Dysphagia evaluation after stroke – a randomized controlled trial of oral neuromuscular training on swallowing dysfunction (DESIRE)

This multicenter randomized control trial aims to investigate the effect of oral neuromuscular training with a novel oral device on dysphagia in patients with stroke.

Evidence-based randomized studies are lacking on rehabilitative intervention to improve swallowing on a biomechanical level after stroke.P: 336 consecutive participants without history of previous dysphagia and with persistent dysphagia 3 months after ischemic stroke or intracerebral hemorrhage onset will be randomized 1:1 for I: 3 months intervention with current routine care + oral neuromuscular training three times daily with an oral device, equipped with sensors for compliance feedback.C: The controls will be given current routine care with compensatory strategies such as bolus modification, adapted swallowing postures and maneuvers.

O: The primary outcome is change in the degree of dysphagia at end of intervention, assessed with nasoendoscopy by blinded evaluators, and analyzed with ordinal regression models.

Secondary outcome is change in nutritional status, pneumonia, mortality, and quality of life after 3 months intervention and at 6 months follow-up.If oral neuromuscular training improves swallowing function with a reduced risk of malnutrition, pneumonia, and early death, this will mean a breakthrough in the stroke field with a significant impact on the individual, relatives, healthcare, and socioeconomics.

Favorable results would be implemented in national and international stroke guidelines.