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

Study Overview
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Brief Summary
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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.

Detailed Description
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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, Skaraborg hospital (Skövde), Helsingborg hospital, Halland hospital, Kungälv 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.

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

Conditions
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Dysphagia, Stroke

Intervention / Treatment
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* Device: Oral neuromuscular training using an oral device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persistent dysphagia 12(±3) weeks after first time 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Intensive training with oral neuromuscular training using an oral device (intervention group) and routine care with compensatory swallowing training under 3 months with start 12 (±3) weeks after stroke onset. | Device: Oral neuromuscular training using an oral device<br>* The oral device is used for 30 seconds, three times a day, before meals and implies new possibilities for training of the orofacial and pharyngeal muscles.<br>|
| No Intervention: Control group<br>Routine care with compensatory swallowing training under 3 months with starting 12 (±3) weeks after stroke onset. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swallowing Function | Change in swallowing function measured by the Dysphagia Outcome Severity Scale (DOSS) using Fiberoptic endoscopic evaluation of swallowing (FEES) | At start compared with at end of treatment (after 3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swallowing function | Change in swallowing function measured by the Dysphagia Outcome Severity Scale (DOSS) using Fiberoptic endoscopic evaluation of swallowing (FEES) | At start and 6 months post-intervention | 
| Lip-force (LF) | Change in lip-force measured in newtons (N) with the Lip Force Meter LF100. | At start, at end of treatment (after 3 months) and 6 months post-intervention | 
| Swallowing Quality of Life Questionnaire (SWAL-QOL) | Change in quality of life related to swallowing measured by the SWAL-QOL questionnaire. | At start, at end of treatment (after 3 months) and 6 months post-intervention | 
| Nutritional status | Change in nutritional status measured with the Mini Nutritional Assessment (MNA). | At start, at end of treatment (after 3 months) and 6 months post-intervention | 
| Activity of daily living (ADL) | Change in activity of daily living (ADL) measured by Barthels Index (BI). | At start, at end of treatment (after 3 months) and 12-18 months post-intervention | 
| Global disability | Change in global disability measured with modified Rankin Scale (mRS) | At start, at end of treatment (after 3 months) and 6 months post-intervention | 
| Aspiration-pneumonia | Change in rate of aspiration-pneumonia based on the modified criteria by Centers for Disease Control and Prevention (CDC) for stroke-associated pneumonia | At start, at end of treatment (after 3 months) and 6 months post-intervention | 
| Death | Change in rate of death | At start, at end of treatment (after 3 months) and 6 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysphagia, Stroke, Intervention, Oral neuromuscular training, Randomized control trial