Dysphagia Evaluation After Stroke- Incidence and Effect of Oral Screen Intervention on Swallowing Dysfunction
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Dysphagia
- Stroke
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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 oral-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 oral-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 3 months. The control group will only be offered traditionally compensatory training for 3 months. The participants' status regarding swallowing function, dysarthria, oral health, quality of life related to swallowing and somatic-and neurologic function will be assessed before and after completed intervention period, and 12-18 months post-intervention. The investigators hypothesis that swallowing intervention with oral screen is more effective than traditional rehabilitation.
Tracking Information
- NCT #
- NCT02960737
- Collaborators
- University Hospital, Umeå
- Investigators
- Principal Investigator: Per Wester, Professor Umeå University