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Recruiting NCT06635187

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

— Observational Stroke Oral Motor Functions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Speech and swallowing assessment.
Who it may be relevant to
Registry conditions: Stroke, Oral Motor Functions. Basic parameters: 20 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 test Speech 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.

Primary outcome measures

  • Diadochokinetic (DDK) rate of alternating and sequential labial, alveolar and velar plosive sounds [Time frame: 2-hr assessment]
  • Tongue strength endurance measured by tongue pressure sensor (model: TPM-02, JMS, Hiroshima, Japan) [Time frame: 2-hr assessment]
  • Mastication efficiency as measured via glucose sensor (model: GS-II, GC Corporation, Toyko, Japan) [Time frame: 2-hr assessment]
  • Occlusal force as measured via the occulsal pressure measurement film (model: Dental Prescale II, GC Corporation, Toyko, Japan) [Time frame: 2-hr assessment]
  • Maximum tongue strength measured by tongue pressure sensor (model: TPM-02, JMS, Hiroshima, Japan) [Time frame: 2-hr assessment]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

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

1\) 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Hong Kong · 1 center
  • Speech Therapy Unit, Room 701, Block EF, The Hong Kong Polytechnic Unviersity — Hong Kong

Identifiers

NCT: NCT06635187 · P0046834 · FBL/036/23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗