RecruitingNot ApplicableNCT06072924

K01 Impacts of Lingual Endurance Exercise

Impact of Lingual Endurance Exercise on Rehabilitation of Swallowing Impairments After Ischemic Stroke


Sponsor

University of Cincinnati

Enrollment

70 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria4

  • \) ≤18 years of age
  • \) 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
  • \) history of other neurological disease (i.e. multiple sclerosis, ALS, Parkinson's, dementia).
  • \) 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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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


Locations(1)

University of Cincinnati

Cincinnati, Ohio, United States

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NCT06072924


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