Effortful Swallow Maneuver for Swallowing Impairment in People With Parkinson Disease

Sponsor
University Health Network, Toronto (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05319795
Collaborator
(none)
12
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1
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Effortful Swallow Maneuver
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This is a prospective single arm case series treatment study involving a behavioral intervention (the Effortful Swallow Maneuver).This is a prospective single arm case series treatment study involving a behavioral intervention (the Effortful Swallow Maneuver).
Masking:
None (Open Label)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
Exploring the Efficacy of the Effortful Swallow Maneuver for Improving Swallowing in People With Parkinson Disease
Actual Study Start Date :
Mar 9, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Time-to-laryngeal-vestibule-closure [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 and 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst score per consistency will be recorded at each timepoint.

  2. Change in Penetration-Aspiration Scale Score [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 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.

  3. Change in pharyngeal area at maximum constriction [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). 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.

  4. Change in total pharyngeal residue [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. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Toronto Rehabilitation Institute - University Health Network Toronto Ontario Canada M5G 2A2
2 University Health Network Toronto Ontario Canada M5G 2C4

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

  • Principal Investigator: Catriona M Steele, PhD, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Catriona Steele, Scientist, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT05319795
Other Study ID Numbers:
  • CAPCR 21-5814
First Posted:
Apr 8, 2022
Last Update Posted:
May 19, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 19, 2022