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

Sponsor
University of Alberta
Study ID
NCT07773025
Status
Not Yet Recruiting

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Conditions

  • Dysphagia
  • Parkinson Disease (PD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Aug 19, 2026
Start date
Jan 1, 2027
Status verified
Aug 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2030

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Immediate Intervention
    Participants assigned to this arm will begin the 4-week effortful swallow exercise program after baseline assessment. The program is delivered remotely by a speech-language pathologist. Participants will practise swallowing exercises at home and will use a tongue pressure device during practice. Participants will complete swallowing assessments and questionnaires during the study and follow-up period.
  • Other: Delayed Intervention
    Participants assigned to this arm will wait about 4 weeks before beginning the 4-week effortful swallow exercise program. During the waiting period, participants will continue usual clinical care as recommended by their health care team. After the waiting period, participants will receive the same remotely delivered effortful swallow exercise program as the immediate intervention group, including use of a tongue pressure device during practice.

Primary Outcome Measure

Proportion of Participants With Improved Swallowing Function at Week 5 [ Time Frame: Baseline to Week 5 ]

Central Contacts

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