NCT03086187已完成不适用
The Effects of a 56day Unilateral Muscular Unloading Intervention With a Novel Device That Allows Normal Ambulation While Reducing Muscle Activation Drastically, on Muscles, Bones and Vessels
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Bone density as measured with pQCT
研究概览
简要总结
11 healthy men used the HEPHAISTOS unloading orthosis in an ambulatory 8 week intervention study.
It greatly reduces calf muscle forces without reducing ground reaction forces.
详细描述
The 56day unloading intervention with HEPHAISTOS had the following key objectives:
- Primary objective: Assessment and evaluation of bone adaptation.
- Secondary objective: Assessment and evaluation of functional and structural muscular adaptations.
- Third objective: Assessment and evaluation of functional and structural vascular adaptations.
- Fourth objective: Assessment and evaluation if the present findings deviate from findings observed in established unloading models.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age: 20-45
- •BMI: 20-30
排除标准
- •professional sports men
- •rheumatism
- •muscle and joint disease
- •bone fractures within 12 months prior to the study
- •cruciate ligament rupture within 10 years prior to the study
- •metal implants
- •participation in any other clinical study within 2 months prior to the study haemophilia
- •any blood vessel disease
- •claustrophobia
- •herniated disk
- •cardiac pulse generator
- •drug or alcohol abuse
- •hyperlipidaemia
- •kidney disease
- •hyperhomocysteaemia
- •hyper/hypouricemia
- •hyper/hypocalcaemia
- •vitamin d deficit
- •chronical back pain
- •deficient certificate of good conduct
- •achilles tendon injury
结局指标
主要结局
Bone density as measured with pQCT
时间窗: At baseline and up to 12 months after the immobilization phase
Change from baseline to 14 days after immobilization phase
次要结局
- Structural and functional parameters of arterial adaptation(At baseline and up to 12 months after the immobilization phase)
研究者
研究点 (2)
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