Chewing Efficiency Measured by a Two Colour Chewing Gum Test: a Marker of Insufficient Nutritional Intakes and Percutaneous Gastrostomy (PEG) Necessity in ALS Patients?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- - Chewing efficiency
研究概览
简要总结
Study aims: The primary aim is to determine whether chewing efficiency, determined by a two-colour mixing ability test, and maximum bite and lip force decrease in ALS patients.
详细描述
Study center: University Hospitals of Geneva Study type: Cohort study with matched controls Study population: 25 ALS patients included in the multidisciplinary cohort study of the University Hospital Geneva between October 2012 and October 2014 and followed for 3 years maximum and 25 controls, matched for age, sex and dental status.
Study duration: Inclusion from October 2012 to October 2016. Follow-up for 3 years.
Study hypothesis: Chewing efficiency, maximum bite and lip force decrease with time in ALS patients and may be a marker of texture adaptation and PEG necessity.
Study aims: The primary aim is to determine whether chewing efficiency, determined by a two-colour mixing ability test, and maximum bite and lip force decrease in ALS patients.
The secondary aims are to determine, in ALS patients, whether:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ALS patients
- •> 18 years
- •Participation in the cohort study
排除标准
- •Refusal of participating in the cohort study
- •Presence of PEG
结局指标
主要结局
- Chewing efficiency
时间窗: 5 years
次要结局
- Bite force(5 years)
- Lip force(5 years)
- Saliva volume(5 years)
- Calorie and protein intakes(5 years)
研究者
Genton Graf Laurence
MD
University Hospital, Geneva