- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07931898
Use of an AI-powered Mobile Health App in Assessing and Training Oral Motor Functions (ORAR SG)
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:
- 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.
- 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.
- 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.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Victoria Lai, PHD
- Номер телефона: 65 65921189
- Электронная почта: victoria.lai@singaporetech.edu.sg
Места учебы
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Hong Kong, Гонконг
- Еще не набирают
- The Hong Kong Polytechnic University, Hong Kong
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Контакт:
- Winsy WS Wong, PHD
- Номер телефона: 852 34003117
- Электронная почта: winsyws.wong@polyu.edu.hk
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Singapore, Сингапур
- Рекрутинг
- Singapore Institute of Technology
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Контакт:
- Victoria Lai
- Номер телефона: 65 65921190
- Электронная почта: victoria.lai@singaporetech.edu.sg
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
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.
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: OTHER
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
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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. |
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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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Range of movement of the articulators
Временное ограничение: 2-hr assessment
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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
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Maximum phonation time
Временное ограничение: 2-hr assessment
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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
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Diadochokinetic (DDK) rate
Временное ограничение: 2-hr assessment
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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
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Reading aloud a word list
Временное ограничение: 2-hr assessment
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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
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Personal narrative production
Временное ограничение: 2-hr assessment
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Participants will be asked to recall a personal event. |
2-hr assessment
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Verbal fluency tasks
Временное ограничение: 2-hr assessment
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Participants will be asked to produce as many items in a given category (e.g., fruits, vehicles) within a minute. |
2-hr assessment
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Acceptability, appropriateness and feasibility of ORAR
Временное ограничение: 2-hr assessment
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A semi-structured interview will be conducted. Questions regarding the acceptability, apropriateness and feasibility of ORAR app will be asked. |
2-hr assessment
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Eating Assessment Tool (EAT-10) questionnaire as a self-reported outcome instrument on swallowing functions
Временное ограничение: 2-hr assessment
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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
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The Oral Health Impact Profile-14 (OHIP-14) questionnaire to assess oral health-related quality of life
Временное ограничение: 2-hr assessment
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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
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Соавторы и исследователи
Соавторы
Публикации и полезные ссылки
Общие публикации
- Azevedo, N., Kehayia, E., Jarema, G., Le Dorze, G., Beaujard, C., & Yvon, M. (2023). How artificial intelligence (AI) is used in aphasia rehabilitation: A scoping review. Aphasiology, 38(2), 305-336.
- Barbera DS, Huckvale M, Fleming V, Upton E, Coley-Fisher H, Doogan C, Shaw I, Latham W, Leff AP, Crinion J. NUVA: A Naming Utterance Verifier for Aphasia Treatment. Comput Speech Lang. 2021 Sep;69:None. doi: 10.1016/j.csl.2021.101221.
- Chen AW, Koh YT, Leong SW, Ng LW, Lee PS, Koh GC. Post community hospital discharge rehabilitation attendance: Self-perceived barriers and participation over time. Ann Acad Med Singap. 2014 Mar;43(3):136-44.
- Kim Y, Kim M, Kim J, Song TJ. Smartphone-Based Speech Therapy for Poststroke Dysarthria: Pilot Randomized Controlled Trial Evaluating Efficacy and Feasibility. J Med Internet Res. 2024 Apr 25;26:e56417. doi: 10.2196/56417.
- Macoir J, Lavoie M, Routhier S, Bier N. Key Factors for the Success of Self-Administered Treatments of Poststroke Aphasia Using Technologies. Telemed J E Health. 2019 Aug;25(8):663-670. doi: 10.1089/tmj.2018.0116. Epub 2018 Aug 24.
- Ng CS, Toh MP, Ng J, Ko Y. Direct medical cost of stroke in Singapore. Int J Stroke. 2015 Oct;10 Suppl A100:75-82. doi: 10.1111/ijs.12576. Epub 2015 Jul 14.
- Venketasubramanian N, Yin A, Lee LB, De Silva DA. Two decades of nation-wide community-based stroke support - The Singapore National Stroke Association. Int J Stroke. 2017 Apr;12(3):297-301. doi: 10.1177/1747493016676620. Epub 2016 Oct 24.
- Wang Z, Shi R, Moreira P. Post-stroke dysphagia: identifying the evidence missing. Front Med (Lausanne). 2025 Feb 26;12:1494645. doi: 10.3389/fmed.2025.1494645. eCollection 2025.
- Wong, W. S., Zhou, T. Y., Liu, Y., Tsang, H. T., Luk, C. L., Chan, T. H., Lam, W. Y. H., Wong, W. W. S., & Tsoi, J. K. H. (2023, June 21-24). Home-based app for oral muscle exercises (HOE): A preliminary study. Poster presented at the 2023 IADR/LAR General Session & Exhibition with WCPD (101st General Session & Exhibition of the IADR), Bogotá, Colombia.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Неврологические проявления
- Цереброваскулярные расстройства
- Заболевания головного мозга
- Заболевания центральной нервной системы
- Заболевания нервной системы
- Сосудистые заболевания
- Сердечно-сосудистые заболевания
- Нейроповеденческие проявления
- Коммуникативные расстройства
- Языковые расстройства
- Расстройства речи
- Расстройства артикуляции
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Инсульт
- Дизартрия
Другие идентификационные номера исследования
- 200917667D
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
The IPD, together with the study protocol, will be shared in an open-access data repository (e.g., OSF).
Сроки обмена IPD
Data will be shared starting from three months after manuscript publication.
Критерии совместного доступа к IPD
The IPD and study protocol will be shared in an open-access data repository without restrictions.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .