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Recruiting
NCT05700825
Rehabilitation of Airway Protection in Parkinson's Disease
Conditions: Parkinson Disease, Dysphagia
Sex: All
Ages: 50 Years – 90 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 120
Sponsor: Teachers College, Columbia University
Location: Purdue University West Lafayette Indiana
Summary
Airway protective disorders are a prevalent and progressive consequence of Parkinson's Disease (PD), and often result in aspiration pneumonia which is the leading cause of death in PD. Despite this, a large number of patients with PD do not access specialized services to address these critical deficits. The investigators will examine the comparative effectiveness of a novel treatment paradigm delivered in-person versus via telehealth in persons with PD, as well as the role of patient burden and treatment adherence on outcomes; thus, the proposed research is relevant to public health and in line with NIH's mission to identify novel, efficacious, and accessible rehabilitation strategies for short- and long-term improvement of dysfunctional airway protection in PD.
Eligibility 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 \
Source: ClinicalTrials.gov (NCT05700825). StuddyBuddy aggregates publicly available trial information.