Effortful Swallow Maneuver for Swallowing Impairment in People With Parkinson Disease

NCT05319795 | Completed Results

• 1 other identifier: CAPCR 21-5814
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease; Dysphagia

Outcome Measures

Primary Outcomes (8)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

Study Arms (1)

Effortful Swallow Maneuver

EXPERIMENTAL

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.

Behavioral: Effortful Swallow Maneuver

Interventions

Effortful Swallow Maneuver BEHAVIORAL

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

Effortful Swallow Maneuver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Difficulty with secretion management
• Coughing at the meal time
• Choking on food
• Respiratory infection in the past 6 months (other than COVID)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

Toronto Rehabilitation Institute - University Health Network

Toronto, Ontario, M5G 2A2, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

• Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.

  PMID: 8721066 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Deglutition Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Professor Catriona Steele
• Organization: University Health Network

catriona.steele@uhn.ca

4165973422

Study Officials

• Catriona M Steele, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Model Details: This is a prospective single arm case series treatment study involving a behavioral intervention (the Effortful Swallow Maneuver).

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 8, 2022
• Study Start: March 9, 2022
• Primary Completion: June 5, 2023
• Study Completion: June 5, 2023
• Last Updated: July 29, 2024
• Results First Posted: July 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)