The goal of this clinical trial is to learn if a proactive swallow exercise will help to improve swallow fitness in patients with Parkinson's disease.
The aim of the study is to assess how effective this exercise is and to measure the change in swallowing fitness from the beginning to the end of the study.
Patients who are given the exercise training will be compared to participants who are treated using the usual standard treatment.
Patients will have 6 weeks of twice-weekly SwallowFIT training. Each session will be an hour long.
Adult S-VWP between >35-90 years of age
Diagnosis of Idiopathic Parkinson's Disease [IDP] (either or suspected, tremor-predominant or rigid predominant)
Disability level of Hoehn & Yahr stages II-III as indicated in their most recent neurological evaluation
Swallowing concern, confirmed by Modified Unified Parkinson Disease Rating Scale [MDS-UPDRS]-
Classified as Hoehn and Yahr stages IV
Unable to follow 2 step commands
History of other neurological disease potentially causing dysphagia
Dementia (MMSE<20; Montreal cognitive assessment (MoCA) ≤ 20)
Parallel
SwallowFit
BehavioralThe SwallowFIT protocol follows an increasing task difficulty (levels on the hierarchy) and motor learning strategy. Progression on the hierarchy is guided and monitored by the occurrence of inefficiency markers in swallow wing (e.g. excessive lingual pumping, swallow hesitation, throat clearing etc.) confirmed from the baseline clinical and video fluoroscopic evaluations.
Mann Assessment of Swallowing Ability (MASA)
The MASA score is measured using a 5-point to 10-point rating scale. The total possible score of the MASA is 200 points, and the cutoff value is 177 points. The results of the MASA are interpreted as no abnormality (≥178), mild dysphagia (168-177), moderate dysphagia (139-167), and severe dysphagia (≤138).
Modified Unified Parkinson Disease Rating Scale (MDS-UPDRS)
The MDS-UPDRS uses a 0-4 scoring system, with higher scores indicating more severe symptoms. Parts I-III are scored on a 0-4 scale, while Part IV uses "yes" and "no" ratings. The total score range is 0-260, with 0 representing no disability and 260 representing total disability.
Modified Hoehn and Yahr (HY) Scale
The Hoehn and Yahr (H\&Y) scale is a grading system used to assess the progression and severity of motor symptoms in Parkinson's disease (PD). It ranges from Stage 0 (no signs of disease) to Stage 5 (severe disability, wheelchair or bed bound). Stages 1, 1.5, 2, and 2.5 are considered early stages, while stages 3, 4, and 5 represent later, more advanced stages.
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) is a cognitive screening tool with a maximum score of 30 points, with a score of 26 or higher generally indicating normal cognitive function. Scores between 18 and 25 may suggest mild cognitive impairment (MCI), while scores below 18 may indicate moderate to severe impairment.
Modified Barium Swallowing Impairment Profile, overall impression score (MBSImp OI score)
In the context of the Modified Barium Swallow Impairment Profile (MBSImP), Overall Impression (OI) scoring is the most common method used to assess swallowing physiology. It involves assigning a score to each of the 17 physiological components based on the most severe impairment observed across different swallowing tasks. These scores range from 0 to 4 depending on the component, and total scores range from 0-68 with higher scores indicating greater impairment.
Spontaneous Swallowing Frequency (SSF)
Spontaneous swallowing frequency (SSF) scoring refers to counting the number of times a person swallows without any specific prompting or external stimuli. It's a method used to assess swallowing function, particularly in conditions like dysphagia (difficulty swallowing), and can be a tool for screening and evaluating swallowing problems. A 5-10 minute sampling window is often used to calculate SSF. Healthy Swallowing: In healthy individuals, spontaneous swallowing typically occurs at a rate of 1-2 swallows per minute. Dysphagia: Patients with dysphagia often have a reduced SSF compared to healthy individuals. Thresholds: Some studies have suggested a threshold of 0.40 swallows per minute as a potential indicator of significant dysphagia.
Penetration Aspiration Scale (PAS)
The Penetration-Aspiration Scale (PAS) is an 8-point scale used to assess the depth and response to airway invasion during swallowing. It helps clinicians and researchers understand the severity of swallowing dysfunction by categorizing the location of the bolus within the airway and whether it's expelled or not. The scale is used in videofluoroscopic swallowing studies (VFSS) to quantify swallowing event. A score of 1 would indicate no material entered the airway while a score of 8 would indicate the most amount of material aspirated during swallowing.
Analysis of Swallowing Physiology: Events, Kinematics and Timing (ASPEKT)
Method of measuring physiologic kinematics and timing for swallowing images retrieved from modified barium swallow (MBSS). It evaluates of 8 key parameters of swallowing taken by frame analysis on open-source NIH, Image J software. Scoring of kinematic swallow movements will be evaluated using the published protocol
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The University of Texas Health Science Center at San Antonio
Lead sponsor
United States Department of Defense
Collaborator
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