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

Bone Resorption Clinical Trial

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.

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bone Resorption

• NCT number: NCT01576081
• Study type: Interventional
• Source: DLR German Aerospace Center
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Completion date: July 2012