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

Bone Resorption Clinical Trial

— HEP  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576081
• Other study ID #: DLR
• Status: Completed
• Phase: N/A
• First received: April 3, 2012
• Last updated: August 15, 2012
• Start date: April 2011
• Est. completion date: July 2012

Study information

• Verified date: August 2012
• Source: DLR German Aerospace Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Office for Radiation Protection
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• male

• age: 20-40 years

• BMI: 20-30

• passing the psychological and medical check up.

• signed consent to participate in the study

• faultless certificate of good conduct

Exclusion Criteria:

• smoking

• professional athletes

• diabetes

• muscle or joint disease

• trabecular bone density in the distal tibia epiphysis < 160mg/cm3

• increase risk of thrombosis

• bone fractures 12 months prior to the study

• metal implants, any material of osteosynthesis

• participation in another clinical intervention study 2 months prior to the study

• bleeding disorder

• anesthetic intolerance

• vascular disease

• epilepsy

• claustrophobia

• herniated disk

• pacemaker

• alcohol or drug abuse

• anti-inflammatory drug intake during the study

• hyperlipidemia

• kidney disease

• hyperhomocysteinaemia

• vitamin d deficit

• chronical back pain

• detained

Study Design

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

Related Conditions & MeSH terms

• Bone Resorption

Intervention

Device:
• HEPHAISTOS
HEPHAISTOS unloading orthotic

Locations

Country	Name	City	State
Germany	German Aerospace Center	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
DLR German Aerospace Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone density as measured with pQCT	subjects will be followed for one year, starting from the onset of the study	1 year	Yes

External Links

•   Webpage German Aerospace Center (DLR), Division Space Physiology