Effects of Oropharyngeal Strengthening on Dysphagia in Patients Post-stroke
Completed · Not applicable
Conditions studied: Stroke
In brief
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.
Key facts
- Study ID
- NCT02322411
- Run by
- University of Wisconsin, Madison
- People needed
- 30
- Starts
- 2015-01-01
- Expected to finish
- 2017-10-19
- Last updated by the study team
- 2020-07-15
Who can join
Age: 21 and older, up to 95. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- clinical diagnosis of unilateral ischemic strokes by attending physician (according to the National Institute of Health Stroke Scale (NIHSS))
- within 6 months of acute stroke diagnosis
- a score of 3 or higher on the Penetration-Aspiration scale OR a score of 2 on the Residue scale at any location (oral cavity, valleculae, or pharynx) that is instrumentally documented by a participating SLP during a standardized videofluoroscopic swallowing study
- between the ages of 21 and 95
- ability to perform the strengthening protocol independently or with the assistance of a caregiver
- physician approval of medical stability to participate
- decision-making capacity to provide informed consent (confirmed through discussion with the subject's primary physician)
- phone access
- ability to return to the clinic for required follow-up appointments.
You may not qualify if…
- degenerative neuromuscular disease
- prior or current diagnosis of bilateral or hemorrhagic stroke
- prior surgery to the head and neck region that would affect muscles involved in swallowing
- history of radiotherapy or chemotherapy to the head and neck
- patient unable to complete the exercise program
- taking medications that depress the central nervous system
- allergy to barium (used in videofluoroscopic swallowing assessment)
- currently pregnant.
Where it is running
- University of Wisconsin-Madison — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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