Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Functional Oral Intake Scale (FOIS) |
FOIS is a scale used for purposes to assess changes in functional oral intake of food and liquids in patients with dysphagia. FOIS is sensitive to changes in oral intake of food and liquid over time in stroke patients. The scale ranges from level 1 (nothing by mouth) to level 7 (a full unrestricted oral diet) |
Baseline, At 4 weeks from baseline |
|
| Primary |
Penetration-aspiration Scale (PAS) |
PAS is a standard scale to assess deglutition in clinical practice and research. It is composed of an 8-point scale used to characterize both the location of airway invasion events and patient's response during video fluoroscopic swallowing studies. The scale design to capture three constructs: depth of airway invasion, material remaining after swallow, and patient's response to aspiration. The scale ranges from score 1 (Material does not enter the airway) to score 8 (Material enters the airway, passes below the level of the vocal folds, and no effort is made to eject) |
Baseline, At 4 weeks from baseline |
|
| Secondary |
Functional Oral Intake Scale (FOIS) |
FOIS is a scale used for purposes to assess changes in functional oral intake of food and liquids in patients with dysphagia. FOIS is sensitive to changes in oral intake of food and liquid over time in stroke patients. The scale ranges from level 1 (nothing by mouth) to level 7 (a full unrestricted oral diet) |
Baseline, At 2, 4, and 8 weeks from baseline |
|
| Secondary |
Penetration-aspiration Scale (PAS) |
PAS is a standard scale to assess deglutition in clinical practice and research. It is composed of an 8-point scale used to characterize both the location of airway invasion events and patient's response during video fluoroscopic swallowing studies. The scale design to capture three constructs: depth of airway invasion, material remaining after swallow, and patient's response to aspiration. The scale ranges from score 1 (Material does not enter the airway) to score 8 (Material enters the airway, passes below the level of the vocal folds, and no effort is made to eject) |
Baseline, At 2, 4, and 8 weeks from baseline |
|
| Secondary |
Videofluoroscopic Dysphagia Scale (VDS) |
The scale contains 14 categories that represent both oral functions (lip, closure, mastication , bolus formation, premature bolus loss, apraxia and oral transit time) and pharyngeal functions (pharyngeal triggering, laryngeal elevation, epiglottic closure, pharyngeal transit time, pharyngeal coating, vallecular and pyriform sinus residues, and tracheal aspiration), with a sum of 100 points. |
Baseline, At 2, 4, and 8 weeks from baseline |
|
| Secondary |
Korean Mann Assessment of Swallowing Ability (K-MASA) |
K-MASA assesses 24 skills related to sensory and oral motor elements of swallowing. Performance for each skill is measured using a 5- or 10-points rating scale and tallied to create a total numeric score out of 200 possible points, which are interpreted as no abnormality (=178), mild dysphagia (168-177), moderate dysphagia (139-167) and severe (=138) |
Baseline, At 2, 4, and 8 weeks from baseline |
|
| Secondary |
Speech Mechanism Screening Test (SMST) |
The test consists of 13 questions to evaluate the structure of the articulatory system, including the face, lips, tongue, jaw, teeth, oral cavity, soft palate, pharynx, and breathing; 17 questions to evaluate the function of the articulatory system; 3 questions to auditorily evaluate the structure and function of the vocal system; and 14 questions to evaluate the regularity and articulation accuracy of the mutual movement of the articulatory system during articulatory alternation. |
Baseline, At 4, and 8 weeks from baseline |
|
| Secondary |
Urimal Test of Articulation and Phonology (U-TAP) |
U-TAP is a test designed for native speakers of the Korean language. It is aimed to evaluate the pronunciation produced in words and sentences by patients with speech sound disorders who have problems with consonant or vowel sounds. It is recorded by phonological word and syllable position and calculates consonant accuracy and word-level phonological indices at the word and sentence levels to compare with normal articulation development |
Baseline, At 4, and 8 weeks from baseline |
|
| Secondary |
modified Rankin Scale (mRS) |
mRS is composed of a 6-point assessment that includes reference to both limitations in activity and changes in lifestyle. The mRS possible scores vary from 0 (no symptoms) to 6 (dead) points |
Baseline, At 2, 4, and 8 weeks from baseline |
|
| Secondary |
Gugging Swallowing Screen |
The assessment is composed of two parts, the preliminary assessment (indirect swallowing test) and the direct swallowing test, which consist of 4 items with 3 subtests (semisolid, liquid and solid). The test is based on a pointing system where higher numbers denote better performance, with a maximum of 5 points that can be reached in each subtest. |
Baseline, At 2, 4, and 8 weeks from baseline |
|
| Secondary |
Eating Assessment Tool-10 (EAT-10) |
The EAT-10 is a tool to assess self-perceived symptoms of oropharyngeal dysphagia and monitor changes in response to a treatment. It consists of ten items to be rated on a 5-point response scale (0-4), with "0" = No problem and "4" = Severe problem, the maximum score possible is 40. |
Baseline, At 2, 4, and 8 weeks from baseline |
|
| Secondary |
Iowa Oral Performance Instrument (IOPI) |
IOPI is a standardized portable device that is used to quantify tongue and lips isometric strength and endurance. |
Baseline, At 4, and 8 weeks from baseline |
|
| Secondary |
Motor-Evoked Potential (MEP) |
The cortical excitability of the area corresponding to the swallowing movement will be assessed by changes in the amplitude and latency of the MEPs by using transcranial magnetic stimulation (TMS). |
Baseline, At 2 and 4 weeks from baseline |
|
| Secondary |
Grade, Roughness, Breathiness, Asthenia and Strain scale(GRBAS scale) |
GRBAS scale is used by researchers and clinicians for rating voice quality using a 4-point Likert scale with the following judgments: 0 = normal, 1 = mild impairment, 2 = moderate impairment, and 3 = severe impairment. |
Baseline, At 4, and 8 weeks from baseline |
|
| Secondary |
Respiratory muscle strength |
Respiratory muscle strength will be assessed by maximal inspiratory and expiratory pressure |
Baseline, At 4, and 8 weeks from baseline |
|
| Secondary |
Peak cough flow |
Peak cough flow measures the maximum expiratory flow during the compressive phase of a cough just after sudden opening of the glottis |
Baseline, At 4, and 8 weeks from baseline |
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