NCT05319795

Effortful Swallow Maneuver for Swallowing Impairment in People With Parkinson Disease

Completed NA Results posted Last updated 29 July 2024

What this trial tests

NA trial testing Effortful Swallow Maneuver in Parkinson Disease in 5 participants. Completed in 5 June 2023.

Timeline

9 March 2022

Primary endpoint
5 June 2023

5 June 2023

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	9 March 2022
Primary completion	5 June 2023
Estimated completion	5 June 2023
Sites	2 locations across Canada

Drugs / interventions tested

• Effortful Swallow Maneuver

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →
• Dysphagia — all drugs for Dysphagia →

Sponsor

University Health Network, Toronto

Who can join

18 and older, any sex, with Parkinson Disease or Dysphagia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Time-to-laryngeal-vestibule-closure Thin Liquids Primary · 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.

Group	Value	95% CI
Effortful Swallow Maneuver	0	± 132

Change in Penetration-Aspiration Scale Score Thin Liquids Primary · 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) a

Group	Value	95% CI
Effortful Swallow Maneuver	0	± 1

Change in Pharyngeal Area at Maximum Constriction Thin Liquids Primary · 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

Group	Value	95% CI
Effortful Swallow Maneuver	-.12	± 2.5

Change in Total Pharyngeal Residue Thin Liquids Primary · 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 sco

Group	Value	95% CI
Effortful Swallow Maneuver	-.24	± 1.29

Change in Time-to-laryngeal-vestibule-closure Mildly Thick Liquids Primary · 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.

Group	Value	95% CI
Effortful Swallow Maneuver	33	± 198

Change in Penetration-Aspiration Scale Score Mildly Thick Liquids Primary · 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. hi

Group	Value	95% CI
Effortful Swallow Maneuver	-1	± 2

Change in Pharyngeal Area at Maximum Constriction Mildly Thick Liquids Primary · 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

Group	Value	95% CI
Effortful Swallow Maneuver	.28	± 1.5

Change in Total Pharyngeal Residue Mildly Thick Liquids Primary · 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 w

Group	Value	95% CI
Effortful Swallow Maneuver	-.5	± 1.07

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Exploring the Efficacy of the Effortful Swallow Maneuver for Improving Swallowing in People With Parkinson Disease-A Pilot Study.
   Gandhi P, Peladeau-Pigeon M, Simmons M, Steele CM. · · 2023 · cited 5× · PMID 37744193 · DOI 10.1016/j.arrct.2023.100276