What this study is
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.
What's being tested
- Expiratory Muscle Strength Training + Cough Skill Training
Intervention · BEHAVIORAL
Expiratory Muscle Strength Training (EMST). EMST is a widely used and efficacious treatment approach that uses a calibrated device with a one-way, spring-loaded pressure relief valve to mechanically overload the expiratory and submental muscles. Cough Skill Training (CST) involves a digital peak flow meter device which measures PEFR (peak expiratory flow rate) in liters/second and allows patients to receive immediate biofeedback.
Study details
- Official title
- Rehabilitation of Airway Protection in Parkinson's Disease: Comparing In-person and Telehealth Service Delivery Models
- Sponsor
- Teachers College, Columbia University
- Conditions
- Parkinson Disease · Dysphagia
- Enrolling
- 120 people
- Starts
- 2022-08-11
- Est. completion
- 2027-09-01
- Design
- Double-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 50 Years – 90 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
1 openTeachers College, Columbia University
New York, New York, United States
- Michelle Troche, PhD · Contact212-678-3072mst2139@tc.columbia.edu
RecruitingPurdue University
West Lafayette, Indiana, United States
Active, not recruiting
Study team
Sponsor
Teachers College, Columbia University
Study ID NS126319
Principal investigator
Michelle Troche, PhD
Teachers College, Columbia University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.