Dysphagia Evaluation After Stroke- Effect Oral Neuromuscular Training on Swallowing Dysfunction

Dysphagia Evaluation After Stroke - a Randomized Controlled Trial of Oral Neuromuscular Training on Swallowing Dysfunction (DESIRE)

The aim of this study is to investigate the effect of a specific rehabilitation program with an oral device used in stroke patients with persistent oral-and pharyngeal dysphagia.

This study aims to investigate the effect of oral neuromuscular training in stroke patients with persistent oral- and pharyngeal dysphagia 12 (±3) weeks after stroke onset.

Interventional study with PROBE-design (prospective randomized open-label blinded evaluator). Consecutive patients with first-ever stroke 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, Danderyds Hospital, Södersjukhuset, Skaraborg Hospital (Skövde), Helsingborg Hospital, Halland Hospital, Kungälv Hospital, Kalix Hospital, Skellefteå Hospital, and Ellenbogen in Malmö. Further centers will be recruited. Exclusion criteria: Unable/unwilling to give informed consent or to cooperate.

Randomization will be made web-based 1:1 by use of the developed REDCap system with stratification for center and aspiration (yes/no).

In total, 336 stroke patients (168 intervention group; 168 control group) with persistent dysphagia 12(±3) weeks after stroke onset will be included in the present study. The intervention group will be offered to undergo oral neuromuscular training alongside routine care with compensatory training for 3 months. The control group will only be offered routine care with compensatory training for 3 months.

The participants' status regarding swallowing function, nutritional status, quality of life related to swallowing, pneumonia, functional status including lip force, and death will be assessed before and after the completed intervention period, and 6 months post-intervention.

The primary endpoint will be analyzed using an ordinal regression (proportional odds) model, adjusting for baseline DOSS as well as for the stratifying variables center and aspiration.

The investigators hypothesize that swallowing intervention with oral neuromuscular training is more effective than routine care rehabilitation.

Inclusion Criteria:

• Persistent dysphagia 12(±3) weeks after STROKE.

Exclusion Criteria:

• Stroke patients with neurologic or psychiatric disorders or other diseases/conditions that can affect swallowing function.
• Unable to collaborate due to other serious diseases and/or to affected general condition.