ORal-motor Assessment and Rehabilitation Mobile App (ORAR App)

Официальное название

An Investigation Into the Oral-motor and Speech Functions of Post-stroke Individuals Via an AI-powered Mobile Health Application

Обзор

The goal of this study is to set up a database of oral-motor and speech functions of post-stroke patients in Hong Kong via an artificial intelligence-powered mobile-health application. The main study objectives are: 1. To establish an image database of oral-facial movements of neurologically healthy adults and adult stroke patients in Hong Kong. 2. To evaluate the oral-motor functions of neurologically healthy adults and stroke patients via instrumental and behavioral assessment. 3. To investigate the correlation between image-based analysis of oral-facial functions and instrumental evaluations and subjective judgment by the speech-language therapist.

Вмешательства

• Диагностический тест Speech and swallowing assessment
  This is an observational study in which post-stroke patients will undergo a series of assessments tapping oral-motor and speech functions. Both behavioral and instrumental examinations will be used. Their performance will be captured via an artificial intelligence(AI)-powered mobile health application. The relation between the oral/speech-motor movements captured by the app and their performance as measured via instruments/behavioral means will be investigated.

Первичные конечные точки

• Diadochokinetic (DDK) rate of alternating and sequential labial, alveolar and velar plosive sounds [Срок оценки: 2-hr assessment]
• Tongue strength endurance measured by tongue pressure sensor (model: TPM-02, JMS, Hiroshima, Japan) [Срок оценки: 2-hr assessment]
• Mastication efficiency as measured via glucose sensor (model: GS-II, GC Corporation, Toyko, Japan) [Срок оценки: 2-hr assessment]
• Occlusal force as measured via the occulsal pressure measurement film (model: Dental Prescale II, GC Corporation, Toyko, Japan) [Срок оценки: 2-hr assessment]
• Maximum tongue strength measured by tongue pressure sensor (model: TPM-02, JMS, Hiroshima, Japan) [Срок оценки: 2-hr assessment]

Вторичные конечные точки (2)

• The Chinese version of the Oral Health Impact Profile-14 (OHIP-14) questionnaire to assess oral health-related quality of life. [Срок оценки: 2-hr assessment]
• Chinese version of Eating Assessment Tool (EAT-10) questionnaire as a self-reported outcome instrument on swallowing functions [Срок оценки: 2-hr assessment]

Критерии участия

For Neurologically healthy adults,

Критерии включения

• age between 20 and 85 years old;
• no severe systemic diseases such as uncontrolled diabetes, cerebrovascular diseases, head and neck tumors, or neurological disorders;
• not undergoing radiation therapy or chemotherapy;
• normal or corrected-to-normal vision and hearing; and
• fluent Cantonese speakers

Критерии исключения

1\) participants who are unable to sign the "Informed Consent Form" due to cognitive impairments

For stroke patients,

Критерии включения

• age between 20 and 85 years old;
• a history of stroke;
• not undergoing radiation therapy or chemotherapy;
• normal or corrected-to-normal vision and hearing;
• premorbid fluent Cantonese speakers; and
• able to follow simple commands.

Критерии исключения

• individuals currently on non-oral feeding; and
• participants who are unable to sign the "Informed Consent Form" due to cognitive impairments

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Гонконг · 1 центр

• Speech Therapy Unit, Room 701, Block EF, The Hong Kong Polytechnic Unviersity — Гонконг

Идентификаторы

NCT: NCT06635187 · P0046834 · FBL/036/23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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