Rehabilitation of Airway Protection in Parkinson's Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-90
SponsorTeachers College, Columbia University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Expiratory Muscle Strength Training + Cough Skill Training
BehavioralExpiratory 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: In-personActive comparator 1 intervention
Group B: TelehealthExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Peak Expiratory Flow Rate (Cough PEFR) - phase 1
Time frame
Pretraining to posttraining (after four weeks of intensive training)2
Change in Peak Expiratory Flow Rate (Cough PEFR) - phase 2
Time frame
post-training to post one-year maintenance3
Change in Penetration-Aspiration Scale (PAS) - phase 1
PAS, max value: 8 (most impaired), min value 1 (least impaired).
Time frame
Pretraining to posttraining (after four weeks of intensive training)4
Change in Penetration-Aspiration Scale (PAS) - phase 2
PAS, max value: 8 (most impaired), min value 1 (least impaired).
Time frame
post-training to post one-year maintenanceSecondary outcomes
1
Change in Maximum Expiratory Pressure - phase 1
Time frame
Pretraining to posttraining (after four weeks of intensive training)2
Change in Maximum Expiratory Pressure - phase 2
Time frame
post-training to post one-year maintenance3
Change in Cough expired volume - phase 1
Time frame
Pretraining to posttraining (after four weeks of intensive training)4
Change in Cough expired volume - phase 2
Time frame
post-training to post one-year maintenanceSponsors and contacts
Click on the lead sponsor to view all of their trials.
Teachers College, Columbia University
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Purdue University
Collaborator
Source ClinicalTrials.gov