Effortful Swallow Maneuver for Swallowing Impairment in People With Parkinson Disease

NCT ID: NCT05319795

Last Updated: 2024-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-09
• Study Completion Date: 2023-06-05

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.

Conditions

Parkinson Disease; Dysphagia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Effortful Swallow Maneuver

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Catriona Steele

Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catriona M Steele, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Toronto Rehabilitation Institute - University Health Network

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 8721066 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CAPCR 21-5814

Identifier Type: -

Identifier Source: org_study_id