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
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 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
研究组 & 干预措施
Hephaistos unloading orthosis
Other
Hephaistos unloading orthosis: Calf muscle unloading: The 11 male subjects had to wear a novel orthosis for 8 weeks, which greatly reduces plantarflexor forces during gait.
干预措施: Hephaistos unloading orthosis (Device)
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 (1)
Loading locations...
相似试验
已完成
不适用
The Novel Unloading Device "HEPHAISTOS" and Its Effects Upon Bone, Muscle and VasculatureBone ResorptionNCT01576081DLR German Aerospace Center11
已完成
不适用
Effects of using an upper limb rehabilitation support system as voluntary practice on concentration and muscle activityhealthy adultJPRN-UMIN000048533Suzuka University of Medical Science14
尚未招募
3 期
In our study, we will look at patients who had surgery to repair rotator cuff (shoulder) muscles. We will give them exercises that reduce the strain (unload) on these muscles to see its effect on pain, function, kinesiophobia (fear of movement), and the thickness of the muscles themselves.CTRI/2024/07/069829MGM Institute of Physiotherapy
招募中
不适用
Effect of post-operative upper limb exercises on outcomes ofarteriovenous fistula in patients with chronic kidney diseaseCTRI/2020/07/026437Kasturba Medical College
招募中
不适用
Analysis of the effects of upper limb rehabilitation program in patients after stroke injecting with botulinum toxispasticitystrokeACTRN12617000262303The University of Physical Education150