- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Victoria Lai, PHD
- Telefonní číslo: 65 65921189
- E-mail: victoria.lai@singaporetech.edu.sg
Studijní místa
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Hong Kong, Hongkong
- Zatím nenabíráme
- The Hong Kong Polytechnic University, Hong Kong
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Kontakt:
- Winsy WS Wong, PHD
- Telefonní číslo: 852 34003117
- E-mail: winsyws.wong@polyu.edu.hk
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Singapore, Singapur
- Nábor
- Singapore Institute of Technology
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Kontakt:
- Victoria Lai
- Telefonní číslo: 65 65921190
- E-mail: victoria.lai@singaporetech.edu.sg
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: OTHER
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Range of movement of the articulators
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Eating Assessment Tool (EAT-10) questionnaire as a self-reported outcome instrument on swallowing functions
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Neurologické projevy
- Cerebrovaskulární poruchy
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Cévní onemocnění
- Kardiovaskulární choroby
- Neurobehaviorální projevy
- Poruchy komunikace
- Poruchy jazyka
- Poruchy řeči
- Poruchy artikulace
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Mrtvice
- Dysartrie
Další identifikační čísla studie
- 200917667D
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
The IPD, together with the study protocol, will be shared in an open-access data repository (e.g., OSF).
Časový rámec sdílení IPD
Data will be shared starting from three months after manuscript publication.
Kritéria přístupu pro sdílení IPD
The IPD and study protocol will be shared in an open-access data repository without restrictions.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- ICF
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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