High Intensity Dysphagia Rehab for Acute Ischemic Stroke Patients

November 10, 2025 updated by: Johns Hopkins University

Effects of High Intensity Dysphagia Rehabilitation on Adults With Dysphagia s/p Acute Ischemic Stroke in an Acute Rehab Facility

The purpose of this study is to determine a standardized protocol for swallowing therapy and this protocol's effects on recovery after a stroke

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This study will include adults, aged 18-99, who are admitted to Johns Hopkins Bayview (JHBMC) Rehabilitation Unit following an acute ischemic stroke with a diagnosis of dysphagia, determined by instrumental assessment with a Video Fluoroscopic Swallowing Study (VFSS). All participants will be asked to complete an informed consent form prior to admission to the study. Initial objective assessment of swallowing with video fluoroscopic swallowing assessment will be completed within 72 hours of admission to the unit. Participants with PAS scores of greater than or equal to 3 and FOIS scores of less than or equal to 6 will be admitted to the study and asked to complete the Eating Assessment Tool (EAT-10) score sheets. Intensive swallowing interventions with Speech Language Pathologists will begin within 24 hours. Daily treatment will include two 30-minute sessions, 5-6 days a week which will include the evidence-based dysphagia exercises focusing on tongue resistance, head lift/chin tuck against resistance and expiratory muscle strength training tasks. Devices utilized will include the Iowa Oral Performance Instrument (IOPI), and the Positive Expiratory Pressure (PEP) Respironics device or the Expiratory Muscle Strength Training (EMST150) device. Each session will involve IOPI measurements of lingual strength with endurance tasks set at 60% and 75% max strength scores to be completed for total of 10 attempts at each level for isometric and isokinetic tasks; Expiratory muscle strength training with EMST150 or PEP Respironics (dependent on strength levels) will be set at 75% max resistance levels per training method, for 25 completions per session; Shaker or Chin Tuck Against Resistance (CTAR) using 4.5 inch standard rubber ball - determined by patient positioning restrictions or tolerance- will be completed with goals of isometric hold for 1 minute x3 attempts and isokinetic x10 x3 attempts each session. At least one session per day will include consumption of ice chips and/or food dependent on PAS levels. At least one additional VFSS will be completed prior to discharge from study, as is standard of care within the JHBMC Rehab Unit. Outcome measures will be assessed with pre and post PAS scores (comparing initial and final VFSS results), EAT 10 scores and FOIS scores as well as documented improvements in IOPI and EMST/PEP levels at two-week intervals and will continue throughout the acute comprehensive inpatient rehabilitation unit (ACIR) stay as indicated. A follow up phone call with each participant will occur between 4-6 weeks post discharge from the and be completed with EAT-10 and FOIS over phone by Speech Language Pathologists or the investigator.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Ages 18-99
  2. Ischemic Stroke
  3. Identified to have acute dysphagia s/p ischemic stroke
  4. Able to follow 1-step commands for swallowing directions

Exclusion Criteria:

  1. Younger than 18, older than 100
  2. Hemorrhagic Stroke, Subarachnoid hemorrhage, subdural hematoma, epidural hematoma
  3. h/o dysphagia
  4. Advanced progressive neurological disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Participants in high intensity dysphagia therapy
Participants with acute dysphagia who will receive high intensity dysphagia therapy during stay in inpatient rehab facility
Other: high intensity dysphagia therapy
Intensive swallowing interventions with Speech Language Pathologists to begin within 24 hours of video swallow study results. Daily treatment will include two 30-minute sessions, 5-6 days a week which will include the evidence-based dysphagia exercises focusing on tongue resistance, head lift/chin tuck against resistance and expiratory muscle strength training tasks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with improved swallowing as assessed by the improved Penetration Aspiration Scale (PAS)
Time Frame: up to 6 weeks
Measured with improved Penetration Aspiration Scale (PAS)
up to 6 weeks
Number of participants with improved swallowing as assessed by the Functional Oral Intake Scale (FOIS)
Time Frame: up to 6 weeks
Measured with the Functional Oral Intake Scale (FOIS)
up to 6 weeks
Number of participants with perceived improvements in swallowing
Time Frame: up to 6 weeks
Measured with improved EAT-10 Questionnaire Scores
up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Alba M Azola, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2023

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

July 24, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

November 12, 2025

Last Update Submitted That Met QC Criteria

November 10, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00335053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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