An interventional study of Effortful swallow in Dysphagia and Parkinson Disease (PD), sponsored by University of Alberta. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by University of Alberta · Not applicable, Interventional, and Treatment
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.
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.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 74 is above the median of 60 across 578 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →University of Alberta is the lead sponsor of 823 studies on the registry; 169 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Exclusion Criteria:
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.
Behavioral: Effortful swallow
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.
Behavioral: Effortful swallow
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.
Proportion of Participants With Improved Swallowing Function at 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.
Time frame: Baseline to Week 5
Proportion of Participants With Improved Swallowing Function or Physiology at 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.
Time frame: Baseline to Week 10
Change in Munich Dysphagia Test-Parkinson Disease Score
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.
Time frame: Baseline to Week 5, Week 10, 6 months, and 12 months
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared with other researchers. Results will be reported in aggregate form. The study includes sensitive clinical and videofluoroscopy-derived data, and the current consent and ethics approval do not include a plan for sharing de-identified individual participant data outside the approved study team.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Aug 2029, 31 months later.
Of 288 non-industry interventional studies with no phase under Deglutition Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's planned 31 months is above that.
Counting every sponsor, half of 297 studies reached it within 21 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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