Effortful Swallow Maneuver for Swallowing Impairment in People With Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05319795
• Other study ID #: CAPCR 21-5814
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 9, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dysphagia
• Parkinson Disease

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	Toronto Rehabilitation Institute - University Health Network	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Time-to-laryngeal-vestibule-closure	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 and 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst score per consistency will be recorded at each timepoint.	Post treatment (4 weeks) compared to pre-treatment baseline
Primary	Change in Penetration-Aspiration Scale Score	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 investigators will measure penetration-aspiration across a series of 3 thin liquid swallows and 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst (i.e., highest) score per consistency will be recorded at each timepoint.	Post treatment (4 weeks) compared to pre-treatment baseline
Primary	Change in pharyngeal area at maximum constriction	A videofluoroscopic measure of the degree of pharyngeal constriction during swallowing (i.e. maximum obliteration of the space in the pharynx). The investigators will measure pharyngeal area at maximum constriction across a series of 3 thin liquid swallows and 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst (i.e., highest) score per consistency will be recorded at each timepoint.	Post treatment (4 weeks) compared to pre-treatment baseline
Primary	Change in total pharyngeal residue	A videofluoroscopic measure of the amount of residue left behind in the pharynx after a swallow. The investigators will measure pharyngeal residue across a series of 3 thin liquid swallows and 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst (i.e., highest) score per consistency will be recorded at each timepoint.	Post treatment (4 weeks) compared to pre-treatment baseline