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Behavioural Intervention

High Intensity Dysphagia Therapy for Stroke

N/A
Waitlist Available
Led By Alba M Azola, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ischemic Stroke
Identified to have acute dysphagia s/p ischemic stroke
Must not have
Hemorrhagic Stroke, Subarachnoid hemorrhage, subdural hematoma, epidural hematoma
History of dysphagia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a standard therapy to help stroke survivors recover their swallowing ability.

Who is the study for?
This trial is for adults aged 18-99 who have had an ischemic stroke and are experiencing acute swallowing difficulties (dysphagia) as a result. Participants must be able to follow simple instructions for swallowing therapy. It's not suitable for those under 18 or over 100, with other types of strokes, previous dysphagia, or advanced progressive neurological diseases.
What is being tested?
The study is testing high intensity dysphagia therapy to establish a standardized treatment protocol that could improve recovery from swallowing disorders following an ischemic stroke.
What are the potential side effects?
While the specific side effects are not detailed here, high intensity therapies can sometimes lead to fatigue or discomfort in the affected muscles due to the rigorous nature of exercises involved.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had an ischemic stroke.
Select...
I have sudden difficulty swallowing after a stroke.
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I am between 18 and 99 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a bleeding stroke or brain bleed.
Select...
I have a history of difficulty swallowing.
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My neurological condition is getting worse.
Select...
I am between 18 and 100 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with improved swallowing as assessed by the Functional Oral Intake Scale (FOIS)
Number of participants with improved swallowing as assessed by the improved Penetration Aspiration Scale (PAS)
Number of participants with perceived improvements in swallowing

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Active Participants in high intensity dysphagia therapyExperimental Treatment1 Intervention
Participants with acute dysphagia who will receive high intensity dysphagia therapy during stay in inpatient rehab facility

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,321 Previous Clinical Trials
14,873,878 Total Patients Enrolled
1 Trials studying Dysphagia
Alba M Azola, MDPrincipal InvestigatorJohns Hopkins University

Media Library

High Intensity Dysphagia Rehab (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05970406 — N/A
Dysphagia Research Study Groups: Active Participants in high intensity dysphagia therapy
Dysphagia Clinical Trial 2023: High Intensity Dysphagia Rehab Highlights & Side Effects. Trial Name: NCT05970406 — N/A
High Intensity Dysphagia Rehab (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05970406 — N/A
~40 spots leftby Nov 2026
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