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High Intensity Dysphagia Rehab for Acute Ischemic Stroke Patients

NCT ID: NCT05970406

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2027-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Dysphagia Following Cerebrovascular Accident

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active Participants in high intensity dysphagia therapy

Participants with acute dysphagia who will receive high intensity dysphagia therapy during stay in inpatient rehab facility

Group Type EXPERIMENTAL

high intensity dysphagia therapy

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alba M Azola, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.

Reference Type BACKGROUND
PMID: 16269630 (View on PubMed)

Gonzalez-Fernandez M, Ottenstein L, Atanelov L, Christian AB. Dysphagia after Stroke: an Overview. Curr Phys Med Rehabil Rep. 2013 Sep;1(3):187-196. doi: 10.1007/s40141-013-0017-y.

Reference Type BACKGROUND
PMID: 24977109 (View on PubMed)

Krekeler BN, Rowe LM, Connor NP. Dose in Exercise-Based Dysphagia Therapies: A Scoping Review. Dysphagia. 2021 Feb;36(1):1-32. doi: 10.1007/s00455-020-10104-3. Epub 2020 Mar 5.

Reference Type BACKGROUND
PMID: 32140905 (View on PubMed)

Alkhuwaiter M, Davidson K, Hopkins-Rossabi T, Martin-Harris B. Scoring the Penetration-Aspiration Scale (PAS) in Two Conditions: A Reliability Study. Dysphagia. 2022 Apr;37(2):407-416. doi: 10.1007/s00455-021-10292-6. Epub 2021 Apr 21.

Reference Type BACKGROUND
PMID: 33880656 (View on PubMed)

Crary MA, Mann GD, Groher ME. Initial psychometric assessment of a functional oral intake scale for dysphagia in stroke patients. Arch Phys Med Rehabil. 2005 Aug;86(8):1516-20. doi: 10.1016/j.apmr.2004.11.049.

Reference Type BACKGROUND
PMID: 16084801 (View on PubMed)

Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210.

Reference Type BACKGROUND
PMID: 19140539 (View on PubMed)

Balou M, Herzberg EG, Kamelhar D, Molfenter SM. An intensive swallowing exercise protocol for improving swallowing physiology in older adults with radiographically confirmed dysphagia. Clin Interv Aging. 2019 Feb 11;14:283-288. doi: 10.2147/CIA.S194723. eCollection 2019.

Reference Type BACKGROUND
PMID: 30804667 (View on PubMed)

Malandraki GA, Rajappa A, Kantarcigil C, Wagner E, Ivey C, Youse K. The Intensive Dysphagia Rehabilitation Approach Applied to Patients With Neurogenic Dysphagia: A Case Series Design Study. Arch Phys Med Rehabil. 2016 Apr;97(4):567-574. doi: 10.1016/j.apmr.2015.11.019. Epub 2015 Dec 19.

Reference Type BACKGROUND
PMID: 26711168 (View on PubMed)

Burkhead LM, Sapienza CM, Rosenbek JC. Strength-training exercise in dysphagia rehabilitation: principles, procedures, and directions for future research. Dysphagia. 2007 Jul;22(3):251-65. doi: 10.1007/s00455-006-9074-z. Epub 2007 Apr 25.

Reference Type BACKGROUND
PMID: 17457549 (View on PubMed)

Mann G, Hankey GJ, Cameron D. Swallowing disorders following acute stroke: prevalence and diagnostic accuracy. Cerebrovasc Dis. 2000 Sep-Oct;10(5):380-6. doi: 10.1159/000016094.

Reference Type BACKGROUND
PMID: 10971024 (View on PubMed)

Buchholz DW. Dysphagia associated with neurological disorders. Acta Otorhinolaryngol Belg. 1994;48(2):143-55.

Reference Type BACKGROUND
PMID: 8209677 (View on PubMed)

Buchholz DW. Oropharyngeal dysphagia due to iatrogenic neurological dysfunction. Dysphagia. 1995 Fall;10(4):248-54. doi: 10.1007/BF00431417.

Reference Type BACKGROUND
PMID: 7493505 (View on PubMed)

Lugger KE. Dysphagia in the elderly stroke patient. J Neurosci Nurs. 1994 Apr;26(2):78-84. doi: 10.1097/01376517-199404000-00005.

Reference Type BACKGROUND
PMID: 8077779 (View on PubMed)

Other Identifiers

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IRB00335053

Identifier Type: -

Identifier Source: org_study_id