N/A
N=30
Effects of Oropharyngeal Strengthening on Dysphagia in Patients Post-stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02322411 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Lingual Pressures (Changes in the One Repetition Maximum Isometric Lingual Pressures) — 83.3; 239.6; 129.8; 386.3 hPa
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Isometric Progressive Resistance Oropharyngeal Therapy (Device); Compensatory approaches (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lingual Pressures (Changes in the One Repetition Maximum Isometric Lingual Pressures) |
83.3; 239.6; 129.8; 386.3; 31.5; 127.6 | — |
| SECONDARY Percent Residue |
9.12; 10.20; 7.14; 7.12; 5.65; 7.55 | — |
| SECONDARY Swallowing-related Pressures (Videofluoroscopic Swallow Study) |
— | — |
| SECONDARY Dysphagia-related Quality of Life Scores (SWAL-QOL) |
86.0; 85.5; 88.9; 86.3 | — |
| SECONDARY Functional Oral Intake Scale (FOIS) Scores |
5.6; 6.8; 5.8; 6.9 | — |
| SECONDARY Pneumonia Diagnoses (Number of Pneumonia Diagnoses) |
0; 0 | — |
| SECONDARY Hospital Admissions (Number of Hospital Admissions and Readmissions) |
1; 0; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02322411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.