Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06635187
Acronym
ORAR
Enrollment
200
Registered
2024-10-10
Start date
2024-05-01
Completion date
2027-03-31
Last updated
2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Motor Functions, Stroke

Keywords

Mobile App, Stroke, Oral Motor functions, Rehabilitation, artificial intelligence, speech

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.

Interventions

DIAGNOSTIC_TESTSpeech 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.

Sponsors

The University of Hong Kong
CollaboratorOTHER
The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Tongue strength endurance measured by tongue pressure sensor (model: TPM-02, JMS, Hiroshima, Japan)2-hr assessmentTongue 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.
Occlusal force as measured via the occulsal pressure measurement film (model: Dental Prescale II, GC Corporation, Toyko, Japan)2-hr assessmentAn 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 assessmentParticipants 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.
Diadochokinetic (DDK) rate of alternating and sequential labial, alveolar and velar plosive sounds2-hr assessmentParticipants 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.
Mastication efficiency as measured via glucose sensor (model: GS-II, GC Corporation, Toyko, Japan)2-hr assessmentA 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).

Secondary

MeasureTime frameDescription
Chinese version of Eating Assessment Tool (EAT-10) questionnaire as a self-reported outcome instrument on swallowing functions2-hr assessmentThe 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.
The Chinese version of the Oral Health Impact Profile-14 (OHIP-14) questionnaire to assess oral health-related quality of life.2-hr assessmentParticipants 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.

Countries

Hong Kong

Contacts

Primary ContactWinsy Wing Sze Wong, PhD
winsyws.wong@polyu.edu.hk852-3400-3117

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026