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K01 Impacts of Lingual Endurance Exercise

NCT ID: NCT06072924

Last Updated: 2024-12-27

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2028-08-31

Brief Summary

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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

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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.

Conditions

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Dysphagia Dysphagia, Oropharyngeal Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Sham Controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Isotonic Endurance Exercise

Intervention Type BEHAVIORAL

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.

Group Type SHAM_COMPARATOR

Sham Exercise

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Sham Exercise

Pressing tongue against pressure sensor at a low threshold (1-15kPa) 30x/day

Intervention Type BEHAVIORAL

Other Intervention Names

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Learning group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

TriHealth Inc.

OTHER

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Brittany Krekeler

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anna Hopkins, MS

Role: CONTACT

Phone: +1 513 558 4152

Email: [email protected]

Rebecca Reinert

Role: CONTACT

Phone: +1 513 558 1719

Email: [email protected]

Facility Contacts

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Anna Hopkins, MS

Role: primary

Brittany Krekeler, PhD

Role: backup

Other Identifiers

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1K01HD111680-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023-0582 Lingual Endurance

Identifier Type: -

Identifier Source: org_study_id