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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Oral Motor Functions
• Intervention / Treatment: Diagnostic test: Speech and swallowing assessment

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Winsy Wing Sze Wong, PhD; Phone Number: 852-3400-3117; Email: winsyws.wong@polyu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 852
    • Recruiting
    • Speech Therapy Unit, Room 701, Block EF, The Hong Kong Polytechnic Unviersity
    • Contact: Janet Ng, Doctorate; Phone Number: 852-27667432; Email: janet-hy.ng@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Medically stable stroke patients and neurologically health adults aged between 20-85 years will be recruited.

Description

For Neurologically healthy adults,

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stroke patients; Adult stroke patients will be recruited to undergo a series of examinations on oral-motor and speech functions.	Diagnostic test: 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.
Control group; Neurologically healthy adults residing in Hong Kong will undergo the same set of assessments and procedures as the stroke patient group.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: The University of Hong Kong
• Investigators: Principal Investigator: Winsy Wing Sze Wong, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; artificial intelligence; Mobile App; speech; Oral Motor functions
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: P0046834; FBL/036/23 (Other Grant/Funding Number: Innovation and Technology Commission)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The dataset will be available on an open-access repository such as OSF.
• IPD Sharing Time Frame: 5 years upon the project end date
• IPD Sharing Access Criteria: Open access to all people
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No