Trial Outcomes & Findings for Effortful Swallow Maneuver for Swallowing Impairment in People With Parkinson Disease (NCT NCT05319795)

NCT ID: NCT05319795

Last Updated: 2024-07-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

Post treatment (4 weeks) compared to pre-treatment baseline

Results posted on

2024-07-29

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effortful Swallow Maneuver for Swallowing Impairment in People With Parkinson Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Effortful Swallow Maneuver n=5 Participants 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.
Age, Continuous	70 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Canada	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Effortful Swallow Maneuver n=5 Participants 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.
Change in Time-to-laryngeal-vestibule-closure Thin Liquids	0 milliseconds Standard Deviation 132

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Effortful Swallow Maneuver n=5 Participants 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.
Change in Penetration-Aspiration Scale Score Thin Liquids	0 score on a scale Standard Deviation 1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Effortful Swallow Maneuver n=5 Participants 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.
Change in Pharyngeal Area at Maximum Constriction Thin Liquids	-.12 percentage of the C2-4 anatomical scalar Standard Deviation 2.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Effortful Swallow Maneuver n=5 Participants 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.
Change in Total Pharyngeal Residue Thin Liquids	-.24 percentage of the C2-4 anatomical scalar Standard Deviation 1.29

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Effortful Swallow Maneuver n=5 Participants 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.
Change in Time-to-laryngeal-vestibule-closure Mildly Thick Liquids	33 milliseconds Standard Deviation 198

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Effortful Swallow Maneuver n=5 Participants 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.
Change in Penetration-Aspiration Scale Score Mildly Thick Liquids	-1 score on a scale Standard Deviation 2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Effortful Swallow Maneuver n=5 Participants 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.
Change in Pharyngeal Area at Maximum Constriction Mildly Thick Liquids	.28 percentage of the C2-4 anatomical scalar Standard Deviation 1.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Effortful Swallow Maneuver n=5 Participants 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.
Change in Total Pharyngeal Residue Mildly Thick Liquids	-.5 percentage of the C2-4 anatomical scalar Standard Deviation 1.07

Adverse Events

Effortful Swallow Maneuver

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Catriona Steele

University Health Network

Phone: 4165973422

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place