is the overall movement path of the gaze in millimeters on screen (during specific activities in the Serious Game)
Measured: 1-10 minutes
Heart rate variability for non-TD children
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
Measured: 1-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start29 Mar 2021
- Primary completion30 Jun 2023
- Study completion25 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Developmental Language DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Collaborators
- DOTSOFT SA - GR, TELEGLOBAL LP - GR, Region of Epirus (Regional Operational Programme 'Epirus 2014-2020') - GR, University Hospital, Ioannina
- Responsible party
- Principal investigator, Eugenia I Toki, University of Ioannina
- Investigators
- Eugenia I Toki, PhD, Study chair, University of Ioannina, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633874
- Sponsor's protocol ID
- HP1AB-28185 (MIS: 5033088)
- Other IDs
- 18435/15.05.2020
- Acronym
- SmartSpeech
- Status last verified
- Oct 2024
- First submitted
- 26 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The participants of this study did not give written consent for their data to be shared publicly, so due to privacy restrictions and the sensitive nature of this research data sharing is not applicable
Publications
Toki EI, Zakopoulou V, Tatsis G, Pange J. Automated Detection of Neurodevelopmental Disorders Using Face-to-Face Mobile Technology Among Typically Developing Greek Children: Randomized Controlled Trial. JMIR Form Res. 2024 Oct 11;8:e53465. doi: 10.2196/53465.
PubMed 39393054
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Computing Models, Sensors, and Early Diagnostic Speech and Language Deficiencies Indicators in Child Communication
- ClinicalTrials.gov ID
- NCT06633874
- Acronym / sponsor ID
- SmartSpeech / HP1AB-28185 (MIS: 5033088)
- Conditions
- Developmental Language Disorders, Developmental Articulation Disorder, Speech Disorder, Neurodevelopmental Disorder (Diagnosis)
- Keywords
- screening, developmental speech and language disorders, speech disorder, language disorder, developmental disorder, developmental deficiencies, neurodevelopmental disorder, Early Diagnostic Speech and Language Deficiencies Indicators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Collaborators
- DOTSOFT SA - GR, TELEGLOBAL LP - GR, Region of Epirus (Regional Operational Programme 'Epirus 2014-2020') - GR, University Hospital, Ioannina
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 25 Nov 2023 (actual)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
To address the questions of this study, data from typically developing children will be compared with data from non-typically developing children, analyzing whether the AI system can synthesize multiple data points across assessment domains to generate a comprehensive diagnostic profile.
Participants will be recruited through an open call distributed via private and public health and educational establishments across Greece. The recruitment process will focus on parents of typically and non-typically developing children aged 4 to 12. Parents will be invited to attend informational meetings where the objectives, procedures, and ethical guidelines of the study will be thoroughly explained.
During these sessions, parents will receive comprehensive information about the purpose of the study, including the specific role of the serious game developed in the study. The nature of the game, the expected involvement of their children, and the data collection methods will be discussed in detail to ensure transparency. Parents will be asked to provide informed written consent for their children to participate in full compliance with the General Data Protection Regulation and ethical considerations. These steps are essential to ensure that the rights and privacy of the participants will be protected throughout the study. Parents will also provide their child's developmental history in an online questionnaire embedded in the system.
The study will include typically developing preschool and school-aged children and non-typically developing children. It will not include children with other medical conditions or on medications that could potentially influence the results.
After an informative meeting and written consent from parents, participants will wear a smartwatch and engage in a serious game (designed and developed by the research team). Children will play the SG under the direct supervision of clinicians. This game will be designed to assess various developmental domains, including speech, language, psychomotor skills, cognitive function, psychoemotional behavior, and hearing abilities. The game will capture speech and language data through gameplay interactions alongside sensor data from the wearable device and the tablet camera (eye tracking and heart rate variability).
This game-based approach will naturally and engagingly collect diverse data points, ensuring a comprehensive evaluation of the child\'s speech and language abilities.
The system will form its datasets for analysis to detect speech and language development, feeding data into the selected artificial intelligence algorithms. The study will measure communication, psychomotor, cognitive, and psychoemotional skills through designed activities. The responses during gameplay will be evaluated, creating the developmental profile of the participant.
This structured and ethical recruitment process will ensure complete adherence to data protection and ethical standards while maintaining active engagement from both parents and children. By incorporating face-to-face supervision and real-time monitoring during gameplay, the study will guarantee the quality and integrity of the data collected for analysis.
The SG, paired with sensors from the smartwatch, will collect real-time data, including:
- Game responses
- Speech responses
- Gaze data from the tablet camera
- Heart Rate Variability (captured through the smartwatch)
This multi-modal data will be processed using neural network/machine learning algorithms to classify speech and language abilities across different developmental stages. The use of these advanced AI models will enable the system to:
- Identify patterns of speech/language deficiencies.
- Differentiate between typically and non-typically developed children.
- Create individualized diagnostic profiles for each participant.
Finally, an evaluation and verification of the intelligent system will be performed.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Typically Developed Children PLAYING SERIOUS GAME | Experimental | Diagnostic Test: TD Playing the Serious Game APSOUThe arm describes the data collection process to design an intelligent system that contributes to implementing new innovative tools to assist clinicians and/or other professionals in the complicated screening and diagnostic procedures for communication deficiencies in children. The main objective of this arm is to feed data from collected responses of TD children to the backend of the SmartSpeech system. The data we collect are Game responses, Speech responses, Gaze data from the tablet camera, and Heart Rate Variability (captured through the smartwatch). The backend system will use the data for training, evaluating, and validating the intelligence system. |
| Non-Typically Developed Children PLAYING SERIOUS GAME | Active comparator | Diagnostic Test: Non-TD Playing Serious GameThe arm describes the data collection process to design an intelligent system that contributes to implementing new innovative tools to assist clinicians and/or other professionals in the complicated screening and diagnostic procedures for communication deficiencies in children. The main objective of this arm is to feed data from collected responses of Non-TD children to the backend of the SmartSpeech system. The data we collect are Game responses, Speech responses, Gaze data from the tablet camera, and Heart Rate Variability (captured through the smartwatch). The backend system will use the data for training, evaluating, and validating the intelligence system. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Typically developing preschoolers and school-aged children
- Children diagnosed with neurodevelopmental disorders
- Children should be native Greek speakers
Key exclusion criteria (2 listed)
- Children with other medical conditions
- Children on medications that might affect the results of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TD Playing the Serious Game APSOUAfter parents participate in informative meetings, they proceed with written consent, SmartSpeech enrollment, and child developmental history. Then, the child may interact with the Serious Game. Typically developed (TD) children engage under the clinician's face-to-face supervision with the serious game APSOU, which assesses developmental domains, including speech, language, psychomotor, cognitive, psychoemotional, and hearing abilities. The average time for TD children to play the whole game is estimated to be 45 minutes. | Diagnostic test | Typically Developed Children PLAYING SERIOUS GAME |
| Non-TD Playing Serious GameAfter parents participate in informative meetings, they proceed with written consent, SmartSpeech enrollment, and child developmental history. Then the child may interact with the serious game. Non-typically developed (non-TD) children engage under the clinician's face-to-face supervision with the serious game Apsou, which assesses developmental domains, including speech, language, psychomotor, cognitive, psychoemotional, and hearing abilities. The average time for non-TD children to play the whole game is estimated to be over an hour. | Diagnostic test | Non-Typically Developed Children PLAYING SERIOUS GAME |
Primary outcome
Speech and language for TD children
Time frame: 10-20 minutes
Score on Serious Game responses in Speech and language activities (0 - 100) by TD children
Psychomotor for TD children
Time frame: 10-20 minutes
Score on Serious Game responses in Psychomotor activities (0 - 100) by TD children
Cognitive for TD children
Time frame: 10-20 minutes
Score on Serious Game responses in Cognitive activities (0 - 100) by TD children
Psychoemotional for TD children
Time frame: 10-20 minutes
Score on Serious Game responses in Psychoemotional activities (0 - 100) by TD children
Hearing for TD children
Time frame: 10-20 minutes
Score on Serious Game responses in Hearing activities (0 - 100) by TD children
Eye-tracking fixation duration for TD children
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 10-20 minutes
Score on Serious Game responses in Speech and language activities (0 - 100) by non-TD children
Psychomotor for non-TD children
Time frame: 10-20 minutes
Score on Serious Game responses in Psychomotor activities (0 - 100) by non-TD children
Cognitive for non-TD children
Time frame: 10-20 minutes
Score on Serious Game responses in Cognitive activities (0 - 100) by non-TD children
Psychoemotional for non-TD children
Time frame: 10-20 minutes
Score on Serious Game responses in Psychoemotional activities (0 - 100) by non-TD children
Hearing for non-TD children
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 39393054Toki EI, Zakopoulou V, Tatsis G, Pange J. Automated Detection of Neurodevelopmental Disorders Using Face-to-Face Mobile Technology Among Typically Developing Greek Children: Randomized Controlled Trial. JMIR Form Res. 2024 Oct 11;8:e53465. doi: 10.2196/53465.
- Individual participant dataSharing planned: No. The participants of this study did not give written consent for their data to be shared publicly, so due to privacy restrictions and the sensitive nature of this research data sharing is not applicable
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugenia I Toki, PhD study chair
University of Ioannina, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TD Playing the Serious Game APSOU and Non-TD Playing Serious Game in people with Developmental Language Disorders and Developmental Articulation Disorder, run by University of Ioannina at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech and language for TD children (time frame: 10-20 minutes). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06633874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.