Dysphagia, Dysphagia, Oropharyngeal, Ischemic Stroke, Stroke
Conditions
Keywords
swallowing trouble, difficulty swallowing, swallow rehab
Brief summary
The goal of this clinical trial is to learn whether a tongue endurance exercise program can improve swallowing function in adults with dysphagia after a stroke. It also aims to explore how this exercise may affect brain structure and connectivity involved in swallowing. The main questions it aims to answer are: Primary Aim: Does lingual endurance exercise improve swallowing function compared to a sham therapy? Secondary Aim: Does lingual endurance exercise lead to changes in brain structure or neuroplasticity, as measured by MRI? Researchers will compare a group receiving tongue endurance exercises to a sham therapy group to see whether the treatment improves tongue function, swallowing. Participants will: * Complete a baseline swallowing assessment and MRI * Be randomly assigned to either the lingual exercise or sham therapy group * Complete 8 weeks of home-based tongue exercise therapy * Return for follow-up swallowing assessments * A subgroup of participants will complete a pre-treatment and post-treatment MRI.
Detailed description
This randomized, controlled clinical trial investigates the efficacy of a 8-week lingual endurance exercise program in adults with dysphagia following stroke. The study uses a two-arm, parallel-group design with participants randomized to either a lingual endurance exercise group or a sham therapy control group. Both interventions are delivered using a lingual manometer, which participants use at home under monitored conditions. The primary aim is to evaluate changes in oral-phase swallowing physiology using the Modified Barium Swallow Impairment Profile (MBSImP) Oral Total Score, as assessed through video-fluoroscopic swallowing study (VFSS). An exploratory aim will assess potential neuroplasticity associated with lingual endurance exercise using multimodal neuroimaging. Participants who meet MRI eligibility criteria undergo pre- and post-intervention imaging, including diffusion tensor imaging (DTI) to assess white matter integrity, high-resolution structural imaging for cortical thickness estimation, and functional MRI (task-based and resting state). Data will be used to evaluate intervention-related changes in regions associated with swallowing motor control and sensory integration. This study also supports the investigator's training in clinical trial methodology, swallowing outcomes analysis, and neuroimaging techniques, and will inform a future, fully powered efficacy trial.
Interventions
BEHAVIORALIsotonic Endurance Exercise
Pressing tongue against a pressure sensor at the set number of repetitions per session (individualized per participant) 3 times per day
BEHAVIORALSham Exercise
Pressing tongue against pressure sensor at a low threshold (1-15kPa) 30x/day
Sponsors
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
TriHealth Inc.
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Sham Controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Pharyngeal Swallow Efficiency | Change from Baseline (at the end of 8 weeks) | Measurements via the ASPEKT method (Analysis of Swallowing Physiology: Events, Kinematics, and Timing) will be analyzed to compared pre and post treatment swallow efficiency. The amount will be presented as a percent of anatomical C2-C4 Scalar. Higher percentile, in general indicated greater impairment, however these will be compared to published normative data for reference. |
| 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 |
| Pharyngeal Swallow Safety | Change from Baseline (at the end of 8 weeks) | Closure above the airway must be achieved for swallowing safety and in a timely manner. The ASPEKT method (Analysis of Swallow Physiology: Events, Kinematics and Timing) will be used to analyze changes of laryngeal vestibule closure pre and post treatment. |
| Dietary Intake (Average Daily Calorie Intake) Outcome | Change from Baseline (at the end of 8 weeks) | A pre treatment and post treatment 24 hour dietary recall will be collected in a subset or participants. This information will be used for estimating nutrient and food group intake to characterize usual diet and to assess changes over time. Nutrition Data Systems for Research (NDSR) (Nutrition Coordinating Center, University of Minnesota, Minneapolis, MN) software and foods database will be used to assess average daily energy (kJ) intake over 3 days |
| Food Textures Consumed Outcome | Change from Baseline (at the end of 8 weeks) | A pre treatment and post treatment 24 hour dietary recall will be collected in a subset or participants. This information will be used for estimating nutrient and food group intake to characterize usual diet and to assess changes over time. Nutrition Data Systems for Research (NDSR) (Nutrition Coordinating Center, University of Minnesota, Minneapolis, MN) software and foods database will be used to assess the relative percentage (%) of dry texture food intake, on average, across three days |
| Maximum Isometric Pressure imaging with video-fluoroscopy | Change from Baseline (at the end of 8 weeks) | Maximum isometric press will be recorded in kPa and with recorded imaging using video-fluoroscopy. This will be collected pre- and post-therapy to determine any changes in oropharyngeal movements with a lingual press. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactAnna Hopkins, MS
Backup ContactRebecca Reinert
Outcome results
None listed