NCT06425445已完成不适用
Development of a New Clinical Tool for the Assessment of Orofacial Muscles in Patients Affected by Facioscapulohumeral Muscular Dystrophy: a Preliminary Study.
University of Mons2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2024年5月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- The pressure drop
研究概览
简要总结
The goal of this study is to validate a new method for the assessment of orofacial muscles in FSHD affected individuals
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Genetic diagnosis of FSHD type 1 and/or type 2
排除标准
- •Pregnant women
- •Presence of other associated neuromuscular conditions
- •Any unstable interfering clinical situation
结局指标
主要结局
The pressure drop
时间窗: The pressure drop will be assessed for each study participant at visit 1 and subsequently at visit 2 (3 months later). The measurements as such, should take about 30 minutes for each participant
The pressure drop (PD) is defined as the pressure difference between a reference ovoid-shaped mouthpiece and variously-sized circular mouthpieces, divided by the reference pressure. It is a relative value that is expected to reflect the magnitude of orofacial muscle dysfunction in FSHD affected individuals.
次要结局
未报告次要终点
研究者
Alexandre Legrand
Professor and Dean of the Faculty of Medicine and Pharmacy
University of Mons
研究点 (2)
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