High Intensity Dysphagia Rehab for Acute Ischemic Stroke Patients

Not Applicable

• Conditions: Dysphagia Following Cerebrovascular Accident

• Registration Number: NCT05970406
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-07-24
• Study First Posted: 2023-08-01
• Study Start: 2023-11-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-15
• Primary Completion: 2026-11-30
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States