Effect of Oral Neuromuscular Training on Swallowing Function and Time Until Decannulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Number of days from admission until decannulation
研究概览
简要总结
In this randomized controlled trial the investigators wish to investigate the effect of an oral neuromuscular training device (called IQoro) on swallowing function and time until decannulation from a tracheostomy tube, in patients admitted for neurorehabilitation due to a severe acquired brain injury.
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
- •Cuff tracheostomy tube
排除标准
- •Not able to comply with IQoro exercises
- •3 weeks evaluation stay at the hospital
研究组 & 干预措施
Usual care + IQoro
The intervention group receives usual training of swallowing function along with training 3 times each day with an IQoro oral screen
干预措施: IQoro (Device)
Usual care + IQoro
The intervention group receives usual training of swallowing function along with training 3 times each day with an IQoro oral screen
干预措施: Usual care for swallowing function (Other)
Usual care
The comparison group receives usual training of swallowing function
干预措施: Usual care for swallowing function (Other)
结局指标
主要结局
Number of days from admission until decannulation
时间窗: Number of days from baseline assessment until decannulation or right censoring at 365 days
Time from admission until decannulation from a tracheostomy tube. For patients still admitted, decannulation is determined from the clinicians and documented i medical records. For discharged patients, decannulation is determined through medical records.
次要结局
- Milliliters of saliva above the cuff(Daily measures for up to four weeks)
- Functional oral intake (FOIS)(Baseline and after four weeks)
- Iowa Oral Performance Instrument (IOPI)(Baseline and after four weeks)
- Penetration Aspiration Scale (PAS)(Baseline and after four weeks)
- Yale Pharyngeal Residue Scale(Baseline and after four weeks)
- Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS)(Baseline and after four weeks)