K01 Impacts of Lingual Endurance Exercise

NCT06072924 | Recruiting

• 2 other identifiers: 2023-0582 Lingual Endurance1K01HD111680-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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; Stroke; Ischemic Stroke

Keywords

swallowing trouble; difficulty swallowing; swallow rehab

Outcome Measures

Primary Outcomes (1)

• Modified Barium Swallow Study Impairment Profile Oral Total (MBSImP OT Score)

  MBSImP is a validated, standardized tool for assessing oral, pharyngeal, and esophageal swallowing function. We will be using change in OT score (sum of components 1-6) as our primary outcome measure.

  Change from Baseline (at the end of 8 weeks)

Secondary Outcomes (7)

• Pharyngeal Swallow Efficiency

  Change from Baseline (at the end of 8 weeks)

• Penetration Aspiration Scale (PAS) Scores

  Change from Baseline (at the end of 8 weeks)

• Adherence

  At the end of 8 weeks

• Pharyngeal Swallow Safety

  Change from Baseline (at the end of 8 weeks)

• Maximum Isometric Pressure imaging with video-fluoroscopy

  Change from Baseline (at the end of 8 weeks)

Other Outcomes (2)

• Change in fractional anisotropy (FA)

  Change from Baseline (at the end of 8 weeks)

• Change in cortical thickness

  Change from Baseline (at the end of 8 weeks)

Study Arms (2)

Lingual Endurance Exercise

EXPERIMENTAL

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.

Behavioral: Isotonic Endurance Exercise

Sham Exercise

SHAM COMPARATOR

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.

Behavioral: Sham Exercise

Interventions

Isotonic Endurance Exercise BEHAVIORAL

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

Lingual Endurance Exercise

Sham Exercise BEHAVIORAL

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

Also known as: Learning group

Sham Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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

You may not qualify if:

• \) ≤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).

Sponsors & Collaborators

• University of Cincinnati: lead
• National Institutes of Health (NIH): collaborator
• TriHealth Inc.: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45220, United States

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders; Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Brittany N Krekeler, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Hopkins, MS

CONTACT

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

Rebecca Reinert

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized Sham Controlled

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 10, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)