Clinical trial NCT06635187: ORal-motor Assessment and Rehabilitation Mobile App (ORAR App)
Official title: An Investigation Into the Oral-motor and Speech Functions of Post-stroke Individuals Via an AI-powered Mobile Health Application
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Oral Motor Functions
Keywords: Mobile App
Stroke
Oral Motor functions
Rehabilitation
artificial intelligence
speech
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
First posted: 2024-10-10
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medically stable stroke patients and neurologically health adults aged between 20-85 years will be recruited.

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.


Eligibility 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.

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

Primary outcomes:
measure: Diadochokinetic (DDK) rate of alternating and sequential labial, alveolar and velar plosive sounds
timeFrame: 2-hr assessment
measure: Tongue strength endurance measured by tongue pressure sensor (model: TPM-02, JMS, Hiroshima, Japan)
timeFrame: 2-hr assessment
measure: Mastication efficiency as measured via glucose sensor (model: GS-II, GC Corporation, Toyko, Japan)
timeFrame: 2-hr assessment
measure: Occlusal force as measured via the occulsal pressure measurement film (model: Dental Prescale II, GC Corporation, Toyko, Japan)
timeFrame: 2-hr assessment
measure: Maximum tongue strength measured by tongue pressure sensor (model: TPM-02, JMS, Hiroshima, Japan)
timeFrame: 2-hr assessment
Secondary outcomes:
measure: The Chinese version of the Oral Health Impact Profile-14 (OHIP-14) questionnaire to assess oral health-related quality of life.
timeFrame: 2-hr assessment
measure: Chinese version of Eating Assessment Tool (EAT-10) questionnaire as a self-reported outcome instrument on swallowing functions
timeFrame: 2-hr assessment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Speech Therapy Unit, Room 701, Block EF, The Hong Kong Polytechnic Unviersity
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Winsy Wing Sze Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References: