EFFORT-PD: Exploring the Efficacy of the Effortful Swallow Maneuver for Improving Swallowing in People With Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 74
- 主要终点
- Proportion of Participants With Improved Swallowing Function at Week 5
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Proportion of Participants With Improved Swallowing Function at Week 5
时间窗: 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.
次要结局
- Proportion of Participants With Improved Swallowing Function or Physiology at Week 10(Baseline to Week 10)
- Change in Munich Dysphagia Test-Parkinson Disease Score(Baseline to Week 5, Week 10, 6 months, and 12 months)
研究者
Pooja Gandhi
Assistant Professor
University of Alberta