A two-center prospective consecutive observational study with i) characterization of incidence of and factors related to dysphagia in the acute, subacute (3 months) and chronic (6-12 months post-stroke) phase, and ii) the association between dysphagia, poor oral health and mortality 12 months post-stroke. Inclusion criterion: First-ever acute stroke patients admitted to the acute stroke units within 96 hours of onset. Exclusion criteria: Previously known dysphagia; unable to cooperate.

Patients with first-ever stroke (ischemic or hemorrhagic) are screened for dysphagia in the acute phase (within 96 hours of onset) with the GUSS and oral health (revised oral assessment guide, ROAG) by a speech-language pathologist and a dental hygienist, respectively. Repeated dysphagia tests are performed at 3, 6- and 12-months post-stroke as long as the dysphagia persists. Stroke severity and type, length of hospital stay, form of discharge, number of readmissions, rate of aspiration-pneumonia and mortality within 12 months post-stroke will also be established for each participant. Data will be collected from the national quality register for stroke care, Riksstroke. The main outcome is presence of dysphagia measured with GUSS and survival time.

A prospective, register-based randomized (1:1), multicenter, open-label trial with blinded evaluators (PROBE-design).

Variables and measures

The primary endpoint is degree of swallowing dysfunction; examined instrumentally through the nose with flexible endoscopic evaluation of swallowing (FESS), using the Dysphagia Severity Outcome Scale (DOSS) for assessment. The DOSS is a widely used scale for measuring swallowing safety and efficacy on an ordinal scale and is based on the International Classification of Functioning, Disability and Health (ICF) classification. Secondary endpoints are changes in nutritional status, swallowing-related quality of life, rate of aspiration-pneumonia, functional status and death. Baseline and 3-month characteristics of the patients are collected from the national registry Riksstroke.

Material: Patient selection – population, sample

Patient selection: Consecutive patients with first-ever stroke (ischemic or hemorrhagic) without previously known dysphagia with persistent dysphagia (DOSS<6) at 3 months (12±3 weeks) post-stroke onset. Patients are eligible to participate if they are admitted to one of the following seven hospitals/centers in Sweden: Umeå University hospital, Kalix Hospital, Danderyds hospital, Stockholm South General Hospital, Skaraborg hospital (Skövde), Halland hospital, Kungälv hospital and Ellenbogen in Malmö. Further cites will be recruited. Exclusion criteria: Unable to give informed consent or to cooperate, previously diagnosed swallowing difficulties.

Randomization: 1:1 is performed web-based by use of the developed RedCap system with stratification for center and aspiration (yes/no) leading to equal balance of prognostic important variables at baseline.

Intervention group: Intensive oral neuromuscular training of orofacial and pharyngeal muscles with an oral device (IQoro® MYoroface, Sweden). Oral neuromuscular training includes, apart from the same compensatory actions as the control group, addition of increased sensory input and strengthen of the facial, oral and pharyngeal muscles. A sensor is attached on the surface of the oral device to register the frequency of training – which will give feedback to the patient and for data collection; thus, to facilitate compliance/adherence.