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NCT02322411 · ClinicalTrials.gov registry record · NA

Effects of Oropharyngeal Strengthening on Dysphagia in Patients Post-stroke

A NA study of Stroke, sponsored by University of Wisconsin, Madison.

Completed
Registry status
NA
Development phase
30
Enrollment target
1
Study location

NCT02322411 is a NA study of Stroke that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 30 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02322411, a NA study of Stroke, has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
NA
Development phase
30 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • DEVICE Isometric Progressive Resistance Oropharyngeal Therapy
  • BEHAVIORAL Compensatory approaches

Study Locations (1)

Wisconsin

  • University of Wisconsin-Madison - Madison

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2015-01
Est. Completion 2017-10-19
Phase NA

Sponsor

University of Wisconsin, Madison

1,039 total trials

What the Registry Record Tells You About NCT02322411

The ClinicalTrials.gov registry entry for NCT02322411 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which Isometric Progressive Resistance Oropharyngeal Therapy is the first listed.

NCT02322411 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.

Frequently Asked Questions

What is clinical trial NCT02322411 about?

NCT02322411 is a clinical study titled "Effects of Oropharyngeal Strengthening on Dysphagia in Patients Post-stroke". 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. ...

What is the current status of trial NCT02322411?

This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2015-01. Estimated completion is 2017-10-19.

What conditions does trial NCT02322411 study?

This clinical trial studies the following conditions: Stroke.

What interventions are being tested in trial NCT02322411?

The interventions under investigation include: Isometric Progressive Resistance Oropharyngeal Therapy (DEVICE), Compensatory approaches (BEHAVIORAL).

Who is sponsoring clinical trial NCT02322411?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02322411 being conducted?

This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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