Clinical Trial: The Novel Unloading Device "HEPHAISTOS" and Its Effects Upon Bone, Muscle and Vasculature

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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.

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.

Detailed Summary:

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.

Sponsor: DLR German Aerospace Center

Current Primary Outcome: Bone density as measured with pQCT [ Time Frame: 1 year ]

subjects will be followed for one year, starting from the onset of the study


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: DLR German Aerospace Center

Dates:
Date Received: April 3, 2012
Date Started: April 2011
Date Completion:
Last Updated: August 15, 2012
Last Verified: August 2012