Effects of Oropharyngeal Strengthening on Dysphagia in Patients Post-stroke

NCT02322411 | Completed Results FDA Device

• 3 other identifiers: 2014-0747A534255SMPH/MEDICINE/GER-AD DEV
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Stroke; Deglutition; Deglutition disorders; Resistance training

Outcome Measures

Primary Outcomes (1)

• 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

  After 8 weeks and 12 weeks

Secondary Outcomes (6)

• Percent Residue

  baseline, 8 and 12 weeks

• Swallowing-related Pressures (Videofluoroscopic Swallow Study)

  After 8 and 12 weeks

• Dysphagia-related Quality of Life Scores (SWAL-QOL)

  After 8 weeks and 12 weeks

• Functional Oral Intake Scale (FOIS) Scores

  After 8 weeks and 12 weeks

• Pneumonia Diagnoses (Number of Pneumonia Diagnoses)

  up to 9 months

Study Arms (2)

Compensatory

ACTIVE COMPARATOR

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

I-PRO + compensatory

EXPERIMENTAL

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

Interventions

Isometric Progressive Resistance Oropharyngeal Therapy DEVICE

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

I-PRO + compensatory

Compensatory approaches BEHAVIORAL

Compensatory; I-PRO + compensatory

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53562, United States

Location

Related Publications (1)

• Krekeler BN, Yee J, Kurosu A, Osman F, Pena-Chavez R, Leverson G, Young B, Sattin J, Knigge M, Thibeault S, Rogus-Pulia N. Effects of Device-Facilitated Lingual Strengthening Therapy on Dysphagia Related Outcomes in Patients Post-Stroke: A Randomized Controlled Trial. Dysphagia. 2023 Dec;38(6):1551-1567. doi: 10.1007/s00455-023-10583-0. Epub 2023 May 17.

  PMID: 37195518 DERIVED

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Dr. Nicole Pulia
• Organization: University of Wisconsin - Madison

npulia@wisc.edu

6082561901

Study Officials

• Nicole Pulia, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 23, 2014
• Study Start: January 1, 2015
• Primary Completion: October 19, 2017
• Study Completion: October 19, 2017
• Last Updated: July 15, 2020
• Results First Posted: June 19, 2019

Record last verified: 2020-07

Locations

US (1)