Lingual Exercises for Post-Stroke Swallowing Disorders

Recruiting in Palo Alto (17 mi)

Overseen byBrittany Krekeler, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Cincinnati

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will enroll 15 participants in each exercise condition (groups described below). Aim 1: Determine feasibility of lingual endurance training for individuals with persistent dysphagia after ischemic stroke. Primary outcome measures: patient adherence (# of attempted repetitions/# prescribed repetitions) and dose delivery (# of repetitions meeting goal/# prescribed repetitions). Aim 2: Determine efficacy of lingual endurance training on improving critical aspects of oropharyngeal swallowing (physiologic impairments, clearance of oropharyngeal residue, airway protection), functional oral intake, and patient reported swallowing quality of life in individuals with persistent dysphagia after ischemic stroke. Primary outcome measures: improvement on videofluoroscopic assessment of swallowing function using the gold standard Modified Barium Swallowing Impairment Profile (MBSImP) Overall Impairment (OI) score and Functional Oral Intake Scale (FOIS) score. Secondary outcome measures: oropharyngeal residue - Normalized Residue Ratio Scale (NRRS); airway invasion - Penetration Aspiration Scale (PAS). Patient reported outcome measures: EAT-10 (Eating Assessment Tool) and the Swallowing Quality of Life Questionnaire (SWAL-QoL). Aim 3: Determine if lingual endurance training + transference exercise (Exercise Group #2) results in better transference of exercise effects to the aforementioned outcomes of swallow safety and efficiency (in Aim2).

Research Team

Brittany Krekeler, PhD

Principal Investigator

University of Cincinnati, Department of Otolaryngology-Head and Neck Surgery

Eligibility Criteria

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.

Inclusion Criteria

It's been over 3 months since my first stroke, which was not caused by bleeding.

You need to have a score of one or more for any leftover food or liquid in your mouth or throat on the MBSImP test.

I can understand and follow 2-step commands.

See 2 more

Exclusion Criteria

I have a history of jaw joint problems or epilepsy.

Pregnant women

I have had swallowing difficulties due to a GI condition, brain injury, cancer, or surgery on my throat.

See 1 more

Treatment Details

Interventions

Lingual Endurance Exercise (Behavioural Intervention)
Lingual Endurance + Transference Exercise (Behavioural Intervention)

Trial OverviewThe 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.

Participant Groups

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.