Evaluation of Oral Screen Training With IQoro as Treatment for Dysphagia After Stroke
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in swallowing function due to aspiration and penetration.
研究概览
简要总结
Purpose The purpose of the study is to evaluate if training with oral screen IQoro® improves swallowing in patients with dysphagia after stroke.
Method Inpatient from a stroke unit in Sweden who have been assessed with fiberoptic endoscopic evaluation of swallowing(FEES) which proves swallowing difficulties (dysphagia) were recruited. The participants were randomise to control- or intervention group. Both groups received usual care. The intervention group were instructed to oral screen (IQoro®) training for 13 weeks. Follow up with FEES was made 13 weeks post of recruitment. The assess with FEES was recorded and the recordings are going to be analyzed afterwards to compare the swallowing ability between baseline and follow up in group and between group.
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
- None
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
- •Inpatient at stroke unit at Vrinnevisjukhuset ward 1, due to stroke.
- •Patient assessed to have dysphagia (score ≥1 on one of the studied parameters)according to FEES.
- •Patient who is able to handle IQoro® according to instructions, independently or with support of assistance from relatives or staff.
排除标准
- •Patients with dysphagia of a cause other than stroke.
- •Patient with impaired cognitive skill, motor and / or language ability that prevents the possibility of performing training with IQoro®, despite possible support from assistance from relatives or staff.
- •Patient who wishes training with the Muppy oral screen® related to saliva leakage.
结局指标
主要结局
Change in swallowing function due to aspiration and penetration.
时间窗: From baseline to follow up (13 weeks after baseline).
Changes in swallowing function based on the parameters aspiration and penetration in the pharynx. Estimates from "Penetration aspiration scale", 0-8. 0= No entry of material into the larynx or trachea, 8= Materials enter the trachea with no attempt to clear. Estimates are based on recording from FEES.
Change in swallowing function due to residual in the pharynx.
时间窗: From baseline to follow up (13 weeks after baseline).
Change in swallowing function due to residual in the pharynx, 0-1. 0= No or a small amount of residual, 1= A pool of residual after the first swallow. Estimates are based on recording from FEES.
Change in swallowing function due to secretion in the pharynx.
时间窗: From baseline to follow up (13 weeks after baseline).
Changes in swallowing function based on the parameter secretion in the pharynx. Estimates from "Secretion severity rating scale", 0-3. 0= Normal rating and 3= Secretion in the laryngeal vestibule that are not cleared. Estimates are based on recording from FEES.
次要结局
- Change in swallowing function due to oral intake.(From baseline to follow up (13 weeks after baseline).)
- The patient's experience of swallowing(From baseline to follow up (13 weeks after baseline))
研究者
Rebecca Norrman and Elin Rova
Speech and language pathologists
Ostergotland County Council, Sweden