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Use of an AI-powered Mobile Health App in Assessing and Training Oral Motor Functions (ORAR SG)

6 de noviembre de 2026 actualizado por: The Hong Kong Polytechnic University

This project aims to evaluate the usability of the ORAR app developed by HKPU and normed on the Hong Kong Chinese population, with the Singapore Malay and Chinese population.

It aims to:

  1. Establish normative data of the oromotor performance of neurologically healthy bilinguals of Malay ethnicity and/or Chinese ethnicity across a range of speech and non-speech tasks.
  2. Determine the factors (e.g., gender, age, education, type of stimuli, ethnicity) that influence oro-motor performance of Malay and Chinese adults respectively in Singapore.
  3. Collect feedback to evaluate the usability, acceptability and feasibility of the ORAR app from different users, namely the SLTs, persons with dysarthria and their caregivers.

Descripción general del estudio

Tipo de estudio

De observación

Inscripción (Estimado)

405

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.

Estudio Contacto

Ubicaciones de estudio

      • Hong Kong, Hong Kong
        • Aún no reclutando
        • The Hong Kong Polytechnic University, Hong Kong
        • Contacto:
      • Singapore, Singapur

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

21 años a 79 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

The study aims to recruit 150 Singaporean Malay bilinguals and 150 Singaporean Chinese bilinguals. These participants will comprise a range of ages (21-79 years old), with 25 participants from each decade age group.

Descripción

Inclusion Criteria for healthy adults:

  • (1) Adults aged 21-79 years who are Singapore citizens
  • (2) Absence of severe systemic conditions, including uncontrolled diabetes, cerebrovascular disease, head and neck tumours, or neurological disorders
  • (3) Not currently undergoing radiation therapy or chemotherapy
  • (4) Normal or corrected-to-normal vision and hearing
  • (5) Fluent in Malay/ English respectively
  • (6) No history of speech difficulties/disorders

Inclusion criteria for participants with dysarthria:

  • (1) Adults aged 21-79 years who are Singapore citizens
  • (2) Absence of severe systemic conditions, including uncontrolled diabetes, cerebrovascular disease, head and neck tumours, or neurological disorders
  • (3) Not currently undergoing radiation therapy or chemotherapy
  • (4) Normal or corrected-to-normal vision and hearing
  • (5) Fluent in Malay/ English respectively

Additional inclusion criteria for SLTs:

  • (1) AHPC licensed
  • (2) have been practising in Singapore for at least one year

Exclusion Criteria:

  • (1) individuals who are dependent on non-oral feeding
  • (2) individuals unable to provide informed consent due to cognitive impairment

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

  • Modelos observacionales: OTHER
  • Perspectivas temporales: PROSPECTIVE

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
healthy adults

For the normative study: 150 individuals of Malay descent (e.g., Boyanese, Javanese, Banjarese, Bugis, and Indonesian extract) and 150 bilingual Chinese individuals. Another 35 speech-language therapists and carers of dysarthric pateints will be recruited.

Inclusion criteria for healthy adults in the normative study, as well as SLTs and caregivers of individuals with dysarthria in the implementation study are as follows: (1) Adults aged 21-79 years who are Singapore citizens, (2)absence of severe systemic conditions, including uncontrolled diabetes, cerebrovascular disease, head and neck tumours, or neurological disorders, (3) not currently undergoing radiation therapy or chemotherapy, (4) normal or corrected-to-normal vision and hearing, (5) fluent in Malay/ English respectively, (6) no history of speech difficulties/disorders. Additional inclusion criteria for SLTs are: (1) AHPC licensed and (2) have been practising in Singapore for at least one year.

Dysarthria group

35 individuals with neurogenic dysarthria will be recruited. For the implementation study, inclusion criteria for participants with dysarthria include (1) to (5) above, with the exception of a history of stroke, and being diagnosed with an acquired speech sound disorder by an SLT. Exclusion criteria include (1) individuals who are dependent on non-oral feeding, (2) individuals unable to provide informed consent due to cognitive impairment. Written or digital consent will be obtained from all participants prior to participation.

Feasibility Study:

Participants wi l first complete a demographic form that collects information such as age, occupation, gender, housing type, and dental history.

This study will be conducted in a controlled environment, such as a quiet room at SIT, clinics, and participants' homes, under the guidance of SLT students. Participants wi l complete three 4-item measures of implementation outcomes - Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM; Weiner et al., 2017). Subsequently, they will be given 30 minutes to explore and experiment with the app's different features. Following this, participants will complete the AIM, IAM, and FIM again, as well as participate in a semi-structured interview with the SLT student on their experience using the app and feedback about the app. The app wil be available in Mandarin (Simplified) and English.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Range of movement of the articulators
Periodo de tiempo: 2-hr assessment

The range of movement of lips, tongue, and jaw of the participants will be analyzed by the computer vision model of ORAR to give range-of-motion scores.

2-hr assessment
Maximum phonation time
Periodo de tiempo: 2-hr assessment

Each participant will be asked to take a deep breathe and say 'ah' as long as they can. This will repeat for 3 times.

2-hr assessment
Diadochokinetic (DDK) rate
Periodo de tiempo: 2-hr assessment

The number of repeated syllables, trisyllabic non-word, trisyllabic Malay real word (only for Malay participants), trisyllabic English real word produced in 8 seconds will be measured.

2-hr assessment
Reading aloud a word list
Periodo de tiempo: 2-hr assessment

Participants will be asked to read aloud a word list covering phonetic inventory of the language and multisyllabic words (English: 38 words from Robertson Dysarthria Profile; Malay: 30 words selected from Malay Lexicon Project).

2-hr assessment
Personal narrative production
Periodo de tiempo: 2-hr assessment

Participants will be asked to recall a personal event.

2-hr assessment
Verbal fluency tasks
Periodo de tiempo: 2-hr assessment

Participants will be asked to produce as many items in a given category (e.g., fruits, vehicles) within a minute.

2-hr assessment
Acceptability, appropriateness and feasibility of ORAR
Periodo de tiempo: 2-hr assessment

A semi-structured interview will be conducted. Questions regarding the acceptability, apropriateness and feasibility of ORAR app will be asked.

2-hr assessment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Eating Assessment Tool (EAT-10) questionnaire as a self-reported outcome instrument on swallowing functions
Periodo de tiempo: 2-hr assessment

The questionnaire consists of 10 questions, and participants will be asked to evaluate their swallowing functions based on a 5-point Likert scale (0=not at all; 4=very much). Lower scores reflect better swallowing performance. Maximum and minimal scores are 40 and 0, respectively.

2-hr assessment
The Oral Health Impact Profile-14 (OHIP-14) questionnaire to assess oral health-related quality of life
Periodo de tiempo: 2-hr assessment

Participants will be asked to give ratings on the questionnaire based on a 5-point Likert scale. Lower scores represent better oral condition-related quality of life. The maximum and minimum scores are 56 and 0, respectively.

2-hr assessment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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)

1 de febrero de 2026

Finalización primaria (Estimado)

31 de agosto de 2028

Finalización del estudio (Estimado)

31 de agosto de 2028

Fechas de registro del estudio

Enviado por primera vez

6 de noviembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de noviembre de 2026

Publicado por primera vez (Actual)

12 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de noviembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

The IPD, together with the study protocol, will be shared in an open-access data repository (e.g., OSF).

Marco de tiempo para compartir IPD

Data will be shared starting from three months after manuscript publication.

Criterios de acceso compartido de IPD

The IPD and study protocol will be shared in an open-access data repository without restrictions.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • CIF

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. .

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