NCT01576081

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: DLR German Aerospace Center · Academic / Other
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Bone Resorption

Interventions

Type	Name	Description
DEVICE	HEPHAISTOS	HEPHAISTOS unloading orthotic

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-04-12
• Last updated: 2012-08-16

Locations

1 site across 1 country: Germany