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Background: Stroke affects over 1 million people in Europe and 25,000 in Sweden annually, with high mortality and disability rates. Dysphagia, a common post-stroke issue, occurs in over 50% of patients in the acute phase. Evidence-based studies are lacking on rehabilitative interventions to improve post-stroke dysphagia. Current management focuses on compensatory strategies, but oral neuromuscular training shows promising results. Challenges to rehabilitation programs include poor adherence and the need for effective monitoring technologies. The primary objective of the current trial is to investigate the impact of oral neuromuscular training with a sensor-equipped oral device on post-stroke dysphagia.

Methods: This national, multicenter, investigator-initiated, randomized, parallel-group trial compares the effect of oral neuromuscular training versus standard care in patients with post-stroke dysphagia. We will enroll 336 consecutive participants who have no prior history of dysphagia and exhibit persistent dysphagia 3 months following the onset of ischemic stroke or intracerebral hemorrhage. Participants will be randomly assigned in a 1:1 ratio to receive either a 12-week intervention consisting of standard routine care combined with oral neuromuscular training (using an oral device with sensors for adherence feedback) or current routine care alone. Standard routine care includes compensatory strategies such as bolus modification, adapted swallowing postures, and maneuvers. The primary outcome is the degree of dysphagia at end of intervention, assessed with Flexible Endoscopy Evaluation of Swallowing (FEES) by blinded evaluators, and analyzed with ordinal regression models. Secondary outcomes are changes in nutritional status, pneumonia, mortality, and quality of life after a 12-week intervention and at 6-month follow-up.

Discussion: This first randomized clinical trial in stroke rehabilitation on neuromuscular oropharyngeal training with sensors to facilitate adherence and comprehensive outcome measures will enable evaluation of this treatment with the potential for significant clinical impact for patients with dysphagia after stroke.

Trial registration: ClinicalTrials.gov, identifier: NCT02960737. First registered on 11 November 2016 and later modified to the present multicenter study design on 22 August 2023.