Back to resultsEffortful Swallow Maneuver for Swallowing Impairment in People With Parkinson Disease
Primary Purpose
Parkinson Disease, Dysphagia
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Effortful Swallow Maneuver
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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:
- Difficulty with secretion management
- Coughing at the meal time
- Choking on food
- 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.
Sites / Locations
- Toronto Rehabilitation Institute - University Health Network
- University Health Network
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Effortful Swallow Maneuver
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05319795
First Posted
March 31, 2022
Last Updated
May 16, 2022
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT05319795
Brief Title
Effortful Swallow Maneuver for Swallowing Impairment in People With Parkinson Disease
Official Title
Exploring the Efficacy of the Effortful Swallow Maneuver for Improving Swallowing in People With Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Dysphagia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Effortful Swallow Maneuver
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Effortful Swallow Maneuver
Intervention Description
Repeated practice of the Effortful Swallowing Maneuver generated by pushing the tongue with increased effort against the palate at the point of swallow initiation.
Primary Outcome Measure Information:
Title
Change in Time-to-laryngeal-vestibule-closure
Description
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.
Time Frame
Post treatment (4 weeks) compared to pre-treatment baseline
Title
Change in Penetration-Aspiration Scale Score
Description
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.
Time Frame
Post treatment (4 weeks) compared to pre-treatment baseline
Title
Change in pharyngeal area at maximum constriction
Description
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.
Time Frame
Post treatment (4 weeks) compared to pre-treatment baseline
Title
Change in total pharyngeal residue
Description
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.
Time Frame
Post treatment (4 weeks) compared to pre-treatment baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Difficulty with secretion management
Coughing at the meal time
Choking on food
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catriona M Steele, PhD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Rehabilitation Institute - University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2A2
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
8721066
Citation
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.
Results Reference
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Effortful Swallow Maneuver for Swallowing Impairment in People With Parkinson Disease
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