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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01576081
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : August 16, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bone Resorption Device: HEPHAISTOS Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official 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.
Study Start Date : April 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: Unilateral orthotic intervention
The HEPHAISTOS orthotic was worn unilaterally for 56days by 11 healthy male subjects.
HEPHAISTOS unloading orthotic

Primary Outcome Measures :
  1. Bone density as measured with pQCT [ Time Frame: 1 year ]
    subjects will be followed for one year, starting from the onset of the study

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01576081

German Aerospace Center
Cologne, Germany, 51147
Sponsors and Collaborators
DLR German Aerospace Center
Study Director: Joern Rittweger, Prof. Dr. DLR German Aerospace Center
Principal Investigator: Tobias Weber DLR German Aerospace Center
Principal Investigator: Michel Ducos DLR German Aerospace Center

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: DLR German Aerospace Center Identifier: NCT01576081     History of Changes
Other Study ID Numbers: DLR
First Posted: April 12, 2012    Key Record Dates
Last Update Posted: August 16, 2012
Last Verified: August 2012

Keywords provided by DLR German Aerospace Center:
bone density
weight bearing
muscle atrophy
vascular degeneration
gravitational loading
muscular unloading

Additional relevant MeSH terms:
Bone Resorption
Bone Diseases
Musculoskeletal Diseases