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K01 Impacts of Lingual Endurance Exercise

NCT06072924 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Isotonic Endurance Exercise

Pressing tongue against a pressure sensor at the set number of repetitions per session (individualized per participant) 3 times per day

BEHAVIORAL

Sham Exercise

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

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

    collaborator NIH

  • TriHealth Inc.

    collaborator OTHER

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Brittany N Krekeler, PhD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2027-08-31
Completion
2028-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06072924 on ClinicalTrials.gov