The Novel Unloading Device "HEPHAISTOS" and Its Effects Upon Bone, Muscle and Vasculature (HEP)
|ClinicalTrials.gov Identifier: NCT01576081|
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : August 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Bone Resorption||Device: HEPHAISTOS||Not Applicable|
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.
|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|
Experimental: Unilateral orthotic intervention
The HEPHAISTOS orthotic was worn unilaterally for 56days by 11 healthy male subjects.
HEPHAISTOS unloading orthotic
- Bone density as measured with pQCT [ Time Frame: 1 year ]subjects will be followed for one year, starting from the onset of the study
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|