- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07625592
Co-design of an AI Rehabilitation Program for Children With Borderline Intellectual Disorder
28 de mayo de 2026 actualizado por: Jeong Yi Kwon, Samsung Medical Center
Multidisciplinary Experience-Based Collaborative Design (Co-design) Study of a Tablet-Based AI Cognitive and Language Rehabilitation Program for School-Aged Children With Borderline Intellectual Disorder
Co-design of an AI Rehabilitation Program for Children With Borderline Intellectual Disorder
Descripción general del estudio
Estado
Activo, no reclutando
Intervención / Tratamiento
Descripción detallada
This study aims to co-design a tablet-based artificial intelligence (AI) cognitive and language rehabilitation program for school-aged children with borderline intellectual disorder using an experience-based collaborative design (EBCD) approach.
Children with prior experience using the program, their legal guardians, and relevant professionals will participate in interviews and collaborative workshops to identify user needs and improve program usability.
Tipo de estudio
De observación
Inscripción (Estimado)
30
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Seoul
-
Seoul, Seoul, Corea del Sur, 06351
- Samsung Medical Center
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
The study population includes school-aged children with borderline intellectual disorder who have prior experience using a tablet-based AI cognitive and language rehabilitation program, their legal guardians, and professionals involved in the development or clinical application of rehabilitation programs for children with borderline intellectual disorder.
Descripción
Inclusion Criteria:
- School-aged children aged 7 to under 16 years with borderline intellectual disorder who have experienced the tablet-based AI cognitive and language rehabilitation program at least once
- Legal guardians of eligible children
- Developers of the AI rehabilitation program or professionals with expertise in cognition, language, learning, or rehabilitation for children with borderline intellectual disorder
Exclusion Criteria:
- Individuals who are unable to participate in interviews or workshops due to communication difficulties or inability to provide informed consent/assent
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Children With Borderline Intellectual Disorder
School-aged children aged 7 to under 16 years with borderline intellectual disorder who have experienced the tablet-based AI cognitive and language rehabilitation program at least once.
|
A tablet-based artificial intelligence (AI) cognitive and language rehabilitation program previously experienced by children with borderline intellectual disorder.
The study collects user and provider experiences through interviews and collaborative workshops to support experience-based co-design and program improvement.
|
|
Legal Guardians
Legal guardians of children with borderline intellectual disorder who have experienced the tablet-based AI cognitive and language rehabilitation program.
|
|
|
Developers and Professionals
Developers of the AI rehabilitation program and professionals with clinical expertise in cognition, language, learning, or rehabilitation for children with borderline intellectual disorder.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Qualitative Themes Regarding Participant Experiences with the AI Rehabilitation Program
Periodo de tiempo: Once per participant/professional during the interview or workshop session conducted post-intervention (overall data collection through December 2026).
|
Qualitative themes regarding participant experiences with the tablet-based AI cognitive and language rehabilitation program will be identified.
In-depth interviews will be conducted with users with borderline intellectual functioning and their legal guardians to explore usability and satisfaction.
Additionally, focus group discussions with developers and clinical professionals will be held to gather multidisciplinary insights.
All qualitative data will be analyzed using qualitative content analysis to extract key core themes.
Therefore, there is no quantitative scale used.
Results will be reported as identified thematic categories.
|
Once per participant/professional during the interview or workshop session conducted post-intervention (overall data collection through December 2026).
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Perceived Barriers and Challenges to AI Rehabilitation Program Use
Periodo de tiempo: Once per participant/professional during the interview or workshop session conducted post-intervention (overall data collection through December 2026).
|
Participant-perceived barriers and challenges related to the use of the tablet-based AI cognitive and language rehabilitation program will be identified.
Through semi-structured qualitative interviews with users with borderline intellectual functioning and their legal guardians, as well as focus group discussions with developers and clinical professionals, potential obstacles to program adherence, technical difficulties, and clinical limitations will be explored.
All qualitative data will be analyzed using thematic analysis to extract core barrier themes.
Therefore, there is no quantitative scale used.
Results will be reported as identified thematic categories.
|
Once per participant/professional during the interview or workshop session conducted post-intervention (overall data collection through December 2026).
|
|
Co-design Recommendations for AI Rehabilitation Program Improvement
Periodo de tiempo: Once per participant/professional during the co-design workshop sessions conducted during the study period (overall data collection through December 2026).
|
Recommendations for the improvement and optimization of the tablet-based AI cognitive and language rehabilitation program will be developed.
Through collaborative co-design workshops involving users with borderline intellectual functioning, their legal guardians, developers, and clinical professionals, actionable insights regarding feature enhancements and interface modifications will be explored.
All qualitative data gathered from the workshops will be analyzed using thematic analysis to synthesize core design recommendations.
Therefore, there is no quantitative scale used.
Results will be reported as identified thematic categories and recommendation frameworks.
|
Once per participant/professional during the co-design workshop sessions conducted during the study period (overall data collection through December 2026).
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
24 de abril de 2026
Finalización primaria (Estimado)
31 de diciembre de 2026
Finalización del estudio (Estimado)
31 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
12 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de mayo de 2026
Publicado por primera vez (Actual)
4 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025-12-062
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .