Assessing Fatiguability of Tongue Muscles and the Effect on Tongue Strength and Swallowing Pressures in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Evolution of MIP during subsequent repetitions
研究概览
简要总结
Multiple Sclerosis (MS) patients with subjective dysphagia will be tested for tongue strength fatigue using a strictly defined fatigue paradigm. A maximum of 40 sets will be performed, each set consisting of 5 repetitions of 80% of maximum isometric pressure (MIP) at the anterior tongue, followed by a MIP at the anterior tongue. Cut-off criteria are a MIP <50% of the baseline MIP, pronounced subjective discomfort and/or exceeding the allocated test time of 30 minutes.
详细描述
Eligibility is Mini-Mental State Exam-score (MMSE) > 23, a Eating Assessment Tool-score (EAT-10) > 3, or a Functional Oral Intake Scale-score (FOIS) < 7, or failing the Yale Swallow Protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •proven MS
- •subjective dysphagia
排除标准
- •MMSE < 23
- •major head and neck surgery
- •history of cancer
研究组 & 干预措施
Iowa Oral Performance Instrument (IOPI)
All MS patients will be included in this arm to compare with a historical control arm. Iowa Oral Performance Instrument (IOPI).
干预措施: Iowa Oral Performance Instrument (IOPI) (Device)
结局指标
主要结局
Evolution of MIP during subsequent repetitions
时间窗: 30 minutes
The change in MIP after each 5 repetitions.
Number of successful repetitions
时间窗: 30 minutes
The number of repetitions where the target force was developed.
次要结局
- Baseline MIP as predictor for number of repetitions(30 minutes)
研究者
Jan Vanderwegen
Principal Investigator, Clinical Professor
Thomas More Kempen