Effortful Swallow Maneuver for Swallowing Impairment in People With Parkinson Disease

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

2 sites in 1 country.

About this study

Official title: Exploring the Efficacy of the Effortful Swallow Maneuver for Improving Swallowing in People With Parkinson Disease

Conditions

Parkinson Disease, Dysphagia

Being tested

Effortful Swallow Maneuver

Medical subject headings

Parkinson Disease, Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Effortful Swallow ManeuverBehavioural

  Repeated practice of the Effortful Swallowing Maneuver generated by pushing the tongue with increased effort against the palate at the point of swallow initiation.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

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

2. 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.

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

3. 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.

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

4. 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.

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

5. 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.

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

6. 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.

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

7. 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.

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

8. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted8 Apr 2022
2. Study start9 Mar 2022
3. Primary completion5 Jun 2023
4. Study completion5 Jun 2023

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
• More trials run by University Health Network, TorontoThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.