Parkinson's Disease Clinical Trial
Official title:
Masked Faces in Parkinson Disease: A Randomized Double-blind Sham-treatment Controlled Clinical Trial of High Intensity Respiratory Muscle Strength Training (MST) for Treatment of Reduced Facial Expression in Parkinson Disease
The purpose of this study is to examine the effectiveness of high intensity respiratory muscle strength training in treating blunted facial expression in people with Parkinson disease.
Facial expressions are complex signals that last only a few minutes and are important for
communicating intention, motivation, and emotional states. In humans, a variety of
neurological and psychiatric conditions alter the tendency to use facial signals. One of the
main symptoms of Parkinson disease (PD) is diminished facial expressivity or "masked
facies," which refers to the expressionless appearance of individuals with the disorder.
Unfortunately, little progress has been made over the years regarding the basis of "masked
faces" or strategies that might improve facial expressivity among individuals with PD. This
is unfortunate because the particular symptom can have significant medical and social
consequences ranging from misdiagnosis of depression to the misattribution of negative
emotional states and motivation by family members and healthcare providers.
The goal of this trial is to study the effectiveness of a novel, behavioral treatment
approach—high intensity respiratory muscle strength training (MST)—for blunting of facial
expressions in people with PD. The MST device, a mouthpiece that the participant uses to
inspire against resistance, may improve the strength and mobility of muscles around the
mouth that are involved in forming facial expressions.
Study participation includes screening, baseline evaluations, 4 weeks of behavioral
intervention, immediate post-treatment followup, and a 3-month follow-up. Participants will
be randomly assigned to take part in high intensity respiratory MST, or a Sham MST.
Participation in the study will last for approximately 5 months.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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