Dysphagia Evaluation After Stroke- Incidence and Effect of Oral Screen Intervention on Swallowing Dysfunction "DESIRE"

Not yet recruiting

Phase N/A Results N/A

Trial Description

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

Detailed Description

This study aims to investigate the effect of oral screen training in stroke patients with persistent oral- and pharyngeal dysphagia 6 (±2) weeks after stroke onset.
Interventional study with PROBE-design (prospective randomized open-label blinded evaluator). Randomization will be made web-based with minimization program. Patient with oro-and pharyngeal dysphagia within 96h after stroke stroke onset enrolled at Umeå stroke centre will be followed up at 6 (±2) weeks after stroke onset. Sixty stroke patients (30 intervention group; 30 control group) with persistent oro- and pharyngeal dysphagia 6 (±2) weeks after stroke onset will be included in the present study. The intervention group will be offered to undergo oral screen training alongside traditionally compensatory training for 6 months. The control group will only be offered traditionally compensatory training for 6 months.
The participants' status regarding swallowing ability, dysarthria, oral health, quality of life related to swallowing and somatic-and neurologic function will be assessed before and after completed intervention period, 3 months into the the intervention period and 12-18 months post-intervention.
The investigators hypothesis that swallowing intervention with oral screen is more effective than traditional rehabilitation.

Conditions

Interventions

  • Oral screen Device
    Intervention Desc: The oral screen is used for 30 seconds, three times a day, before meals and implies new possibilities for training of the orofacial muscles.
    ARM 1: Kind: Experimental
    Label: Intervention group
    Description: Intensive training with oral screen (intervention group) and traditional compensatory swallowing training under 6 months with start 6 (±2) weeks after stroke onset.

Outcomes

Type Measure Time Frame Safety Issue
Primary Swallowing ability At start, after 3 months, at end of treatment (after 6 months) and 12 (±3) months post-intervention
Secondary Swallowing function At start, at end of treatment (after 6 months) and 12 (±3) months post-intervention
Secondary Lip-force (LF) At start, after 3 months, at end of treatment (after 6 months) and 12 (±3) months post-intervention
Secondary Swallowing Quality of Life Questionnaire (SWAL-QOL) At start, at end of treatment (after 6 months) and 12 (±3) months post-intervention
Secondary Dysarthria At start, at end of treatment (after 6 months) and 12 (±3) months post-intervention
Secondary Oral Health At start, at end of treatment (after 6 months) and 12 (±3) months post-intervention
Secondary Activity of daily living (ADL) At start, at end of treatment (after 6 months) and 12 (±3) months post-intervention
Secondary Global disability At start, at end of treatment (after 6 months) and 12 (±3) months post-intervention
Secondary The National Institutes of Health Stroke Scale (NIHSS) At start

Sponsors