Measure of the Strength of the Tongue in Patients With Amyotrophic Lateral Sclerosis and Relation With Swallowing Disorders
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Maximum tongue strength
研究概览
简要总结
Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease with a poor prognosis that occurs in adults 64 years on average. Its prevalence is 4 to 6/100 000 inhabitants.
Swallowing disorders occur during evolution and involve the prognosis of patients in the short term by the association of dysphagia with severe malnutrition, and aspiration. The issue of phoniatric monitoring is to detect early onset of the swallowing disorders to develop strategies for respiratory protection, food adapted to disturbances, and speech therapy.
The objective of this study is to compare the tongue force in patients with amyotrophic lateral sclerosis at the time of diagnosis and at the onset of swallowing disorders compared to healthy subjects, with the dynamic palatography device developed in the Laboratoire Parole et Langage (UMR 7309, CNRS-Université Aix-Marseille, Aix-en-Provence), which allows the measurement of the strength and duration of the pression of the tongue on the palate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Adults and legally responsible/ valid medical insurance
- •patients : ALS diagnostic already announced
- •healthy subjects : EAT-10 score<2
排除标准
- •Non pregnant and non baby feeding
- •Presence of risk factor or suspicion of Creutzfeld Jacob Disease
- •Allergy/intolerance to the glueing paste
- •Antecedent of pathology of the aerodigestive tract
- •Other neurologic disease
- •Morphologic anomaly of the aerodigestive tract
- •Excessive gag reflex
研究组 & 干预措施
healthy volunteers
Constitution of a control group consisting of 20 healthy volunteers, matched for age and sex to establish a "normal" pressure force of the language depending on the age and sex value
干预措施: medical device (Device)
Patients with Amyotrophic Lateral Sclerosis
Constitution of a group of 20 patients with Amyotrophic Lateral Sclerosis (ALS), included at diagnosis of the disease on clinical and electromyographic arguments addressed in speech pathology consultation without a complaint swallowing.
干预措施: medical device (Device)
patients with Amyotrophic Lateral Sclerosis and swallowi
Constitution of a group of 20 patients with Amyotrophic Lateral Sclerosis ( ALS) and swallowing disorders clinically objectified in the ENT consultation.
干预措施: medical device (Device)
结局指标
主要结局
Maximum tongue strength
时间窗: 30 minutes
maximal tongue strength during salivary swallowing
Tongue contact duration
时间窗: 30 minutes
Duration of tongue and palate contact during salivary
次要结局
未报告次要终点