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

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.

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Key information

Conditions

Bone Resorption Atrophy Bone Diseases Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

German Aerospace Center

Cologne, 51147, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HEPHAISTOS

Device

HEPHAISTOS unloading orthotic

Primary outcomes

Bone density as measured with pQCT

Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

DLR German Aerospace Center

Other

Registry information

Official study title

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.

Acronym: HEP

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Apr 12, 2012
Registry last updated: Aug 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed