SwallowFIT Study in Parkinson's Disease

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT07356414
Status
Not Yet Recruiting

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Conditions

  • PARKINSON DISEASE (Disorder)

Eligibility Criteria

Sex
ALL
Age
35 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • SwallowFit — BEHAVIORAL
    The SwallowFIT protocol follows an increasing task difficulty (levels on the hierarchy) and motor learning strategy. Progression on the hierarchy is guided and monitored by the occurrence of inefficiency markers in swallow wing (e.g. excessive lingual pumping, swallow hesitation, throat clearing etc.) confirmed from the baseline clinical and video fluoroscopic evaluations.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Mar 30, 2028
Completion
Jun 29, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SwallowFit Intervention
    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.
  • No Intervention: Clinical Monitoring Only (CMO)
    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.

Primary Outcome Measure

Mann Assessment of Swallowing Ability (MASA) [ Time Frame: Baseline to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brooke Army Medical Center (BAMC)San AntonioTexas78234-6200
Giselle Carnaby, PhD, MPH
[email protected]
210-450-7130
Alexis Nelson
210-916-2203.

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By research site
Brooke Army Medical Center (BAMC)· San Antonio, TX

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