SwallowFIT for Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to learn if a proactive swallow exercise will help to improve swallow fitness in patients with Parkinson's disease.
The aim of the study is to assess how effective this exercise is and to measure the change in swallowing fitness from the beginning to the end of the study.
Patients who are given the exercise training will be compared to participants who are treated using the usual standard treatment.
Patients will have 6 weeks of twice-weekly SwallowFIT training. Each session will be an hour long.
Who Is on the Research Team?
Giselle Carnaby, PhD, MP
Principal Investigator
The University of Texas Health Science Center at San Antonio
Are You a Good Fit for This Trial?
This trial is for individuals with Parkinson's Disease who are interested in improving their swallowing ability. Participants will engage in a proactive swallow exercise program over 6 weeks, with sessions twice a week.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 6 weeks of twice-weekly SwallowFIT training, each session lasting one hour
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- SwallowFit
Trial Overview
The SwallowFIT study tests if special swallow exercises can improve swallowing fitness in Parkinson’s patients compared to those receiving standard treatment. The effectiveness of the exercises will be measured from start to end of the study.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Subjects randomized to intervention will receive 6-weeks of twice weekly SwallowFIT per protocol (1-hour session each day). The program begins with provision of general education on swallowing and swallowing change from the Parkinson's Foundation and Michael J Fox association websites. Following this the program trains a modified effortful swallow technique at its onset using surface electromyographic (sEMG) biofeedback to guide the development of better swallow movement form, effort and performance. From there it applies a hierarchy of swallowing exercises/tasks involving swallowing food/fluid materials at different complexity levels (swallow specificity) to stimulate and train progressive resistance and leverage variability of coordinated speeded actions.
CMO intervention reflects current swallow management practice for PD, where physicians monitor clinical function in swallowing and other related symptomology, referring for swallowing treatment only if an obvious issue has been identified. Subjects randomized to CMO will also receive general education on swallowing and swallow changes from the Parkinson's Foundation and Michael J Fox association websites.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San Antonio
Lead Sponsor
United States Department of Defense
Collaborator
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