Effects of Oropharyngeal Strengthening on Dysphagia in Patients Post-stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Isometric Progressive Resistance Oropharyngeal Therapy; Compensatory approaches
Intervention type(s): Device; Behavioral
Intervention description(s): 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.
Other intervention name(s): SwallowStrong device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; Deglutition; Deglutition disorders; Resistance training