Natural Evolution of Muscle Structure and Stiffness Following Brain Lesion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Muscle elasticity
研究概览
简要总结
We propose to carry out a single center, prospective, interventional trial to assess the natural evolution of lower limb muscle structure and muscle stiffness of hemiparetic patients following brain damage. Patients will be assessed two weeks, one month, three months and six months after their brain lesion.
Secondary objectives:
To compare the muscle stiffness and structure of patients who will develop muscle overactivity to patients who won't develop muscle overactivity.
To compare the muscle structure and muscle stiffness of the spastic lower limb muscles and the non-spastic lower limb muscles in the affected limb.
To compare the muscle structure and muscle stiffness of the affected and the non-affected lower limb.
To study the relationship between impairment and function by applying a comprehensive and original method to assess all aspects from muscle structure and mechanics to patient's functional capacities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male ≥ 18 years and ≤ 80 years at screening
- •Hemiparesis secondary to a first stroke or traumatic brain injury
- •< 1 month post-stroke/brain injury Subjects must meet all of the inclusion criteria in order to be eligible to participate in the study.
排除标准
- •Bilateral limb paresis
- •Major cognitive impairments limiting the functional evaluation
- •Neurological or orthopedic affection interfering with the paretic limbs function
- •Underlying neuromuscular disease (e.g. myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis)
- •Contraindication to perform MRI Subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
研究组 & 干预措施
Only one arm
干预措施: imaging (Diagnostic Test)
结局指标
主要结局
Muscle elasticity
时间窗: 2 weeks, 1 month, 3 months, 6 months after brain lesion
Muscle elasticity measured by shear wave elastography, expressed in m/s. A smaller shearwave velocity indicates a better outcome
次要结局
- muscle volume(2 weeks, 1 month, 3 months, 6 months after brain lesion)
- muscle fat fraction(2 weeks, 1 month, 3 months, 6 months after brain lesion)