RECRUITING

K01 Impacts of Lingual Endurance Exercise

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-09-01
Study Completion:2028-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06072924

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 1\) 3-6 months since most recent diagnosis of ischemic, confirmed from clinical imaging) with or without small hemorrhagic transformation (HI-1)
  2. * 2\) Have some indication of on-going swallowing issues
  3. * 3\) English Speaking
  1. * 1\) ≤18 years of age
  2. * 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. * 3\) history of other neurological disease (i.e. multiple sclerosis, ALS, Parkinson's, dementia).
  4. * 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).

Contacts and Locations

Study Contact

Anna Hopkins, MS
CONTACT
+1 513 558 4152
hopkiak@ucmail.uc.edu
Rebecca Reinert
CONTACT
+1 513 558 1719
gibsonrk@ucmail.uc.edu

Principal Investigator

Brittany N Krekeler, PhD
PRINCIPAL_INVESTIGATOR
University of Cincinnati

Study Locations (Sites)

University of Cincinnati
Cincinnati, Ohio, 45220
United States

Collaborators and Investigators

Sponsor: University of Cincinnati

  • Brittany N Krekeler, PhD, PRINCIPAL_INVESTIGATOR, University of Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-01
Study Completion Date2028-08-31

Study Record Updates

Study Start Date2023-09-01
Study Completion Date2028-08-31

Terms related to this study

Keywords Provided by Researchers

  • swallowing trouble
  • difficulty swallowing
  • swallow rehab

Additional Relevant MeSH Terms

  • Dysphagia
  • Dysphagia, Oropharyngeal
  • Ischemic Stroke
  • Stroke