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

Browse trials for

• Stroke 7,441
• Speech 76

Keywords

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

Stroke

7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's planned enrollment of 200 is above the median of 160 across 1,729 observational studies indexed under Stroke.

Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 676 studies on the registry; 254 are open to participants now.

Study population

Eligibility criteria

Groups and cohorts

• 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

• Diagnostic testSpeech 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 outcomes

1. 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.

   Time frame: 2-hr assessment

2. 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.

   Time frame: 2-hr assessment

3. 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).

   Time frame: 2-hr assessment

4. 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.

   Time frame: 2-hr assessment

5. 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.

   Time frame: 2-hr assessment

Secondary outcomes

1. 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.

   Time frame: 2-hr assessment

2. 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.

   Time frame: 2-hr assessment

Individual participant data

Plan to share: Yes — The dataset will be available on an open-access repository such as OSF.

Supporting information: Study protocol, Informed consent form

Time frame: 5 years upon the project end date

Access criteria: Open access to all people