High Intensity Dysphagia Rehab for Acute Ischemic Stroke Patients
Primary Purpose
Dysphagia Following Cerebrovascular Accident
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
high intensity dysphagia therapy
Sponsored by
About this trial
This is an interventional treatment trial for Dysphagia Following Cerebrovascular Accident
Eligibility Criteria
Inclusion Criteria: Ages 18-99 Ischemic Stroke Identified to have acute dysphagia s/p ischemic stroke Able to follow 1-step commands for swallowing directions Exclusion Criteria: Younger than 18, older than 100 Hemorrhagic Stroke, Subarachnoid hemorrhage, subdural hematoma, epidural hematoma h/o dysphagia Advanced progressive neurological disease
Sites / Locations
- Johns Hopkins Bayview Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active Participants in high intensity dysphagia therapy
Arm Description
Participants with acute dysphagia who will receive high intensity dysphagia therapy during stay in inpatient rehab facility
Outcomes
Primary Outcome Measures
Number of participants with improved swallowing as assessed by the improved Penetration Aspiration Scale (PAS)
Measured with improved Penetration Aspiration Scale (PAS)
Number of participants with improved swallowing as assessed by the Functional Oral Intake Scale (FOIS)
Measured with the Functional Oral Intake Scale (FOIS)
Number of participants with perceived improvements in swallowing
Measured with improved EAT-10 Questionnaire Scores
Secondary Outcome Measures
Full Information
NCT ID
NCT05970406
First Posted
July 24, 2023
Last Updated
September 8, 2023
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT05970406
Brief Title
High Intensity Dysphagia Rehab for Acute Ischemic Stroke Patients
Official Title
Effects of High Intensity Dysphagia Rehabilitation on Adults With Dysphagia s/p Acute Ischemic Stroke in an Acute Rehab Facility
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia Following Cerebrovascular Accident
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Participants in high intensity dysphagia therapy
Arm Type
Experimental
Arm Description
Participants with acute dysphagia who will receive high intensity dysphagia therapy during stay in inpatient rehab facility
Intervention Type
Other
Intervention Name(s)
high intensity dysphagia therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of participants with improved swallowing as assessed by the improved Penetration Aspiration Scale (PAS)
Description
Measured with improved Penetration Aspiration Scale (PAS)
Time Frame
up to 6 weeks
Title
Number of participants with improved swallowing as assessed by the Functional Oral Intake Scale (FOIS)
Description
Measured with the Functional Oral Intake Scale (FOIS)
Time Frame
up to 6 weeks
Title
Number of participants with perceived improvements in swallowing
Description
Measured with improved EAT-10 Questionnaire Scores
Time Frame
up to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages 18-99
Ischemic Stroke
Identified to have acute dysphagia s/p ischemic stroke
Able to follow 1-step commands for swallowing directions
Exclusion Criteria:
Younger than 18, older than 100
Hemorrhagic Stroke, Subarachnoid hemorrhage, subdural hematoma, epidural hematoma
h/o dysphagia
Advanced progressive neurological disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie S Muhly, MS
Phone
410-925-7393
Email
jmuhly1@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alexa Taicher, MS
Phone
410-550-0225
Email
ataiche1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alba M Azola, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie S Muhly, MS
Phone
410-925-7393
Email
jmuhly1@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Alba M Azola, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
8209677
Citation
Buchholz DW. Dysphagia associated with neurological disorders. Acta Otorhinolaryngol Belg. 1994;48(2):143-55.
Results Reference
background
PubMed Identifier
7493505
Citation
Buchholz DW. Oropharyngeal dysphagia due to iatrogenic neurological dysfunction. Dysphagia. 1995 Fall;10(4):248-54. doi: 10.1007/BF00431417.
Results Reference
background
PubMed Identifier
8077779
Citation
Lugger KE. Dysphagia in the elderly stroke patient. J Neurosci Nurs. 1994 Apr;26(2):78-84. doi: 10.1097/01376517-199404000-00005.
Results Reference
background
PubMed Identifier
10971024
Citation
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.
Results Reference
background
PubMed Identifier
16269630
Citation
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.
Results Reference
background
PubMed Identifier
24977109
Citation
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.
Results Reference
background
PubMed Identifier
32140905
Citation
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.
Results Reference
background
PubMed Identifier
26711168
Citation
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.
Results Reference
background
PubMed Identifier
17457549
Citation
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.
Results Reference
background
PubMed Identifier
33880656
Citation
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.
Results Reference
background
PubMed Identifier
16084801
Citation
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.
Results Reference
background
PubMed Identifier
19140539
Citation
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.
Results Reference
background
PubMed Identifier
30804667
Citation
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.
Results Reference
background
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High Intensity Dysphagia Rehab for Acute Ischemic Stroke Patients
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