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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01576081

Acronym

HEP

Enrollment

Registered

2012-04-12

Start date

2011-04-30

Completion date

2012-07-31

Last updated

2012-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Resorption

Keywords

bone density, weight bearing, muscle atrophy, vascular degeneration, gravitational loading, muscular unloading

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 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.

Interventions

DEVICEHEPHAISTOS

HEPHAISTOS unloading orthotic

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026