High Intensity Dysphagia Therapy for Stroke

Overseen By Alexa Taicher, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Hemorrhagic stroke, Neurological disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment High Intensity Dysphagia Rehab for stroke patients?

Research shows that intensive dysphagia rehabilitation can improve swallowing function in patients with neurogenic dysphagia, which includes those with stroke-related swallowing difficulties. Additionally, early rehabilitation for stroke patients with dysphagia has been shown to reduce the persistence of swallowing problems, indicating that targeted rehabilitation can be effective. ^{1 2 3 4 5}

How is High Intensity Dysphagia Rehab treatment different from other treatments for dysphagia after stroke?

High Intensity Dysphagia Rehab is unique because it involves a more intensive and frequent rehabilitation approach, focusing on individualized therapy sessions multiple times a day, which is different from traditional dysphagia treatments that often involve less frequent and less intense interventions. ^{1 3 6 7 8}

Research Team

Alba M Azola, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

Inclusion Criteria

You can understand and follow simple instructions for swallowing.

I have had an ischemic stroke.

I have sudden difficulty swallowing after a stroke.

Exclusion Criteria

I have had a bleeding stroke or brain bleed.

I have a history of difficulty swallowing.

My neurological condition is getting worse.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive high intensity dysphagia therapy with daily sessions including swallowing exercises and device-assisted training

6 weeks

Daily sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with a follow-up phone call

4-6 weeks post-discharge

1 follow-up call

Treatment Details

Interventions

• High Intensity Dysphagia Rehab

Trial Overview 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.

Participant Groups

Group I: Active Participants in high intensity dysphagia therapy Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

The Intensive Dysphagia Rehabilitation Approach Applied to Patients With Neurogenic Dysphagia: A Case Series Design Study. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Dysphagia in patients with brainstem stroke: incidence and outcome. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The individualized rehabilitation interventions for dysphagia: a multidisciplinary case control study of acute stroke patients. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Best Practice Recommendations for Stroke Patients with Dysphagia: A Delphi-Based Consensus Study of Experts in Turkey-Part II: Rehabilitation. [2022]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Dysphagia in patients with cerebral stroke during early inpatient rehabilitation]. [2016]

6. England pubmed.ncbi.nlm.nih.gov

Early and intensive rehabilitation predicts good functional outcomes in patients admitted to the stroke intensive care unit. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Dysphagia Management in Acute and Sub-acute Stroke. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Development and Implementation of a New Model of Care for Patients With Stroke, Acute Hospital Rehabilitation Intensive SErvices: Leveraging a Multidisciplinary Rehabilitation Team. [2023]