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

Recruiting

• Conditions: Stroke; Oral Motor Functions
• Interventions: Diagnostic Test: Speech and swallowing assessment

• Registration Number: NCT06635187
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-27
• Study First Submitted QC: 2024-10-08
• Last Update Submitted: 2024-10-08
• Study First Posted: 2024-10-10
• Last Update Posted: 2024-10-10
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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

For stroke patients,

Inclusion Criteria:

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

Exclusion Criteria:

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stroke patients	Speech and swallowing assessment	Adult stroke patients will be recruited to undergo a series of examinations on oral-motor and speech functions.
Control group	Speech and swallowing assessment	Neurologically healthy adults residing in Hong Kong will undergo the same set of assessments and procedures as the stroke patient group.

Primary Outcome Measures

Name	Time	Method
Diadochokinetic (DDK) rate of alternating and sequential labial, alveolar and velar plosive sounds	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)	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)	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)	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)	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.

Secondary Outcome Measures

Name	Time	Method
The Chinese version of the Oral Health Impact Profile-14 (OHIP-14) questionnaire to assess oral health-related quality of life.	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.
Chinese version of Eating Assessment Tool (EAT-10) questionnaire as a self-reported outcome instrument on swallowing functions	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.

Trial Locations

Locations (1)

Speech Therapy Unit, Room 701, Block EF, The Hong Kong Polytechnic Unviersity; 🇭🇰 Hong Kong, Hong Kong