Improving airway protection in people with Parkinson's Disease
Rehabilitation of Airway Protection in Parkinson's Disease: Comparing In-person and Telehealth Service Delivery Models
This study is testing a new rehabilitation program to help people with Parkinson's Disease improve their swallowing and coughing skills, comparing in-person sessions to online ones.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Sponsor | Teachers College, Columbia University Academic / other |
| Locations | 2 sites (West Lafayette, Indiana and 1 other locations) |
| Trial ID | NCT05700825 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a novel rehabilitation approach for airway protection disorders in individuals with Parkinson's Disease (PD), specifically focusing on dysphagia and cough disorders. Participants will receive Expiratory Muscle Strength Training (EMST) and Cough Skill Training (CST) either in-person or via telehealth. The study aims to compare clinical outcomes and patient-centered results between these two delivery methods, addressing a significant gap in access to specialized care for this population. By evaluating treatment adherence and patient burden, the research seeks to enhance rehabilitation strategies for improving health outcomes in PD.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 50 to 90 diagnosed with Parkinson's Disease and experiencing airway protective deficits.
Not a fit: Patients with other neurological disorders, a history of head and neck cancer, or significant breathing disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life and health outcomes for patients with Parkinson's Disease by enhancing their airway protection.
How similar studies have performed: While there is limited research on telehealth delivery of these specific interventions, previous studies have shown promise in improving airway protection disorders in Parkinson's Disease.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Diagnosed with PD (Hoehn and Yahr Stages II-IV)126,127 confirmed by a Movement Disorders fellowship trained neurologist having reviewed the video recorded Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assessment for each participant and using strict UK brain bank criteria * airway protective deficits as defined as a minimum of penetration of thin liquids (penetration-aspiration score\>3) as determined by instrumental swallowing assessment and/or dystussia as determined by voluntary cough assessment (PEFR ≤4.1 L/s) * not actively receiving exercise-based swallowing therapy * between the ages of 50 and 90. Exclusion criteria: * Other neurological disorders (e.g., multiple sclerosis, stroke, brain tumor, etc.) * history of head and neck cancer * history of breathing disorders or diseases (e.g., COPD) * history of smoking in the last five years * uncontrolled hypertension * difficulty complying due to neuropsychological dysfunction (i.e., severe depression with \>28 on the Beck Depression Index (BDI-II), dementia with \<19 on the Montreal Cognitive Assessment (MoCA)) * allergy to capsaicin or barium * further than 1.5 hours (door to door) distance from either Teachers College, Columbia University or Purdue University.
Where this trial is running
West Lafayette, Indiana and 1 other locations
- Purdue University — West Lafayette, Indiana, United States (Recruiting)
- Teachers College, Columbia University — New York, New York, United States (Active_not_recruiting)
Study contacts
- Principal investigator: Michelle Troche, PhD — Teachers College, Columbia University
- Study coordinator: Michelle Troche, PhD
- Email: uadlab@tc.columbia.edu
- Phone: 212-678-3072
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.