At a glance
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Effects of Device-Facilitated Isometric Progressive Resistance Oropharyngeal (I-PRO) Therapy on Dysphagia Related Outcomes in Patients Post-stroke
In Brief
A clinical study evaluating Isometric Progressive Resistance Oropharyngeal Therapy and Compensatory approaches for Stroke. Completed, enrolled 30 participants across 1 site.
Detailed Summary
The overall goal of this randomized controlled pilot study is to characterize effects of SwallowSTRONG® Device-Facilitated Isometric Progressive Resistance Oropharyngeal (DF I-PRO) therapy in a dose response framework on swallowing-related outcomes in a group of unilateral ischemic stroke patients. These results will be used to determine adequate sample size in order to support a larger clinical trial focused on the efficacy of this therapy approach for improving swallowing safety. The first aim is to determine differences in swallowing physiology and bolus flow measures a) between a group of unilateral ischemic stroke subjects undergoing SwallowSTRONG® DF I-PRO therapy and controls and b) between 8 and 12 weeks of treatment. The second aim is to examine changes in level of oral intake and swallowing quality of life in post-stroke patients undergoing DF I-PRO therapy as compared to a control group and as they relate to treatment duration response at 8 weeks and 12 weeks. The third aim is to evaluate effects of DF I-PRO therapy on overall health status reflected by the number of pneumonia diagnoses and overall hospital readmission rates in post-stroke subjects undergoing DF I-PRO therapy compared to controls.
Study Details
Timeline
Interventions
Isometric Progressive Resistance Oropharyngeal Therapy is an approach to oropharyngeal strengthening. This particular use of I-PRO therapy will be facilitated by the Swallow Strong device.