The Novel Unloading Device "HEPHAISTOS" and Its Effects Upon Bone, Muscle and Vasculature (HEP)
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|ClinicalTrials.gov Identifier: NCT01576081|
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : August 16, 2012
|Condition or disease||Intervention/treatment|
|Bone Resorption||Device: HEPHAISTOS|
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|
|Primary Completion Date :||July 2012|
|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
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 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|