An interventional study of Isometric Progressive Resistance Oropharyngeal Therapy and Compensatory approaches in Stroke, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 21 Years to 95 Years. Per ClinicalTrials.gov, last updated 2020-07-15.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Treatment
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.
Dysphagia is estimated to occur in up to 76% of acute stroke patients1,2 and by 2030 the prevalence of stroke is estimated to rise by 21%.3 Serious health complications may result from the presence of dysphagia following stroke, including the development of aspiration pneumonia, malnutrition, and mortality.4-6 Developing pneumonia post-stroke results in a significantly increased relative risk (2.99) of death within 30 days of hospital discharge.1 Compensatory approaches to intervention, including postures or diet modification, are commonly used but do not enact lasting change in swallowing function. Early and intensive therapy approaches are suggested for attainment of optimal swallowing outcomes.7 The tongue is the primary propulsive force for movement of the bolus through the oral cavity and pharynx and into the cervical esophagus during swallowing. Patients post-stroke demonstrate lower than normal maximum isometric lingual pressures, measured as pressures produced when the tongue is pushed as hard as possible against the palate.2 Progressive resistance training for the tongue and related oropharyngeal musculature has been shown to improve swallow physiology and quality of life for patients post-stroke.8 Previous studies have examined Isometric Progressive Resistance Oropharyngeal (I-PRO) therapy facilitated by the Iowa Oral Pressure Instrument (IOPI) for lingual strengthening. The recently developed SwallowSTRONG® device consists of a customized, adjustable mouthpiece that provides pressure readings from embedded sensors allowing for consistent tongue placement, immediate knowledge of performance levels, and automatic calculation of therapeutic strengthening targets. Results from a federally-funded Department of Veterans Affairs Clinical Demonstration Program that employed use of device-facilitated (DF) I-PRO therapy showed improved swallowing-related outcomes in a group of patients with oropharyngeal dysphagia resulting from a variety of medical etiologies.9 The effects of this therapy approach on various aspects of swallowing function and health status in a group of post-stroke patients have yet to be examined. In addition, ideal treatment duration for use with stroke patients is unknown.
The long term goal of this work is to develop more effective, evidence-based treatments that improve overall health status related to swallowing-specific changes for patients with dysphagia. The preliminary group data generated will provide the basis for a line of work dedicated to determination of effective treatments for patients post-stroke.
Specific Aims include: 1) determine differences in swallowing physiology and bolus flow measures a) between a group of unilateral ischemic stroke subjects undergoing DF I-PRO therapy and a control group and b) between two durations of treatment (8 and 12 weeks); 2) examine changes in level of oral intake and swallowing quality of life in post-stroke patients undergoing I-PRO therapy as compared to a control group and as they relate to treatment duration response at 8 weeks and 12 weeks; and 3) 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.
In order to address these aims, thirty patients who have suffered unilateral ischemic stroke will be recruited. Subjects will be randomized to receive either 1) 12 weeks of DF I-PRO therapy plus compensatory treatment or 2) compensatory treatment only. Assessments will take place at baseline, 8 and 12 weeks. The primary outcome measure will be changes in maximum isometric tongue pressures. Details regarding specific outcomes most influenced by this approach and dose response effects will inform the clinical practice of Speech-Language Pathologists and facilitate strengthening regimens to become more standard for the treatment of stroke related dysphagia.
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This study's enrollment of 30 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
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Exclusion Criteria:
This group will receive standard swallowing intervention, which is identified by the SLP as appropriate to treat the patient's dysphagia and is common clinical practice. Their therapy may include: 1) modifying their foods and fluids; 2) changing their posture when they eat or drink; or 3) having them eat more slowly or in a quiet environment to make swallowing easier and safer. These compensatory approaches will ensure safety while swallowing foods and fluids. Range of motion, vocal exercises, and other oromotor exercises, such as the Shaker Exercise, as well as any other potential strengthening regimens for swallowing or speech will be delayed until subjects have completed participation.
Behavioral: Compensatory approaches
The Device-Facilitated Isometric Progressive Resistance Oropharyngeal (D-F I-PRO) intervention will be completed using the SwallowSTRONG® device. Tongue press exercises consist of pressing the tongue against the sensors located along the hard palate. Isometric exercises will focus on the anterior and posterior sensor. Subjects will take the SwallowStrong® device home with them and will complete 20 repetitions of the exercise (10 repetitions at the front sensor; 10 repetitions at the back sensor), three times per day on three days per week for twelve weeks.
Device: Isometric Progressive Resistance Oropharyngeal Therapy · Behavioral: Compensatory approaches
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.
Also known as: SwallowStrong device
Lingual Pressures (Changes in the One Repetition Maximum Isometric Lingual Pressures)
Changes in the one repetition maximum isometric lingual pressures measured at the front and back sensors of the device
Time frame: After 8 weeks and 12 weeks
Percent Residue
Measurement of Residue
Time frame: baseline, 8 and 12 weeks
Swallowing-related Pressures (Videofluoroscopic Swallow Study)
Pressures will be measured while the subject is swallowing during the videofluoroscopic swallow study
Time frame: After 8 and 12 weeks
Dysphagia-related Quality of Life Scores (SWAL-QOL)
A quality of life questionnaire related to swallowing. The scores range from 0-100, and a higher score indicates a higher quality of life related to swallowing.
Time frame: After 8 weeks and 12 weeks
Functional Oral Intake Scale (FOIS) Scores
FOIS scores reflect level of nutritional intake. Scores range from 1 to 7, with 1 being nothing by mouth and with 7 indicating a diet with no restrictions. Qualitative assessment via interview. Range of final scores is between 1 and 7. Average scores of each arm reported at 8 and 12 weeks.
Time frame: After 8 weeks and 12 weeks
Pneumonia Diagnoses (Number of Pneumonia Diagnoses)
The number of pneumonia diagnoses within 9 months following completion of the program will be compared to the same pre-enrollment period.
Time frame: up to 9 months
Hospital Admissions (Number of Hospital Admissions and Readmissions)
The number of hospital admissions and readmissions within 9 months following completion of the program will be compared to the same pre-enrollment period.
Time frame: up to 9 months
| Milestone | Compensatory | I-PRO + Compensatory |
|---|---|---|
| Started | 14 | 16 |
| Randomized | 14 | 16 |
| All baseline measures analyzed | 13 | 16 |
| Completed | 9 | 9 |
| Not completed | 5 | 7 |
| Withdrew: Lost to follow-up | 4 | 7 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Changes in the one repetition maximum isometric lingual pressures measured at the front and back sensors of the device
| hPa | Compensatory | I-PRO + Compensatory |
|---|---|---|
| Front Lingual Pressure at 8 weeks | 83.3 ± 71.9 | 239.6 ± 123.0 |
| Front Lingual Pressure at 12 weeks | 129.8 ± 108.0 | 386.3 ± 229.9 |
| Back Lingual Pressure at 8 weeks | 31.5 ± 52.6 | 127.6 ± 158.9 |
| Back Lingual Pressure at 12 weeks | 50.05 ± 55.6 | 131.4 ± 118.9 |
Measurement of Residue
| Percent Residue | Compensatory | I-PRO + Compensatory |
|---|---|---|
| Baseline Total Residue | 9.12 ± 8.39 | 10.20 ± 8.54 |
| 8-Week Total Residue | 7.14 ± 5.22 | 7.12 ± 4.67 |
| 12-Week Total Residue | 5.65 ± 3.27 | 7.55 ± 4.27 |
Pressures will be measured while the subject is swallowing during the videofluoroscopic swallow study
No measurements were reported for this outcome.
A quality of life questionnaire related to swallowing. The scores range from 0-100, and a higher score indicates a higher quality of life related to swallowing.
| score on a scale | Compensatory | I-PRO + Compensatory |
|---|---|---|
| SWAL-QOL score at 8 weeks | 86.0 ± 14.6 | 85.5 ± 8.5 |
| SWAL-QOL score at 12 weeks | 88.9 ± 5.0 | 86.3 ± 8.1 |
FOIS scores reflect level of nutritional intake. Scores range from 1 to 7, with 1 being nothing by mouth and with 7 indicating a diet with no restrictions. Qualitative assessment via interview. Range of final scores is between 1 and 7. Average scores of each arm reported at 8 and 12 weeks.
| score on a scale | Compensatory | I-PRO + Compensatory |
|---|---|---|
| FOIS score at 8 weeks | 5.6 ± 1.9 | 6.8 ± 0.4 |
| FOIS score at 12 weeks | 5.8 ± 1.2 | 6.9 ± 0.4 |
The number of pneumonia diagnoses within 9 months following completion of the program will be compared to the same pre-enrollment period.
| incidences of pneumonia | Compensatory | I-PRO + Compensatory |
|---|---|---|
| Pneumonia Diagnoses (Number of Pneumonia Diagnoses) | 0 | 0 |
The number of hospital admissions and readmissions within 9 months following completion of the program will be compared to the same pre-enrollment period.
| hospital admissions | Compensatory | I-PRO + Compensatory |
|---|---|---|
| Admissions pre-enrollment | 1 | 0 |
| Admission post-enrollment | 0 | 0 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Compensatory | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| I-PRO + Compensatory | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Age, Continuous(years) | Compensatory | I-PRO + Compensatory | Total |
|---|---|---|---|
| Mean | 73.4 ± 15.5 | 68.9 ± 12.0 | 70.9 ± 13.6 |
| Sex: Female, Male(Participants) | Compensatory | I-PRO + Compensatory | Total |
|---|---|---|---|
| Female | 3 | 5 | 8 |
| Male | 10 | 11 | 21 |
| Race (NIH/OMB)(Participants) | Compensatory | I-PRO + Compensatory | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 13 | 16 | 29 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Compensatory | I-PRO + Compensatory | Total |
|---|---|---|---|
| United States | 13 | 16 | 29 |
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University of Wisconsin, Madison