Recruiting

Lingual Endurance

Sponsor:

University of Cincinnati

Code:

NCT06072924

Conditions

Dysphagia

Dysphagia, Oropharyngeal

Ischemic Stroke

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Isotonic Endurance Exercise

Sham Exercise

Study Details

Brief 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

Dysphagia

Dysphagia, Oropharyngeal

Ischemic Stroke

Stroke

Study ID

NCT06072924

Start date

Sep 1, 2023

Status verified date

Dec, 2025

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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\) 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).

5\) 5) History of temporomandibular joint and muscle disorders (also known as TMJ).

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

sham comparator: 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.

Interventions

Isotonic Endurance Exercise

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

Sham Exercise

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

Primary outcome measure

  • Modified Barium Swallow Study Impairment Profile Oral Total (MBSImP OT Score) [ Time Frame: Change from Baseline (at the end of 8 weeks) ]

Central Contacts and Locations

Central contacts

Anna Hopkins, MS

+1 513 558 4152hopkiak@ucmail.uc.edu

Rebecca Reinert

+1 513 558 1719gibsonrk@ucmail.uc.edu

Locations

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Anna Hopkins, MS

+1 513 558 4152hopkiak@ucmail.uc.edu

Principal Investigator:

Brittany Krekeler, PhD

More Information

Sponsor

University of Cincinnati

Last update posted

Sep 4, 2026

Last verified

Dec, 2025

Keywords

  • swallowing trouble
  • difficulty swallowing
  • swallow rehab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2026-09-04.