An Investigation Into the Oral-motor and Speech Functions of Post-stroke Individuals Via an AI-powered Mobile Health Application
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Diadochokinetic (DDK) rate of alternating and sequential labial, alveolar and velar plosive sounds
研究概览
简要总结
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:
- To establish an image database of oral-facial movements of neurologically healthy adults and adult stroke patients in Hong Kong.
- To evaluate the oral-motor functions of neurologically healthy adults and stroke patients via instrumental and behavioral assessment.
- To investigate the correlation between image-based analysis of oral-facial functions and instrumental evaluations and subjective judgment by the speech-language therapist.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •participants who are unable to sign the "Informed Consent Form" due to cognitive impairments
- •For stroke patients,
- •Inclusion Criteria:
- •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.
- •Exclusion Criteria:
- •individuals currently on non-oral feeding; and
- •participants who are unable to sign the "Informed Consent Form" due to cognitive impairments
结局指标
主要结局
Diadochokinetic (DDK) rate of alternating and sequential labial, alveolar and velar plosive sounds
时间窗: 2-hr assessment
Participants will be asked to produce /pa/, /ta/, and /ka/ as quick as possible in 10 seconds as alternating motion rate and /pataka/ in 10 seconds as sequential motion rate.
Tongue strength endurance measured by tongue pressure sensor (model: TPM-02, JMS, Hiroshima, Japan)
时间窗: 2-hr assessment
Tongue endurance is defined as the time it takes to reach 60 % or more of maximum tongue strength. Three trials were performed, while the average duration (in terms of seconds) taken by the tongue pressure sensor will be used to determine tongue function.
Mastication efficiency as measured via glucose sensor (model: GS-II, GC Corporation, Toyko, Japan)
时间窗: 2-hr assessment
A 2-gram gummy jelly that comes with the glucose sensor will be put into the mouth, and the subject will be asked to chew the gummy for 20 seconds. Afterward, everything will be discharged into a paper cup, and the resultant filtrate will be examined quantitatively via the glucose sensor. Mastication efficiency will be illustrated in terms of milliliter per deciliter (mL/dL).
Occlusal force as measured via the occulsal pressure measurement film (model: Dental Prescale II, GC Corporation, Toyko, Japan)
时间窗: 2-hr assessment
An occlusal pressure measurement film will be put into the oral cavity and s/he will be asked to close the jaw firmly for 2-3 seconds. The film will be scanned by a scanner (model: GT-X830, Epson, Nagano, Japan) and analyzed by a software called Bite force analyzer manufactured by the GC Corporation. Occlusal force will be represented in Newton.
Maximum tongue strength measured by tongue pressure sensor (model: TPM-02, JMS, Hiroshima, Japan)
时间窗: 2-hr assessment
Participants will be asked to press the bulb of the tongue pressure sensor with the anterior part of the tongue as hard as they can. The maximum tongue strength in kilopascal (KPa) will be measured by the sensor.
次要结局
- The Chinese version of the Oral Health Impact Profile-14 (OHIP-14) questionnaire to assess oral health-related quality of life.(2-hr assessment)
- Chinese version of Eating Assessment Tool (EAT-10) questionnaire as a self-reported outcome instrument on swallowing functions(2-hr assessment)