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

Study Overview
=================
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: Primary objective: Assessment and evaluation of bone adaptation. Secondary objective: Assessment and evaluation of functional and structural muscular adaptations. Third objective: Assessment and evaluation of functional and structural vascular adaptations. Fourth objective: Assessment and evaluation if the present findings deviate from findings observed in established unloading models.

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.

Conditions
-----------------
Bone Resorption

Intervention / Treatment
-----------------
* Device: HEPHAISTOS


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unilateral orthotic intervention<br>The HEPHAISTOS orthotic was worn unilaterally for 56days by 11 healthy male subjects. | Device: HEPHAISTOS<br>* HEPHAISTOS unloading orthotic<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone density, weight bearing, muscle atrophy, vascular degeneration, gravitational loading, muscular unloading