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NCT Number: NCT07773025

Exploring the Efficacy of the Effortful Swallow Maneuver for Improving Swallowing in People With PD

The goal of this clinical trial is to learn whether a 4-week effortful swallow exercise program helps adults with Parkinson disease who have swallowing problems. The effortful swallow is a swallowing exercise where a person swallows with extra effort.

Researchers will compare adults who start the exercise program right away with adults who start the program after a 4-week waiting period. All participants who remain eligible will have the opportunity to receive the exercise program.

Participants will have swallowing assessments, including video X-ray swallowing tests called videofluoroscopy. They will also complete questionnaires and take part in a remotely supervised swallowing exercise program with a speech-language pathologist. Participants who remain eligible and take part in the exercise program will use a tongue pressure device during practice. The main study period lasts about 10 weeks. Participants will also complete brief follow-up questionnaires at 6 months and 12 months.

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Key information

Conditions

Dysphagia Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Otorhinolaryngologic Diseases Parkinson Disease Parkinson Disease (PD) Parkinsonian Disorders Pharyngeal Diseases Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This is a single-centre, randomized delayed-intervention study of a structured effortful swallow exercise program for adults with Parkinson disease and dysphagia. The effortful swallow is a swallowing exercise in which a person swallows with extra effort. The study is designed to evaluate whether a 4-week remotely supervised effortful swallow program can improve swallowing function.

Participants who remain eligible after baseline assessment will be randomly assigned to start the intervention right away or after a 4-week waiting period. This delayed-intervention design allows all eligible participants to receive the exercise program while also allowing researchers to compare swallowing outcomes between groups during the first 4 weeks.

The intervention will be delivered remotely by a speech-language pathologist. Participants will practise effortful swallow exercises at home and will use a tongue pressure device during practice to support measurement and feedback. Swallowing function will be assessed using videofluoroscopy, which is a video X-ray swallowing test. Participants will also complete questionnaires about swallowing and related health outcomes during the study and follow-up period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Neurologist-confirmed diagnosis of Parkinson disease
  • Self-report of one or more swallowing symptoms, such as difficulty managing secretions, coughing during meals, choking on food, or respiratory infection other than COVID-19 in the past 6 months
  • Baseline videofluoroscopic swallowing assessment showing prolonged time to laryngeal vestibule closure and/or poor pharyngeal area at maximum constriction on regular-effort swallows with thin or mildly thick liquid stimuli, relative to healthy reference values

Exclusion criteria

  • History of head and neck cancer
  • History of radical neck dissection, anterior cervical spine surgery, or neck/oropharyngeal surgery, except tonsillectomy or adenoidectomy
  • History of any neurological disease other than Parkinson disease
  • Cognitive or receptive communication difficulties that preclude the ability to follow English-language study instructions
  • History of brain surgery, including deep brain stimulation

Treatment and study plan

Effortful swallow

Behavioral

A 4-week remotely supervised swallowing exercise program delivered by a speech-language pathologist. Participants will practise effortful swallows at home using saliva and mildly thick liquids, according to study instructions. Participants will use a tongue pressure device during practice to support measurement and feedback. Participants may also complete home practice logs.

Primary outcomes

  1. Proportion of Participants With Improved Swallowing Function at Week 5

    Time frame: Baseline to Week 5

    Improved swallowing function will be defined using videofluoroscopic swallowing study findings. Participants will be classified as improved if they show improvement in Penetration-Aspiration Scale score and/or reduced pharyngeal residue at Week 5 compared with baseline. The primary comparison will be between the immediate intervention group and the delayed-intervention group at Week 5, before the delayed-intervention group begins the exercise program.

Secondary outcomes

  1. Proportion of Participants With Improved Swallowing Function or Physiology at Week 10

    Time frame: Baseline to Week 10

    Participants will be classified as improved if they show one or both of the following at Week 10 compared with baseline: shorter time to laryngeal vestibule closure in association with improvement in Penetration-Aspiration Scale score; and/or improved pharyngeal constriction in association with reduced pharyngeal residue. Pharyngeal constriction and residue will be measured from videofluoroscopy using pixel-based tracing normalized to cervical spine length.

  2. Change in Munich Dysphagia Test-Parkinson Disease Score

    Time frame: Baseline to Week 5, Week 10, 6 months, and 12 months

    Participant-reported swallowing symptoms will be measured using the Munich Dysphagia Test-Parkinson Disease questionnaire. Lower overall scores indicate improvement. Change from baseline will be assessed at Week 5, Week 10, 6 months, and 12 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Pooja Gandhi, PhD, R.SLP, SLP(C)

CONTACT

[email protected]

7804920596

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

EFFORT-PD: Exploring the Efficacy of the Effortful Swallow Maneuver for Improving Swallowing in People With Parkinson Disease

Acronym: EFFORT-PD

Important dates

Study start
2027
Primary completion
2029
Study completion
2030
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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