K01 Impacts of Lingual Endurance Exercise

Study Overview
=================
Brief Summary
-----------------
Swallowing impairments (dysphagia) frequently occur after stroke and have devastating consequences on overall health and quality of life, and long-term deficits in swallow function also increase risk of morbidity (e.g. depression) and mortality (i.e. aspiration pneumonia). As such, rehabilitation of swallow function to improve safety and efficiency of swallowing is essential in this population. This study aims to: 1) Provide preliminary data to evaluate the effect of a novel lingual endurance exercise on swallow function in individuals with post-stroke dysphagia; and 2) Collect preliminary data regarding changes in white matter tract diffusion and cortical thickness and from MRI data to better understand effects of lingual exercise training on neuroplasticity.

Detailed Description
-----------------
This pilot trial will evaluate the effect of lingual endurance exercise (vs sham exercise) on recovery of swallow function after stroke. The Primary Aim of this study is to evaluate effects of lingual endurance exercise vs sham on swallow function in individuals with post-stroke dysphagia. The investigators hypothesize that lingual endurance training will result in greater improvement in measures of oral swallow physiology as compared to sham. Regardless of outcome, this dataset will provide innovative and highly novel information regarding the relationship between lingual function, swallowing impairments, and cortical representation of dysphagia in a post stroke population. These pilot data will be essential in providing sufficient power for designing an R01 Phase II intervention trial to investigate how to maximize gains with timing and intensity of therapy delivery to better recover swallow function after stroke.

Official Title
-----------------
Impact of Lingual Endurance Exercise on Rehabilitation of Swallowing Impairments After Ischemic Stroke

Conditions
-----------------
Dysphagia, Dysphagia, Oropharyngeal, Ischemic Stroke

Intervention / Treatment
-----------------
* Behavioral: Isotonic Endurance Exercise
* Behavioral: Sham Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) 3-6 months since most recent diagnosis of ischemic, non-hemorrhagic stroke occurring in areas involving anterior or posterior circulation and affecting underlying cortical or subcortical structures (including brainstem) 2) able to tolerate some oral intake required for assessment of swallowing function via modified barium swallow study (MBSS) 4) able to follow 2-step commands. 3) MBSImP Oral Total (OT) score >10 on Modified Barium Swallow Study (MBSS) Exclusion Criteria: 1) ≤18 years of age 2) history of dysphagia prior to or after the stroke caused by any of the following conditions: gastrointestinal disease, traumatic brain injury, head and neck cancer, surgery involving the pharynx or larynx 3) history of other neurological disease (i.e. multiple sclerosis, ALS, Parkinsons, dementia). 4) Any history of dysphagia from prior stroke will be exclusionary.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Sham Controlled
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lingual Endurance Exercise<br>The experimental exercise group will participate in 3 training sessions per day for 8 weeks. Endurance exercise will include completing isotonic endurance repetitions 3 times a day. Number of repetitions per session will be determined during baseline testing for each participant. | Behavioral: Isotonic Endurance Exercise<br>* Pressing tongue against a pressure sensor at the set number of repetitions per session (individualized per participant) 3 times per day<br>|
| Sham Comparator: Sham Exercise<br>The sham control group will be instructed to press the lingual sensor 30 times at a very low-pressure threshold (1-5 kPa), which will be monitored weekly via device output sent to the study team to avoid use of excessive force that would qualify as exercise (>5 kPa). | Behavioral: Sham Exercise<br>* Pressing tongue against pressure sensor at a low threshold (1-5kPa) 30x/day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Barium Swallow Study Impairment Profile Oral Total (MBSImP OT Score) | MBSImP is a validated, standardized tool for assessing oral, pharyngeal, and esophageal swallowing function. We will be using change in OT score (sum of components 1-6) as our primary outcome measure. | Change from Baseline (at the end of 8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalized Residue Ratio Scale (NRRS) | Measure of swallow efficiency by calculating the amount of residue remaining after a swallow | Change from Baseline (at the end of 8 weeks) | 
| Penetration Aspiration Scale (PAS) Scores | 8-point rating scale that is used to capture both degree and sensation of penetration and aspiration | Change from Baseline (at the end of 8 weeks) | 
| Adherence | number of repetitions attempted/total number of repetitions prescribed | At the end of 8 weeks |