Lingual Endurance Exercise in Treating Post-Stroke Dysphagia
Completed · Not applicable
Conditions studied: Dysphagia, Oral Phase, Stroke, Ischemic
In brief
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).
Key facts
- Study ID
- NCT05523973
- Run by
- University of Cincinnati
- People needed
- 19
- Starts
- 2022-08-02
- Expected to finish
- 2023-11-28
- Last updated by the study team
- 2025-05-07
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
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
- English speaking. Participants will not be considered for inclusion if they meet any of the following screening exclusion criteria
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
Where it is running
- Medical Sciences Building — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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