Clinical trial NCT06072924: K01 Impacts of Lingual Endurance Exercise
Official title: Impact of Lingual Endurance Exercise on Rehabilitation of Swallowing Impairments After Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysphagia
Dysphagia, Oropharyngeal
Ischemic Stroke
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: TriHealth Inc.
First posted: 2023-10-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Sham Controlled
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 1) 3-6 months since most recent diagnosis of ischemic, confirmed from clinical imaging) with or without small hemorrhagic transformation (HI-1)
* 2) Have some indication of on-going swallowing issues
* 3) English Speaking

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, Parkinson's, dementia).
* 4) Medium to large hemorrhagic transformation/involvement documented on clinical stroke imaging 5) 5) History of temporomandibular joint and muscle disorders (also known as TMJ).

Primary outcomes:
measure: Modified Barium Swallow Study Impairment Profile Oral Total (MBSImP OT Score)
timeFrame: Change from Baseline (at the end of 8 weeks)
Secondary outcomes:
measure: Pharyngeal Swallow Efficiency
timeFrame: Change from Baseline (at the end of 8 weeks)
measure: Penetration Aspiration Scale (PAS) Scores
timeFrame: Change from Baseline (at the end of 8 weeks)
measure: Adherence
timeFrame: At the end of 8 weeks
measure: Pharyngeal Swallow Safety
timeFrame: Change from Baseline (at the end of 8 weeks)
measure: Maximum Isometric Pressure imaging with video-fluoroscopy
timeFrame: Change from Baseline (at the end of 8 weeks)
measure: Dietary Intake (Average Daily Calorie Intake) Outcome
timeFrame: Change from Baseline (at the end of 8 weeks)
measure: Food Textures Consumed Outcome
timeFrame: Change from Baseline (at the end of 8 weeks)
Other outcomes:
measure: Change in fractional anisotropy (FA)
timeFrame: Change from Baseline (at the end of 8 weeks)
measure: Change in cortical thickness
timeFrame: Change from Baseline (at the end of 8 weeks)
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Brittany N Krekeler, PhD
role: PRINCIPAL_INVESTIGATOR
References: