The Novel Unloading Device "HEPHAISTOS" and Its Effects Upon Bone, Muscle and Vasculature
- Conditions
- Bone Resorption
- Interventions
- Device: HEPHAISTOS
- Registration Number
- NCT01576081
- Lead Sponsor
- DLR German Aerospace Center
- Brief Summary
The present study aimed to investigate the importance of gravitational induced forces that appear during normal ambulation for the health of muscles, bones and blood vessels. The main hypothesis of the present study is that gravitational loading alone, without muscle contractions, is insufficient to maintain bone strength.
- Detailed Description
The 56day unloading intervention with HEPHAISTOS had the following key objectives:
1. Primary objective: Assessment and evaluation of bone adaptation.
2. Secondary objective: Assessment and evaluation of functional and structural muscular adaptations.
3. Third objective: Assessment and evaluation of functional and structural vascular adaptations.
4. Fourth objective: Assessment and evaluation if the present findings deviate from findings observed in established unloading models.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 11
- male
- age: 20-40 years
- BMI: 20-30
- passing the psychological and medical check up.
- signed consent to participate in the study
- faultless certificate of good conduct
- smoking
- professional athletes
- diabetes
- muscle or joint disease
- trabecular bone density in the distal tibia epiphysis < 160mg/cm3
- increase risk of thrombosis
- bone fractures 12 months prior to the study
- metal implants, any material of osteosynthesis
- participation in another clinical intervention study 2 months prior to the study
- bleeding disorder
- anesthetic intolerance
- vascular disease
- epilepsy
- claustrophobia
- herniated disk
- pacemaker
- alcohol or drug abuse
- anti-inflammatory drug intake during the study
- hyperlipidemia
- kidney disease
- hyperhomocysteinaemia
- vitamin d deficit
- chronical back pain
- detained
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Unilateral orthotic intervention HEPHAISTOS The HEPHAISTOS orthotic was worn unilaterally for 56days by 11 healthy male subjects.
- Primary Outcome Measures
Name Time Method Bone density as measured with pQCT 1 year subjects will be followed for one year, starting from the onset of the study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
German Aerospace Center
🇩🇪Cologne, Germany