Efficacy of the Myofunctional Therapy on Oral Dysphagia

Primary outcomes

1. Change from Baseline in Pain at 10 weeks and 6 months

   Time frame: Baseline, 10 weeks, 6 months

   Visual Analog Scale will be used where patients will be asked to rate their pain on a scale from 0 to 10 with 0 indicating no pain and 10 the maximum worst pain, at the baseline and the end of 10 weeks intervention and at the end 6 months from baseline.

2. Change from Baseline in Tongue strength and endurance at 10 weeks and 6 months

   Time frame: Baseline, 10 weeks, 6 months

   Tongue strength will be assessed by Iowa Oral Performance Instrument with the measurement of muscle strength by tongue muscle pressure.

   Tongue endurance will be measured with the Iowa Oral Performance Instrument by quantifying the length of time that a patient may maintain 50% of his or her maximum pressure.

3. Change from Baseline in Jaw Function limitation at 10 weeks and 6 months

   Time frame: Baseline, 10 weeks, 6 months

   Jaw function limitation will be measured by the Jaw Functional Limitation Scale-20 (JFLS-20) where the patients will be asked from 1 to 10 points per item (higher scores indicate worse jaw function). The JFLS-20 has 3 subscales: Mastication (6 items), Vertical Jaw Mobility (4 items), and Emotional and Verbal Expression (10 items).

4. Change from Baseline in Swallowing dysfunction at 10 weeks and 6 months

   Time frame: Baseline, 10 weeks, 6 months

   The first evaluation for swallowing dysfunction will be assessed with 100 ml water swallow test (WST). For the WST, we will be ask participants to consume 100ml of water in the shortest amount of time. Patients will be assessed to have failed the WST according to published criteria of, (1) coughing or choking post swallow, (2) having a wet voice quality post swallow, or (3) being unable to drink the whole amount of water. Furthermore, the swallowing speed will be evaluated as the amount of consumed water divided by the elapsed time.

   The second evaluation for swallowing dysfunction will be assessed with Eating Assessment Tool-10 (EAT-10) questionnaire. The EAT-10 is a self-administered, symptom-specific outcome assessment for swallowing dysfunction, demonstrating good consistency, reproducibility, and validity. It consists of 10 questions answered in a scale of 0 to 4 (0: no problem to 4: severe problem), with the higher scores indicating severe dysphagic symptoms.

5. Change from Baseline in Quality of life at 10 weeks and 6 months

   Time frame: Baseline, 10 weeks, 6 months

   The quality of life will be evaluated with Swallowing-related Quality of Life questionnaire (Swal-QoL). The SWAL-QoL is a dysphagia specific quality of life instrument consisting of 44 items (11 scales) assessing ten QOL domains: food selection, burden, mental health, social functioning, fear, eating duration, eating desire, communication, sleep, and fatigue. Sleep and fatigue contribute to general QOL, whereas the other domains are contributors to dysphagia-specific QOL. The total SWAL-QOL score includes 23 items from seven domains.