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临床试验/NCT05733494
NCT05733494已完成不适用

Cross-Cultural Adaptation and Validation of the Italian Version of the Clinical Assessment of Dysphagia in Neurodegeneration (CADN)

Istituti Clinici Scientifici Maugeri SpA1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2022年4月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
1
主要终点
Clinical Assessment of Dysphagia in Neurodegeneration (CADN)

研究概览

简要总结

The English version of the "Clinical Assessment of Dysphagia in Neurodegeneration" (CADN), represents a rapid and valid clinical assessment tool for dysphagia in neurodegenerative population.

Currently, there is no validated tool in Italian specific for the clinical assessment of dysphagia in neurodegenerative disease with strong psychometric characteristics.

The present study aims to translate and validate the Italian version of CADN in neurodegenerative population. Psychometric properties will be measured.

详细描述

Most of patients with a neurodegenerative disease will develop swallowing impairments (dysphagia) during their disease progression (up to 80%- 100% in Parkinson disease and Amyotrophic Lateral Sclerosis).

Dysphagia is associated with serious clinical complications, particularly regarding loss of life quality, insufficient medication intake, malnutrition, dehydration, and aspiration with subsequent pneumonia, which is the leading cause of death in this population.

Early detection and measurement of dysphagia trough validated and standardized procedures plays a fundamental role in the clinical practice. Clinical assessment by a speech language pathologist (SLP) can provide early identification of dysphagia and its severity and direct clinical decision making.

The English version of the "Clinical Assessment of Dysphagia in Neurodegeneration" (CADN), represents a rapid and valid clinical assessment tool for dysphagia in neurodegenerative population.

Currently, there is no validated tool in Italian specific for the clinical assessment of dysphagia in neurodegenerative disease with strong psychometric characteristics.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • diagnosis of neurodegenerative disease according to the respective consensus criteria
  • >18 years old
  • able to provide informed consent
  • able to follow simple instructions
  • capable of sitting upright for anamnesis and examination for at least 20 min (in chair or wheelchair)

排除标准

  • history of stroke
  • surgery to the head or neck
  • radiotherapy in the last 12 months
  • dysphagia resulting from other known causes

研究组 & 干预措施

Patients with neurodegenerative disease

Patients with neurodegenerative disease

干预措施: Administration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN) (Other)

结局指标

主要结局

Clinical Assessment of Dysphagia in Neurodegeneration (CADN)

时间窗: at 24 hours from enrolment

Clinical assessment tool administrated by a Speech Language Pathologist. The CADN is composed by a clinical case history and a consumption part for a total of 11 item. Severity scores for each item range from 0 (no impairment) to 4 (severe impairment).

Clinical Assessment of Dysphagia in Neurodegeneration (CADN)

时间窗: at the enrolment

Clinical assessment tool administrated by a Speech Language Pathologist. The CADN is composed by a clinical case history and a consumption part for a total of 11 item. Severity scores for each item range from 0 (no impairment) to 4 (severe impairment).

次要结局

  • Fiberoptic Endoscopic Evaluation of Swallowing (FEES)(At the enrolment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Micol Castellari

Speech-Language Pathologist

Istituti Clinici Scientifici Maugeri SpA

研究点 (1)

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