The Novel Unloading Device "HEPHAISTOS" and Its Effects Upon Bone, Muscle and Vasculature

DLR German Aerospace Center11 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Bone Resorption

Interventions

HEPHAISTOSDEVICE

HEPHAISTOS unloading orthotic

Eligibility

Sex: MALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

German Aerospace Center

Cologne, Germany

Outcomes

Primary Outcomes

Bone density as measured with pQCT

subjects will be followed for one year, starting from the onset of the study

Time frame: 1 year

Data from ClinicalTrials.gov

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