Dysphagia, Parkinson Disease (PD)
Conditions
Keywords
Dysphagia, Parkinson disease, effortful swallow
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALEffortful 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.
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and study personnel delivering the intervention will not be masked because the intervention is a swallowing exercise program. Outcome assessors who rate videofluoroscopy recordings for research outcomes will be masked to group assignment and study time point when feasible.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Improved Swallowing Function at Week 5 | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Improved Swallowing Function or Physiology at Week 10 | 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. |
| Change in Munich Dysphagia Test-Parkinson Disease Score | 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. |
Contacts
CONTACTPooja Gandhi, PhD, R.SLP, SLP(C)
Outcome results
None listed