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NCT Number: NCT06635187

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

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.

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Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Nervous System Diseases Oral Motor Functions Speech Vascular Diseases Verbal Behavior

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Hong Kong, 852

Location status: Recruiting

Location contact

Janet Ng, Doctorate

CONTACT

[email protected]

852-27667432

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

For Neurologically healthy adults,

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Speech and swallowing assessment

Diagnostic 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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

Secondary outcomes

  1. 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

    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. Chinese version of Eating Assessment Tool (EAT-10) questionnaire as a self-reported outcome instrument on swallowing functions

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Winsy Wing Sze Wong, PhD

CONTACT

[email protected]

852-3400-3117

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • The University of Hong Kong

Registry information

Official study title

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

Acronym: ORAR

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 10, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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