Dysphagia Evaluation After Stroke - a Randomized Controlled Trial of Oral Neuromuscular Training on Swallowing Dysfunction (DESIRE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Swallowing Function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent dysphagia 12(±3) weeks after STROKE.
排除标准
- •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.
研究组 & 干预措施
Intervention group
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.
干预措施: Oral neuromuscular training using an oral device (Device)
Control group
Routine care with compensatory swallowing training under 3 months with starting 12 (±3) weeks after stroke onset.
结局指标
主要结局
Swallowing Function
时间窗: At start compared with at end of treatment (after 3 months)
Change in swallowing function measured by the Dysphagia Outcome Severity Scale (DOSS) using Fiberoptic endoscopic evaluation of swallowing (FEES)
次要结局
- Death(At start, at end of treatment (after 3 months) and 6 months post-intervention)
- Swallowing Quality of Life Questionnaire (SWAL-QOL)(At start, at end of treatment (after 3 months) and 6 months post-intervention)
- Swallowing function(At start and 6 months post-intervention)
- Lip-force (LF)(At start, at end of treatment (after 3 months) and 6 months post-intervention)
- Nutritional status(At start, at end of treatment (after 3 months) and 6 months post-intervention)
- Activity of daily living (ADL)(At start, at end of treatment (after 3 months) and 12-18 months post-intervention)
- Global disability(At start, at end of treatment (after 3 months) and 6 months post-intervention)
- Aspiration-pneumonia(At start, at end of treatment (after 3 months) and 6 months post-intervention)