Clinical trial NCT05319795: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Dysphagia
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective single arm case series treatment study involving a behavioral intervention (the Effortful Swallow Maneuver).
Primary purpose: TREATMENT

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.

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:

  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.

Primary outcomes:
measure: Change in Time-to-laryngeal-vestibule-closure Thin Liquids
timeFrame: Post treatment (4 weeks) compared to pre-treatment baseline
measure: Change in Penetration-Aspiration Scale Score Thin Liquids
timeFrame: Post treatment (4 weeks) compared to pre-treatment baseline
measure: Change in Pharyngeal Area at Maximum Constriction Thin Liquids
timeFrame: Post treatment (4 weeks) compared to pre-treatment baseline
measure: Change in Total Pharyngeal Residue Thin Liquids
timeFrame: Post treatment (4 weeks) compared to pre-treatment baseline
measure: Change in Time-to-laryngeal-vestibule-closure Mildly Thick Liquids
timeFrame: Post treatment (4 weeks) compared to pre-treatment baseline
measure: Change in Penetration-Aspiration Scale Score Mildly Thick Liquids
timeFrame: Post treatment (4 weeks) compared to pre-treatment baseline
measure: Change in Pharyngeal Area at Maximum Constriction Mildly Thick Liquids
timeFrame: Post treatment (4 weeks) compared to pre-treatment baseline
measure: Change in Total Pharyngeal Residue Mildly Thick Liquids
timeFrame: Post treatment (4 weeks) compared to pre-treatment baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute - University Health Network
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Catriona M Steele, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.