Lingual Endurance Exercise in Treating Post-Stroke Dysphagia

NCT05523973 | Completed Results

• 2 other identifiers: 2022-0218P2CHD101899
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Aim 1: Determine feasibility of lingual endurance training for individuals with persistent dysphagia after ischemic stroke. Primary outcome measures: % patient adherence (# of attempted repetitions/# prescribed repetitions) and % dose delivery (# of repetitions meeting goal/# prescribed repetitions). Aim 2: Determine preliminary efficacy of lingual endurance training on improving critical aspects of oropharyngeal swallowing (physiologic impairments, clearance of oropharyngeal residue, airway protection), functional oral intake, and patient reported swallowing quality of life in individuals with persistent dysphagia after ischemic stroke. Primary outcome measures: improvement on videofluoroscopic assessment of swallowing function using the gold standard Modified Barium Swallowing Impairment Profile (MBSImP) Overall Impression (OI) score and Functional Oral Intake Scale (FOIS) score. Secondary outcome measures: Analysis of Swallow Physiology, Events, Timing and Kinematics (ASPEKT); airway invasion - Penetration Aspiration Scale (PAS). Patient reported outcome measures: EAT-10 (Eating Assessment Tool) and the Swallowing Quality of Life Questionnaire (SWAL-QoL).

Conditions

Dysphagia, Oral Phase; Stroke, Ischemic

Keywords

swallowing; dysphagia; sub-acute stroke; tongue; exercise

Outcome Measures

Primary Outcomes (2)

• Adherence

  % \[(total number of days of attempted exercise/total number of days prescribed over 8 weeks of therapy)x100\]

  Assessed at 8 weeks (study completion)

• Change From Baseline Modified Barium Swallowing Impairment Profile (MBSImP) Oral Total Score

  Improvement on Oral Total (OT) score MBSImP; OT score minimum score (best) =0; OT maximum score (worst) = 22

  Baseline and 8 Weeks

Secondary Outcomes (8)

• Participant Improving Worst Penetration Aspiration Scale (PAS) Score

  Baseline and 8 Weeks

• Change From Baseline in Post-swallow Residue (Solid)

  Baseline and 8 Weeks

• Change From Baseline in Post-swallow Residue (Puree)

  Baseline and 8 Weeks

• Change From Baseline in Post-swallow Residue (Thin Liquids)

  Baseline and 8 Weeks

• Change From Baseline in Post-swallow Residue (Mildly Thick Liquids)

  Baseline and 8 Weeks

Study Arms (1)

Lingual Endurance Training

EXPERIMENTAL

Participants will complete lingual endurance training 2-3 times a day. Half of the participants will also complete a session of effortful swallows with the device.

Other: Lingual Endurance Training

Interventions

Lingual Endurance Training OTHER

Participants will participate in 3 training sessions per day for 8 weeks. Some participants will complete 3 sessions of lingual endurance exercise. For example, if the participant completed 100 repetitions during the baseline measurement, they would complete 75 repetitions during their exercise session. Other participants will complete effortful swallows during their 3rd training session. These participants will complete 30 swallows where they are instructed to press their tongue hard on the bulb and swallow their saliva.

Lingual Endurance Training

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥3 months since initial diagnosis ischemic, non-hemorrhagic stroke occurring in areas involving anterior or posterior circulation and affecting underlying cortical or subcortical structures (including brainstem)
• are safe to tolerate some oral intake required for assessment of swallowing function via Modified Barium Swallow Study
• able to follow 2-step commands

You may not qualify if:

• a 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, or a surgical procedure involving the pharynx or larynx
• a history of other neurological disease including traumatic brain injury, multiple sclerosis, Amyotrophic lateral sclerosis (ALS), Parkinson, or dementia
• Pregnant women
• Patients with a history of Temporomandibular joint dysfunction (TMJ) or Epilepsy

Sponsors & Collaborators

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

Study Sites (1)

Medical Sciences Building

Cincinnati, Ohio, 45220, United States

Location

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MeSH Terms

Conditions

Deglutition Disorders; Ischemic Stroke; Motor Activity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Brittany Krekeler, PI
• Organization: University of Cincinnati

krekelby@ucmail.uc.edu

5132272759

Study Officials

• Brittany Krekeler, PhD

  University of Cincinnati, Department of Otolaryngology-Head and Neck Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: Some participants will practice only lingual endurance exercise 3 times a day, others will have a effortful swallow exercise to practice in place of their third session.

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: September 1, 2022
• Study Start: August 2, 2022
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: May 7, 2025
• Results First Posted: May 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)