K01 Impacts of Lingual Endurance Exercise

Not Applicable

Recruiting

• Conditions: Dysphagia, Oropharyngeal; Ischemic Stroke; Dysphagia
• Interventions: Behavioral: Isotonic Endurance Exercise; Behavioral: Sham Exercise

• Registration Number: NCT06072924
• Lead Sponsor: University of Cincinnati

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.

Study Timeline

• Study Start: 2023-09-01
• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-10-02
• Study First Posted: 2023-10-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Primary Completion: 2027-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lingual Endurance Exercise	Isotonic 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.
Sham Exercise	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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.
Adherence	At the end of 8 weeks	number of repetitions attempted/total number of repetitions prescribed
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

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States