The Effects of the Novel Unloading Device HEPHAISTOS on Bone, Muscles and Vessels

Study Overview
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Brief Summary
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11 healthy men used the HEPHAISTOS unloading orthosis in an ambulatory 8 week intervention study. It greatly reduces calf muscle forces without reducing ground reaction forces.

Detailed Description
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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
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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
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Muscle; Atrophy, General

Intervention / Treatment
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* Device: Hephaistos unloading orthosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male age: 20-45 BMI: 20-30 Exclusion Criteria: smoking professional sports men diabetes rheumatism muscle and joint disease bone fractures within 12 months prior to the study cruciate ligament rupture within 10 years prior to the study metal implants participation in any other clinical study within 2 months prior to the study haemophilia any blood vessel disease epilepsy claustrophobia herniated disk cardiac pulse generator drug or alcohol abuse hyperlipidaemia kidney disease hyperhomocysteaemia hyper/hypouricemia hyper/hypocalcaemia anaemia vitamin d deficit chronical back pain deficient certificate of good conduct achilles tendon injury

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hephaistos unloading orthosis<br>Hephaistos unloading orthosis: Calf muscle unloading: The 11 male subjects had to wear a novel orthosis for 8 weeks, which greatly reduces plantarflexor forces during gait. | Device: Hephaistos unloading orthosis<br>* The Hephaistos unloading orthosis greatly reduces plantarflexor muscle torque and plantarflexor muscle activation during any gait activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone density as measured with pQCT | Change from baseline to 14 days after immobilization phase | At baseline and up to 12 months after the immobilization phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structural and functional parameters of arterial adaptation | Change in intima & media thickness. | At baseline and up to 12 months after the immobilization phase | 
| Structural and functional parameters of arterial adaptation | Change in arterial diameter | At baseline and up to 12 months after the immobilization phase | 
| Structural and functional parameters of arterial adaptation | Change in blood flow | At baseline and up to 12 months after the immobilization phase | 
| Structural and functional parameters of arterial adaptation | Change in flow-mediated dilation | At baseline and up to 12 months after the immobilization phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight bearing, muscle unloading, bone loss, arterial adaptation, muscular adaptation