K01 Impacts of Lingual Endurance Exercise
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lingual Endurance Exercise 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
Pressing tongue against a pressure sensor at the set number of repetitions per session (individualized per participant) 3 times per day
|
| Sham Comparator: Sham Exercise 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
Pressing tongue against pressure sensor at a low threshold (1-5kPa) 30x/day
|
Outcome Measures
Primary Outcome Measures
- Modified Barium Swallow Study Impairment Profile Oral Total (MBSImP OT Score) [Change from Baseline (at the end of 8 weeks)]
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.
Secondary Outcome Measures
- Normalized Residue Ratio Scale (NRRS) [Change from Baseline (at the end of 8 weeks)]
Measure of swallow efficiency by calculating the amount of residue remaining after a swallow
- Penetration Aspiration Scale (PAS) Scores [Change from Baseline (at the end of 8 weeks)]
8-point rating scale that is used to capture both degree and sensation of penetration and aspiration
- Adherence [At the end of 8 weeks]
number of repetitions attempted/total number of repetitions prescribed
Other Outcome Measures
- Change in fractional anisotropy (FA) [Change from Baseline (at the end of 8 weeks)]
Diffusion Tensor Imaging (DTI) has been the most common analysis framework that is used to analyze the signal from diffusion MRI (dMRI) to gather information about the properties of the underlying white matter.
- Change in cortical thickness [Change from Baseline (at the end of 8 weeks)]
Diffusion Tensor Imaging (DTI) has been the most common analysis framework that is used to analyze the signal from diffusion MRI (dMRI) to gather information about the properties of the underlying white matter.
Eligibility Criteria
Criteria
Inclusion Criteria:
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- 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)
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- 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.
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- MBSImP Oral Total (OT) score >10 on Modified Barium Swallow Study (MBSS)
Exclusion Criteria:
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- ≤18 years of age
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- 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
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- history of other neurological disease (i.e. multiple sclerosis, ALS, Parkinsons, dementia).
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- Any history of dysphagia from prior stroke will be exclusionary.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Cincinnati | Cincinnati | Ohio | United States | 45220 |
Sponsors and Collaborators
- University of Cincinnati
- National Institutes of Health (NIH)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-0582 Lingual Endurance
- 1K01HD111680-01