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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.|
- Bone density as measured with pQCT [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]subjects will be followed for one year, starting from the onset of the study
|Study Start Date:||April 2011|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: Unilateral orthotic intervention
The HEPHAISTOS orthotic was worn unilaterally for 56days by 11 healthy male subjects.
HEPHAISTOS unloading orthotic
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576081
|German Aerospace Center|
|Cologne, Germany, 51147|
|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|