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| ID | Type | Description | Link |
|---|---|---|---|
| FY24 HT942524PRPIIRA | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
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| United States Department of Defense | FED |
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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.
SwallowFIT: Subjects will receive 6-weeks of twice weekly SwallowFIT intervention per protocol (1-hour session each visit) from the BAMC speech language Pathologist (study SLP) at BAMC. Completion of the program will include 12 visits. The program is designed from a previous successful pilot trial. It begins with provision of general education on swallowing and swallowing change from the Parkinson's Foundation and Michael J Fox association websites.
Following this the program trains a modified effortful swallow technique at its onset using sEMG to guide the development of better swallow movement form, effort and performance. Once swallowing form is established, the program uses a hierarchy of swallowing tasks involving swallowing food/fluid materials at different complexity levels (swallow specificity) to stimulate and train progressive resistance and leverage variability of coordinated speeded actions.
Clinical Monitoring Only (CMO): This intervention mirrors the experimental intervention in all aspects, but the treatment type applied. CMO intervention reflects current swallow management practice for PD, where physicians monitor clinical function in swallowing and other related symptomology, referring for swallowing treatment only once an obvious issue has been identified.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SwallowFit Intervention | Experimental | Subjects randomized to intervention will receive 6-weeks of twice weekly SwallowFIT per protocol (1-hour session each day). The program begins with provision of general education on swallowing and swallowing change from the Parkinson's Foundation and Michael J Fox association websites. Following this the program trains a modified effortful swallow technique at its onset using surface electromyographic (sEMG) biofeedback to guide the development of better swallow movement form, effort and performance. From there it applies a hierarchy of swallowing exercises/tasks involving swallowing food/fluid materials at different complexity levels (swallow specificity) to stimulate and train progressive resistance and leverage variability of coordinated speeded actions. |
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| Clinical Monitoring Only (CMO) | No Intervention | CMO intervention reflects current swallow management practice for PD, where physicians monitor clinical function in swallowing and other related symptomology, referring for swallowing treatment only if an obvious issue has been identified. Subjects randomized to CMO will also receive general education on swallowing and swallow changes from the Parkinson's Foundation and Michael J Fox association websites. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SwallowFit | Behavioral | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to 6 months |
| 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. | Baseline to 6 months |
| 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. | Baseline to 6 months |
| 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. | Baseline to 6 months |
| PD Quality of Life Scale (PDQ-39) | The PDQ-39 is a questionnaire used to assess the impact of Parkinson's disease on quality of life. It consists of 39 questions, each rated on a 5-point scale from 0 (never) to 4 (always). Scores for the 39 questions are added to obtain a total score. The scores for the 8 subscales (mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and physical discomfort) are obtained by summing the scores for the relevant questions within each subscale. The total score and subscale scores range from 0 to 100, with higher scores indicating a greater impact of Parkinson's disease on quality of life. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giselle Carnaby, PhD, MPH | Contact | 210-450-7130 | carnaby@uthscsa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Giselle Carnaby, PhD, MP | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooke Army Medical Center (BAMC) | San Antonio | Texas | 78234-6200 | United States |
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| Label | URL |
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| Lab website for Principle Investigator regarding the study. | View source |
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The study team will report and publish in a peer-reviewed journal (trials journal) the study protocol and proposed analysis, to provide similar information to the national and international scientific community.
Information provision and awareness-raising will take place during project inception and intensify as results become available.
Study results will be published and displayed on the project webpage following completion of the 6 month follow up of all subjects.
After the study is complete and unblinded, the study team will submit all remaining scientific data to the data repository, and we will update the study status to "completed" in clinical trials.gov. According to the study timeline, all generated scientific data will approximately coincide with the submission of the results to clinicaltrials.gov and will occur no later than by the end of award. Scientific data included in published manuscripts will be available at the time of publication. According to the proposed project timeline, all generated scientific data will approximately coincide with the submission of the results to clinicaltrials.gov at the end of the award, and full data sharing (via repository) will occur no later than six months after completion of the study or acceptance for publication of the main findings from the final dataset.
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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A single site, double blind randomized controlled trial comparing a proactive swallow exercise intervention to a control group receiving clinical monitoring only (or CMO).
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Study investigators (PI, Co-I's, and Biostatistician), study coordinator and the Independent Evaluator, will be blind to the treatment allocation of the subjects. The PI will evaluate de-identified videoed assessments, and swallowing videofluoroscopic data.
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| Baseline to 6 months |
| Baseline to 6 months |
| 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. | Baseline to 6 months |
| 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. | Baseline to 6 months |
| 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 | Baseline to 6 months |
| Functional Oral Intake Scale (FOIS) | The Functional Oral Intake Scale (FOIS) is a 7-point ordinal scale used to assess a patient's ability to swallow and eat safely and efficiently. Scores range from 1 to 7, with higher scores indicating better swallowing function and a greater ability to participate in oral intake. | Baseline to 6 months |
| Lingual Pressure/movement | The Lingual Pressure Movement Scale, part of the AIMS (Abnormal Involuntary Movement Scale), assesses the severity of tongue movements. It uses a 0-4 scale, where 0 represents no movement, 1 represents minimal movement (may be extreme normal), 2 represents mild movement, 3 represents moderate movement, and 4 represents severe movement. | Baseline to 6 months |
| Sydney Swallowing Questionnaire (SSQ) | The Sydney Swallow Questionnaire (SSQ) is scored by summing the individual scores for each question. It consists of 17 questions, with most questions scored on a visual analog scale (VAS), ranging from 0 to 100 mm. The total possible score is 1700. Higher scores indicate more severe swallowing difficulties. | Baseline to 6 months |
| Protocol Adherence Measure | Percentage attendance measured by number of prescribed exercise sessions completed | Baseline to 6 months |
| Patient Perception of Swallowing (VAS) | In patient perception of swallowing, a Visual Analogue Scale (VAS) is used to assess a patient's subjective experience of swallowing difficulties. Patients mark a point on a line (typically 100 mm) that represents the severity of their swallowing problem, with 0 indicating no trouble and 100 indicating a total inability to swallow. | Baseline to 6 months |
| Patient/Caregiver Acceptability/Satisfaction Scale (PA/SS) | A 5 item scale where each item is scored on a Likert scale from 0-10. Total scores range from 0-50 with a higher score indicating that the SwallowFIT program was more helpful. | Baseline to 6 months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |