N/A
N=5
Effortful Swallow Maneuver for Swallowing Impairment in People With Parkinson Disease
Parkinson Disease · Dysphagia
Bottom Line
View on ClinicalTrials.gov: NCT05319795 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Change in Time-to-laryngeal-vestibule-closure Thin Liquids — 0 milliseconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Effortful Swallow Maneuver (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Health Network, Toronto
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Time-to-laryngeal-vestibule-closure Thin Liquids |
— | — |
| PRIMARY Change in Penetration-Aspiration Scale Score Thin Liquids |
— | — |
| PRIMARY Change in Pharyngeal Area at Maximum Constriction Thin Liquids |
-.12 | — |
| PRIMARY Change in Total Pharyngeal Residue Thin Liquids |
-.24 | — |
| PRIMARY Change in Time-to-laryngeal-vestibule-closure Mildly Thick Liquids |
33 | — |
| PRIMARY Change in Penetration-Aspiration Scale Score Mildly Thick Liquids |
-1 | — |
| PRIMARY Change in Pharyngeal Area at Maximum Constriction Mildly Thick Liquids |
.28 | — |
| PRIMARY Change in Total Pharyngeal Residue Mildly Thick Liquids |
-.5 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05319795). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.