Myotonia, Muscle Stiffness and Elasticity in Neuromuscular Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- MyotonPro device in patients with dystrophic and non-dystrophic myotonia
研究概览
简要总结
The primary objective of this study is to assess stiffness, muscle tone, relaxation periods and elasticity of various muscles in patients with dystrophic or non-dystrophic myotonia. The secondary objectives are (1) to provide reference values for stiffness, muscle tone, relaxation periods and elasticity of various muscles in patients with dystrophic or non-dystrophic myotonia; to provide reference values for stiffness, muscle tone, relaxation periods and elasticity of various muscles in patients with non-myotonic neuromuscular disorders, (3) assess correlations between to compare result values for stiffness, muscle tone, relaxation periods and elasticity with clinical muscle function tests, measured by clinical evaluation (MRC-scale) and the 6-minute walk test; (4) assess correlations between subcutaneous fat and muscle thickness and echogenicity, measured by muscle ultrasound and result values for stiffness, muscle tone, relaxation periods and elasticity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 否
入选标准
- •For Patients:
- •≥18 years of age
- •Confirmed neuromuscular disease
- •written consent
- •able and willing to perform study prodcedures
- •For healthy volunteers:
- •age ≥18 years of age
- •written informed consent
- •no clinical sign for neuromuscular disorders
排除标准
- •Severe comorbidities
- •Patient is participating in another clinical study using investigational treatment
- •Patient cannot perform required muscle function tests
- •the patient, in the opinion of the investigator, is unable to adhere to the requirements of the study
结局指标
主要结局
MyotonPro device in patients with dystrophic and non-dystrophic myotonia
时间窗: 1 day
The primary objective of this study is the comparison of viscoelastic stiffness of the underlying tissue measured by stiffness (S), elasticity (D) and relaxation (R) between patients with dystrophic and non-dystrophic myotonia.
次要结局
- MyotonPro device - reference values in patients with non-myotonic neuromuscular disorders(1 day)
- MyotonPro device - correlations between stiffness, muscle tone, relaxation periods and elasticity and the 6-minute-walk test(1 day)
- MyotonPro device - correlations between stiffness, muscle tone, relaxation periods and elasticity with subcutaneous fat and muscle thickness and echogenicity(1 day)
- MyotonPro device - reference values in patients with dystrophic and non-dystrophic myotonia(1 day)
- MyotonPro device - correlations between stiffness, muscle tone, relaxation periods and elasticity with clinical muscle function tests(1 day)
研究者
Prof. Dr. Benedikt Schoser
Prof. Dr. med. Benedikt Schoser
LMU Klinikum