Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2023-09-01
2028-08-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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, and re-evaluated every 2 weeks, for each participant.
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 Exercise
The sham control group will be instructed to press the lingual sensor 30 times at a very low-pressure threshold (approximately 1-15 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.
Sham Exercise
Pressing tongue against pressure sensor at a low threshold (1-15kPa) 30x/day
Interventions
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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 Exercise
Pressing tongue against pressure sensor at a low threshold (1-15kPa) 30x/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 2\) Have some indication of on-going swallowing issues
* 3\) English Speaking
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
TriHealth Inc.
OTHER
University of Cincinnati
OTHER
Responsible Party
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Brittany Krekeler
Assistant Professor
Principal Investigators
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Brittany N Krekeler, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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University of Cincinnati
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Anna Hopkins, MS
Role: primary
Other Identifiers
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2023-0582 Lingual Endurance
Identifier Type: -
Identifier Source: org_study_id