Dysphagia, Parkinson Disease
Conditions
Brief summary
Context: Many people with Parkinson Disease (PwPD) experience swallowing difficulties, particularly with food/liquid going down the wrong way or remaining in the throat after swallowing. Prior studies suggest that exercise-based treatments targeting swallowing strength may be effective in reducing these difficulties. Research question: Does an exercise-based treatment involving the effortful swallow maneuver improve swallowing function in PwPD? Study plan: The investigators will study the effects of a four-week intensive swallowing rehabilitation program in PwPD, over a 2-year period.
Detailed description
The investigators will study the effects of a four-week intensive swallowing rehabilitation program in PwPD, over a 2 year period. The program will involve daily practice of the effortful swallowing maneuver, with swallowing function assessed before and after the treatment program using videofluoroscopic x-rays. Expected outcomes: In other populations, the effortful swallow has shown to address two mechanisms that are thought to underlie swallowing impairment in Parkinson Disease: slowness in achieving airway protection and weakness in muscles responsible for transporting food through the throat. The investigators expect that repeated practice of this maneuver by PwPD will lead to improved airway protection and improved clearance of residue from the throat.
Interventions
BEHAVIORALEffortful Swallow Maneuver
Repeated practice of the Effortful Swallowing Maneuver generated by pushing the tongue with increased effort against the palate at the point of swallow initiation.
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is a single arm study. However, individuals responsible for rating the videofluoroscopy x-ray data to determine outcomes will be blinded to timepoint of evaluation.
Intervention model description
This is a prospective single arm case series treatment study involving a behavioral intervention (the Effortful Swallow Maneuver).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years old * English-speaking * Able to follow study instructions * Neurologist confirmed diagnosis of PD * Hoehn and Yahr scale score of 2 or 3 * Self-report of one or more swallowing or related symptoms: 1. Difficulty with secretion management 2. Coughing at the meal time 3. Choking on food 4. Respiratory infection in the past 6 months (other than COVID)
Exclusion criteria
* History of head and neck cancer * Radical neck dissection (e.g. anterior cervical spine surgery) or neck/ oropharyngeal surgery (not excluded - tonsillectomy, adenoidectomy) * Past medical history of any neurological disease other than PD (e.g. multiple sclerosis, amyotrophic lateral sclerosis, traumatic brain injury, stroke) * Cognitive or receptive communication difficulties that preclude the participant's ability to follow study instructions provided in English. This will be determined by the participant's physician prior to referring them to the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Time-to-laryngeal-vestibule-closure Thin Liquids | Post treatment (4 weeks) compared to pre-treatment baseline | The time interval (in milliseconds) measured on a videofluoroscopic x-ray of swallowing between onset of the hyoid burst movement at the beginning of a swallow and achieving airway protection via closure of the laryngeal vestibule. The investigators will measure time-to-laryngeal-vestibule-closure across a series of 3 thin liquid swallows in videofluoroscopy. The participant's worst score (i.e. longest) across these 3 task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated. |
| Change in Penetration-Aspiration Scale Score Thin Liquids | Post treatment (4 weeks) compared to pre-treatment baseline | The Penetration-Aspiration Scale is an 8-point ordinal scale, measured on a videofluorosopic x-ray of swallowing, which documents the depth of any airway invasion events, and the subsequent response to airway invasion (Rosenbek et al., 1996). The scale ranges from a minimum score of 1 (no airway invasion) to a maximum score of 8 (entry of material below the true vocal folds with no response and no ejection). Higher scores are worse. The investigators will measure penetration-aspiration across a series of 3 thin liquid swallows in videofluoroscopy. The participant's worst score (i.e. highest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated. |
| Change in Pharyngeal Area at Maximum Constriction Thin Liquids | Post treatment (4 weeks) compared to pre-treatment baseline | A videofluoroscopic measure of the degree of pharyngeal constriction during swallowing (i.e. maximum obliteration of the space in the pharynx). This measure is obtained from pixel-based measures of the unobliterated area of the pharynx on a lateral view x-ray image at the point of maximum constriction. The number of pixels is divided by an anatomical reference scalar defined by the squared length of the distance, in pixels, between the anterior inferior corners of the C2 and C4 cervical vertebrae on the same image. The investigators will measure pharyngeal area at maximum constriction across a series of 3 thin liquid swallows in videofluoroscopy. The participant's worst score (i.e. largest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated. |
| Change in Total Pharyngeal Residue Thin Liquids | Post treatment (4 weeks) compared to pre-treatment baseline | A videofluoroscopic measure of the amount of residue left behind in the pharynx after a swallow. This measure is obtained from pixel-based measures of the area of residue in the pharynx on a lateral view x-ray image at the end of the swallow. The number of pixels is divided by an anatomical reference scalar defined by the squared length of the distance, in pixels, between the anterior inferior corners of the C2 and C4 cervical vertebrae on the same image. The investigators will measure pharyngeal residue across a series of 3 thin liquid swallows in videofluoroscopy. The participant's worst score (i.e. largest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated. |
| Change in Time-to-laryngeal-vestibule-closure Mildly Thick Liquids | Post treatment (4 weeks) compared to pre-treatment baseline | The time interval (in milliseconds) measured on a videofluoroscopic x-ray of swallowing between onset of the hyoid burst movement at the beginning of a swallow and achieving airway protection via closure of the laryngeal vestibule. The investigators will measure time-to-laryngeal-vestibule-closure across a series of 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst score (i.e. longest) across these 3 task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated. |
| Change in Penetration-Aspiration Scale Score Mildly Thick Liquids | Post treatment (4 weeks) compared to pre-treatment baseline | The Penetration-Aspiration Scale is an 8-point ordinal scale, measured on a videofluorosopic x-ray of swallowing, which documents the depth of any airway invasion events, and the subsequent response to airway invasion (Rosenbek et al., 1996). The scale ranges from a minimum score of 1 (no airway invasion) to a maximum score of 8 (entry of material below the true vocal folds with no response and no ejection). Higher scores are worse. The investigators will measure penetration-aspiration across a series of 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst score (i.e. highest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated. |
| Change in Pharyngeal Area at Maximum Constriction Mildly Thick Liquids | Post treatment (4 weeks) compared to pre-treatment baseline | A videofluoroscopic measure of the degree of pharyngeal constriction during swallowing (i.e. maximum obliteration of the space in the pharynx). This measure is obtained from pixel-based measures of the unobliterated area of the pharynx on a lateral view x-ray image at the point of maximum constriction. The number of pixels is divided by an anatomical reference scalar defined by the squared length of the distance, in pixels, between the anterior inferior corners of the C2 and C4 cervical vertebrae on the same image. The investigators will measure pharyngeal area at maximum constriction across a series of 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst score (i.e. largest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated. |
| Change in Total Pharyngeal Residue Mildly Thick Liquids | Post treatment (4 weeks) compared to pre-treatment baseline | A videofluoroscopic measure of the amount of residue left behind in the pharynx after a swallow. This measure is obtained from pixel-based measures of the area of residue in the pharynx on a lateral view x-ray image at the end of the swallow. The number of pixels is divided by an anatomical reference scalar defined by the squared length of the distance, in pixels, between the anterior inferior corners of the C2 and C4 cervical vertebrae on the same image. The investigators will measure pharyngeal residue across a series of 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst score (i.e. largest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Effortful Swallow Maneuver Adults with a confirmed diagnosis of Parkinson Disease who have radiographically confirmed difficulties with timely airway protection and/or bolus clearance during swallowing. Individuals will complete a 4-week intervention program with two 30-minute sessions of Effortful Swallow (ES) practice daily, 5 days per week.
Effortful Swallow Maneuver: Repeated practice of the Effortful Swallowing Maneuver generated by pushing the tongue with increased effort against the palate at the point of swallow initiation. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Effortful Swallow Maneuver |
|---|---|
| Age, Continuous | 70 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment Canada | 5 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Change in Penetration-Aspiration Scale Score Mildly Thick Liquids
The Penetration-Aspiration Scale is an 8-point ordinal scale, measured on a videofluorosopic x-ray of swallowing, which documents the depth of any airway invasion events, and the subsequent response to airway invasion (Rosenbek et al., 1996). The scale ranges from a minimum score of 1 (no airway invasion) to a maximum score of 8 (entry of material below the true vocal folds with no response and no ejection). Higher scores are worse. The investigators will measure penetration-aspiration across a series of 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst score (i.e. highest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Time frame: Post treatment (4 weeks) compared to pre-treatment baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Effortful Swallow Maneuver | Change in Penetration-Aspiration Scale Score Mildly Thick Liquids | -1 score on a scale | Standard Deviation 2 |
Primary
Change in Penetration-Aspiration Scale Score Thin Liquids
The Penetration-Aspiration Scale is an 8-point ordinal scale, measured on a videofluorosopic x-ray of swallowing, which documents the depth of any airway invasion events, and the subsequent response to airway invasion (Rosenbek et al., 1996). The scale ranges from a minimum score of 1 (no airway invasion) to a maximum score of 8 (entry of material below the true vocal folds with no response and no ejection). Higher scores are worse. The investigators will measure penetration-aspiration across a series of 3 thin liquid swallows in videofluoroscopy. The participant's worst score (i.e. highest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Time frame: Post treatment (4 weeks) compared to pre-treatment baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Effortful Swallow Maneuver | Change in Penetration-Aspiration Scale Score Thin Liquids | 0 score on a scale | Standard Deviation 1 |
Primary
Change in Pharyngeal Area at Maximum Constriction Mildly Thick Liquids
A videofluoroscopic measure of the degree of pharyngeal constriction during swallowing (i.e. maximum obliteration of the space in the pharynx). This measure is obtained from pixel-based measures of the unobliterated area of the pharynx on a lateral view x-ray image at the point of maximum constriction. The number of pixels is divided by an anatomical reference scalar defined by the squared length of the distance, in pixels, between the anterior inferior corners of the C2 and C4 cervical vertebrae on the same image. The investigators will measure pharyngeal area at maximum constriction across a series of 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst score (i.e. largest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Time frame: Post treatment (4 weeks) compared to pre-treatment baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Effortful Swallow Maneuver | Change in Pharyngeal Area at Maximum Constriction Mildly Thick Liquids | .28 percentage of the C2-4 anatomical scalar | Standard Deviation 1.5 |
Primary
Change in Pharyngeal Area at Maximum Constriction Thin Liquids
A videofluoroscopic measure of the degree of pharyngeal constriction during swallowing (i.e. maximum obliteration of the space in the pharynx). This measure is obtained from pixel-based measures of the unobliterated area of the pharynx on a lateral view x-ray image at the point of maximum constriction. The number of pixels is divided by an anatomical reference scalar defined by the squared length of the distance, in pixels, between the anterior inferior corners of the C2 and C4 cervical vertebrae on the same image. The investigators will measure pharyngeal area at maximum constriction across a series of 3 thin liquid swallows in videofluoroscopy. The participant's worst score (i.e. largest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Time frame: Post treatment (4 weeks) compared to pre-treatment baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Effortful Swallow Maneuver | Change in Pharyngeal Area at Maximum Constriction Thin Liquids | -.12 percentage of the C2-4 anatomical scalar | Standard Deviation 2.5 |
Primary
Change in Time-to-laryngeal-vestibule-closure Mildly Thick Liquids
The time interval (in milliseconds) measured on a videofluoroscopic x-ray of swallowing between onset of the hyoid burst movement at the beginning of a swallow and achieving airway protection via closure of the laryngeal vestibule. The investigators will measure time-to-laryngeal-vestibule-closure across a series of 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst score (i.e. longest) across these 3 task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Time frame: Post treatment (4 weeks) compared to pre-treatment baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Effortful Swallow Maneuver | Change in Time-to-laryngeal-vestibule-closure Mildly Thick Liquids | 33 milliseconds | Standard Deviation 198 |
Primary
Change in Time-to-laryngeal-vestibule-closure Thin Liquids
The time interval (in milliseconds) measured on a videofluoroscopic x-ray of swallowing between onset of the hyoid burst movement at the beginning of a swallow and achieving airway protection via closure of the laryngeal vestibule. The investigators will measure time-to-laryngeal-vestibule-closure across a series of 3 thin liquid swallows in videofluoroscopy. The participant's worst score (i.e. longest) across these 3 task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Time frame: Post treatment (4 weeks) compared to pre-treatment baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Effortful Swallow Maneuver | Change in Time-to-laryngeal-vestibule-closure Thin Liquids | 0 milliseconds | Standard Deviation 132 |
Primary
Change in Total Pharyngeal Residue Mildly Thick Liquids
A videofluoroscopic measure of the amount of residue left behind in the pharynx after a swallow. This measure is obtained from pixel-based measures of the area of residue in the pharynx on a lateral view x-ray image at the end of the swallow. The number of pixels is divided by an anatomical reference scalar defined by the squared length of the distance, in pixels, between the anterior inferior corners of the C2 and C4 cervical vertebrae on the same image. The investigators will measure pharyngeal residue across a series of 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst score (i.e. largest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Time frame: Post treatment (4 weeks) compared to pre-treatment baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Effortful Swallow Maneuver | Change in Total Pharyngeal Residue Mildly Thick Liquids | -.5 percentage of the C2-4 anatomical scalar | Standard Deviation 1.07 |
Primary
Change in Total Pharyngeal Residue Thin Liquids
A videofluoroscopic measure of the amount of residue left behind in the pharynx after a swallow. This measure is obtained from pixel-based measures of the area of residue in the pharynx on a lateral view x-ray image at the end of the swallow. The number of pixels is divided by an anatomical reference scalar defined by the squared length of the distance, in pixels, between the anterior inferior corners of the C2 and C4 cervical vertebrae on the same image. The investigators will measure pharyngeal residue across a series of 3 thin liquid swallows in videofluoroscopy. The participant's worst score (i.e. largest) across these three task repetitions will be recorded at each timepoint and the difference across timepoints will be calculated.
Time frame: Post treatment (4 weeks) compared to pre-treatment baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Effortful Swallow Maneuver | Change in Total Pharyngeal Residue Thin Liquids | -.24 percentage of the C2-4 anatomical scalar | Standard Deviation 1.29 |