StrokeORARNCT06635187
ORal-motor Assessment and Rehabilitation Mobile App (ORAR App)
An observational study of Stroke and Oral Motor Functions, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Oral Motor Functions
- What is being tested?
- Speech and swallowing assessment
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2024to 31 Mar 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Medically stable stroke patients and neurologically health adults aged between 20-85 years will be recruited.
Who may be able to join
- 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
- age between 20 and 85 years old;
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- 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.
Who cannot join
- 1) participants who are unable to sign the "Informed Consent Form" due to cognitive impairments
- For stroke patients,
- individuals currently on non-oral feeding; and
- participants who are unable to sign the "Informed Consent Form" due to cognitive impairments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Speech Therapy Unit, Room 701, Block EF, The Hong Kong Polytechnic Unviersity
Hong Kong, Hong Kong, 852
Janet Ng, Doctorate, 852-27667432, janet-hy.ng@polyu.edu.hk
About this study
Official title: 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:
- 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.
- Conditions
- Stroke, Oral Motor Functions
- Being tested
- Speech and swallowing assessment
- Keywords
- Mobile App, Stroke, Oral Motor functions, Rehabilitation, artificial intelligence, speech
- Medical subject headings
- Stroke, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech and swallowing assessmentDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Adult stroke patients will be recruited to undergo a series of examinations on oral-motor and speech functions. Receives: Diagnostic Test: Speech and swallowing assessment | |
| Control group | Neurologically healthy adults residing in Hong Kong will undergo the same set of assessments and procedures as the stroke patient group. Receives: Diagnostic Test: Speech and swallowing assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 2-hr assessment
Secondary outcomes (2)
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.
Measured: 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.
Measured: 2-hr assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 May 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Winsy Wing Sze Wong, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635187
- Sponsor's protocol ID
- P0046834
- Other IDs
- FBL/036/23
- Acronym
- ORAR
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset will be available on an open-access repository such as OSF.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Oral-motor and Speech Functions of Post-stroke Individuals Via an AI-powered Mobile Health Application
- ClinicalTrials.gov ID
- NCT06635187
- Acronym / sponsor ID
- ORAR / P0046834
- Conditions
- Stroke, Oral Motor Functions
- Keywords
- Mobile App, Stroke, Oral Motor functions, Rehabilitation, artificial intelligence, speech
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The University of Hong Kong
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Diagnostic Test: Speech and swallowing assessmentAdult stroke patients will be recruited to undergo a series of examinations on oral-motor and speech functions. |
| Control group | – | Diagnostic Test: Speech and swallowing assessmentNeurologically healthy adults residing in Hong Kong will undergo the same set of assessments and procedures as the stroke patient group. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Medically stable stroke patients and neurologically health adults aged between 20-85 years will be recruited.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- 1) participants who are unable to sign the "Informed Consent Form" due to cognitive impairments
- For stroke patients,
- individuals currently on non-oral feeding; and
- participants who are unable to sign the "Informed Consent Form" due to cognitive impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech and swallowing assessmentThis 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. | Diagnostic test | Control group, Stroke patients |
Primary outcome
Diadochokinetic (DDK) rate of alternating and sequential labial, alveolar and velar plosive sounds
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
2 secondary outcomes
The Chinese version of the Oral Health Impact Profile-14 (OHIP-14) questionnaire to assess oral health-related quality of life.
Time frame: 2-hr assessment
Chinese version of Eating Assessment Tool (EAT-10) questionnaire as a self-reported outcome instrument on swallowing functions
Time frame: 2-hr assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Individual participant dataSharing planned: Yes. The dataset will be available on an open-access repository such as OSF.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Winsy Wing Sze Wong, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Oral Motor Functions, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Winsy Wing Sze Wong, PhD (852-3400-3117, winsyws.wong@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diadochokinetic (DDK) rate of alternating and sequential labial, alveolar and velar plosive sounds (time frame: 2-hr assessment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.