NCT06072924

K01 Impacts of Lingual Endurance Exercise

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This randomized, controlled clinical trial investigates the efficacy of a 8-week lingual endurance exercise program in adults with dysphagia following stroke. The study uses a two-arm, parallel-group design with participants randomized to either a lingual endurance exercise group or a sham therapy control group. Both interventions are delivered using a lingual manometer, which participants use at home under monitored conditions. The primary aim is to evaluate changes in oral-phase swallowing physiology using the Modified Barium Swallow Impairment Profile (MBSImP) Oral Total Score, as assessed through video-fluoroscopic swallowing study (VFSS). An exploratory aim will assess potential neuroplasticity associated with lingual endurance exercise using multimodal neuroimaging. Participants who meet MRI eligibility criteria undergo pre- and post-intervention imaging, including diffusion tensor imaging (DTI) to assess white matter integrity, high-resolution structural imaging for cortical thickness estimation, and functional MRI (task-based and resting state). Data will be used to evaluate intervention-related changes in regions associated with swallowing motor control and sensory integration. This study also supports the investigator's training in clinical trial methodology, swallowing outcomes analysis, and neuroimaging techniques, and will inform a future, fully powered efficacy trial.

Conditions

• Dysphagia
• Dysphagia, Oropharyngeal
• Ischemic Stroke
• Stroke

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-01
• Primary completion: 2027-08-31
• Completion: 2028-08-31
• First posted: 2023-10-10
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States