High Intensity Dysphagia Rehab for Acute Ischemic Stroke Patients

NCT05970406 | Enrolling By Invitation

• 1 other identifier: IRB00335053
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dysphagia Following Cerebrovascular Accident

Outcome Measures

Primary Outcomes (3)

• Number of participants with improved swallowing as assessed by the improved Penetration Aspiration Scale (PAS)

  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)

  Measured with the Functional Oral Intake Scale (FOIS)

  up to 6 weeks

• Number of participants with perceived improvements in swallowing

  Measured with improved EAT-10 Questionnaire Scores

  up to 6 weeks

Study Arms (1)

Active Participants in high intensity dysphagia therapy

EXPERIMENTAL

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

Other: high intensity dysphagia therapy

Interventions

high intensity dysphagia therapy 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

Active Participants in high intensity dysphagia therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Younger than 18, older than 100
• Hemorrhagic Stroke, Subarachnoid hemorrhage, subdural hematoma, epidural hematoma
• h/o dysphagia
• Advanced progressive neurological disease

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (13)

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

  PMID: 8209677 BACKGROUND

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

  PMID: 7493505 BACKGROUND

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

  PMID: 8077779 BACKGROUND

• 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.

  PMID: 10971024 BACKGROUND

• 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.

  PMID: 16269630 BACKGROUND

• 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.

  PMID: 24977109 BACKGROUND

• 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.

  PMID: 32140905 BACKGROUND

• 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.

  PMID: 26711168 BACKGROUND

• 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.

  PMID: 17457549 BACKGROUND

• 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.

  PMID: 33880656 BACKGROUND

• 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.

  PMID: 16084801 BACKGROUND

• 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.

  PMID: 19140539 BACKGROUND

• 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.

  PMID: 30804667 BACKGROUND

Study Officials

• Alba M Azola, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: November 30, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)