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Lingual Exercises for Post-Stroke Swallowing Disorders

N/A

Waitlist Available

Led By Brittany Krekeler, PhD

Research Sponsored by University of Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline

Awards & highlights

Study Summary

This trial will enroll 15 participants in each of three exercise conditions in order to study the feasibility and efficacy of lingual endurance training to improve aspects of swallowing for those with persistent dysphagia after ischemic stroke. The three groups are: 1) lingual endurance training, 2) lingual endurance training + transference exercise, and 3) no exercise. The primary outcome measures are patient adherence and improvement on videofluoroscopic assessment of swallowing function. Secondary outcome measures include oropharyngeal residue, airway invasion, and patient reported swallowing quality of life.

Who is the study for?

This trial is for English-speaking individuals who can follow commands and have had a first-time ischemic stroke at least 3 months ago, leading to swallowing difficulties. They must be able to eat orally to some extent for assessment and not have had dysphagia from other causes like gastrointestinal diseases or brain injuries.Check my eligibility

What is being tested?

The study tests two exercises: Lingual Endurance Exercise alone, and combined with Transference Exercise. It aims to see if these exercises are doable, improve swallowing function, oral intake, airway protection, and life quality in those with post-stroke dysphagia.See study design

What are the potential side effects?

Since the interventions involve physical exercises targeted at improving tongue strength and swallowing ability rather than drugs or invasive procedures, significant side effects are not anticipated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at 8 weeks (study completion)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at 8 weeks (study completion)

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 8 weeks (study completion) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence

Change from Baseline Eating Assessment Tool (EAT-10) Score

Change from Baseline Modified Barium Swallowing Impairment Profile (MBSImP) Oral Total Score

+1 more

Secondary outcome measures

Change from Baseline Functional Oral Intake Scale (FOIS) Score

Change from Baseline Worst Penetration Aspiration Scale (PAS) Score

Change from Baseline in Normalized Residue Ratio Rating (NRRS)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Lingual Endurance Training Only (Group 1)Experimental Treatment1 Intervention

Intervention group 1 will complete lingual endurance training only.

Group II: Lingual Endurance Training + Transference Exercise (Group 2)Experimental Treatment2 Interventions

Intervention Group 2 will complete lingual endurance exercise plus a transference exercise.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor

428 Previous Clinical Trials

634,367 Total Patients Enrolled

15 Trials studying Ischemic Stroke

12,646 Patients Enrolled for Ischemic Stroke

Brittany Krekeler, PhDPrincipal InvestigatorUniversity of Cincinnati, Department of Otolaryngology-Head and Neck Surgery

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the quota for participants in this experiment?

"Affirmative, according to clinicaltrials.gov this medical trial was first announced on August 2nd 2022 and is still in need of participants. There are 30 spots available at a single site for potential enrollees."

Answered by AI

What objectives has this research endeavor set out to achieve?

"This 8-week clinical trial will measure the effectiveness of adherence to a given intervention. Additionally, researchers are observing changes in patient responses as they relate to Worst Penetration Aspiration Scale (PAS) Score, Swallowing Quality of Life Questionnaire (SWAL-QoL), and Functional Oral Intake Scale (FOIS) Score. The best score for each metric is respectively 1, 0, and 7; while the worst score is 8, 100, and 1."

Answered by AI

Does this experiment have any open slots for participants?

"Per the information on clinicaltrials.gov, this research project is actively recruiting participants. It was made public on August 2nd 2022 and its content has been recently refreshed on August 30th 2022."

Answered by AI

Recent research and studies

Annals of Otology, Rhinology & LaryngologyJournal

Adjunctive Neuromuscular Electrical Stimulation for Treatment-refractory Dysphagia

Carnaby-Mann, Giselle D., and Michael A. Crary. 2008. “Adjunctive Neuromuscular Electrical Stimulation for Treatment-refractory Dysphagia”. Annals of Otology, Rhinology & Laryngology. SAGE Publications. doi:10.1177/000348940811700407.

DysphagiaJournal

Differentiation of Normal and Abnormal Airway Protection During Swallowing Using the Penetration–aspiration Scale

Robbins, JoAnne, James Coyle, Jay Rosenbek, Ellen Roecker, and Jennifer Wood. 1999. “Differentiation of Normal and Abnormal Airway Protection During Swallowing Using the Penetration–aspiration Scale”. Dysphagia. Springer Science and Business Media LLC. doi:10.1007/pl00009610.

Plos OneJournal

Dysphagia in Acute Stroke: Incidence, Burden and Impact on Clinical Outcome

Arnold, Marcel, Kai Liesirova, Anne Broeg-Morvay, Julia Meisterernst, Markus Schlager, Marie-Luise Mono, Marwan El-Koussy, Georg Kägi, Simon Jung, and Hakan Sarikaya. 2016. “Dysphagia in Acute Stroke: Incidence, Burden and Impact on Clinical Outcome”. Edited by Hooman Kamel. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0148424.

Alimentary Pharmacology & TherapeuticsJournal