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

NCT06635187 | Recruiting DMC

• 2 other identifiers: P0046834FBL/036/23
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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. 1.To establish an image database of oral-facial movements of neurologically healthy adults and adult stroke patients in Hong Kong.
2. 2.To evaluate the oral-motor functions of neurologically healthy adults and stroke patients via instrumental and behavioral assessment.
3. 3.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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• The Chinese version of the Oral Health Impact Profile-14 (OHIP-14) questionnaire to assess oral health-related quality of life.

  2-hr assessment

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

  2-hr assessment

Study Arms (2)

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

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

Interventions

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.

Control group; Stroke patients

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \) participants who are unable to sign the "Informed Consent Form" due to cognitive impairments
• For stroke patients,
• 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.
• individuals currently on non-oral feeding; and
• participants who are unable to sign the "Informed Consent Form" due to cognitive impairments

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• The University of Hong Kong: collaborator

Study Sites (1)

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

Hong Kong, Hong Kong, 852, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke; Speech

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Verbal Behavior; Communication; Behavior

Study Officials

• Winsy Wing Sze Wong, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Winsy Wing Sze Wong, PhD

CONTACT

852-3400-3117; winsyws.wong@polyu.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 10, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: October 10, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 5 years upon the project end date
• Access Criteria: Open access to all people

Locations

HK (1)