跳至主要内容
临床试验/NCT07503145
NCT07503145进行中(未招募)不适用

Translation and Validation of a Swallowing Assessment Scale for Neurogenic Dysphagia

IRCCS San Camillo, Venezia, Italy1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年5月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
1
主要终点
Presence of tracheostomy tube and secretion management status

研究概览

简要总结

The Munich Swallowing Score (MUCSS) is a tool that evaluates saliva, liquid, and food swallowing abilities using two scales: one for saliva/secretions (MUCSS-S) and one for nutrition (MUCSS-N). It helps objectively assess swallowing function and track changes over time. Validating the MUCSS in Italian would aid in better managing neurogenic dysphagia patients.

详细描述

Neurogenic dysphagia is a swallowing disorder resulting from neurological diseases, primarily characterized by alterations in the oral and pharyngeal phases. Neurogenic dysphagia is a very common disorder, affecting 40-70% of individuals who have had a stroke and 60-80% of those with neurodegenerative diseases in Physical Medicine and Rehabilitation and Neurorehabilitation settings. The main complications of dysphagia are aspiration pneumonia, malnutrition, and dehydration, which can worsen the clinical picture and compromise the patient's quality of life. To identify swallowing disorders early and prevent complications, it is recommended to use standardized screening protocols and clinical evaluation by a speech therapist. If clinical questions remain, further investigation with instrumental exams such as videofluoroscopy (VFS) and/or fibroscopy is indicated. Within clinical evaluation, it is advisable to use outcome scales to objectively determine the severity of the disorder, describe the functional level of swallowing abilities, and monitor the evolution of the function over time.

The Munich Swallowing Score (MUCSS) [Bartolome G, 2021] is a clinical tool used to assess the functional level of saliva/secretions, liquids, and food swallowing. It consists of two scales, each with eight levels: the Munich Swallowing Score-Saliva (MUCSS-S), which evaluates the management of saliva/secretions, and the Munich Swallowing Score-Nutrition (MUCSS-N), which focuses on nutrition.

In the literature, the assessment of saliva/secretions management is still insufficiently explored. Difficulties in swallowing and managing saliva/secretions significantly affect the clinical progress of the patient and their quality of life. In this sense, a scale that considers both saliva/secretions swallowing and the presence of a cannula, in addition to liquid/food swallowing, represents an innovative and useful tool in clinical practice.

The MUCSS is a scale sensitive to the evolution of swallowing abilities, allowing an objective and repeatable evaluation of the management of secretions as well. The translation into Italian and validation of the MUCSS scale would provide an important contribution to the assessment and, consequently, the management of patients with neurogenic dysphagia.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Neurological etiology including stroke, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, cerebrovascular infection, spinocerebellar ataxia, myasthenia gravis, anoxia, brain tumor, or traumatic brain injury Diagnosed oropharyngeal dysphagia (OD) confirmed by a neurologist Age ≥ 18 years

排除标准

  • Inability to maintain a stable sitting position during endoscopy Contraindications to Fiberoptic Endoscopic Evaluation of Swallowing (FEES), including fever or agitation that compromises participation

研究组 & 干预措施

patients with neurogenic dysphagia

Patients with neurogenic dysphagia of different etiologies (Parkinson's disease, ALS, MS, stroke, traumatic brain injury, severe acquired brain injury)."

干预措施: Clinical assessment tool (Other)

结局指标

主要结局

Presence of tracheostomy tube and secretion management status

时间窗: 7 days

Assessment of tracheostomy tube presence and secretion management in relation to nutritional modality (oral vs non-oral feeding).

次要结局

未报告次要终点

研究者

发起方
IRCCS San Camillo, Venezia, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Nordio

PhD

IRCCS San Camillo, Venezia, Italy

研究点 (1)

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