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

Not Applicable

Completed

• Conditions: Muscle; Atrophy, General
• Interventions: Device: Hephaistos unloading orthosis

• Registration Number: NCT03086187
• Lead Sponsor: DLR German Aerospace Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-08
• Study Completion: 2012-07
• Study First Submitted: 2012-07-31
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-15
• Last Update Submitted: 2017-03-15
• Study First Posted: 2017-03-22
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hephaistos unloading orthosis	Hephaistos unloading orthosis	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.

Primary Outcome Measures

Name	Time	Method
Bone density as measured with pQCT	At baseline and up to 12 months after the immobilization phase	Change from baseline to 14 days after immobilization phase

Secondary Outcome Measures

Name	Time	Method
Structural and functional parameters of arterial adaptation	At baseline and up to 12 months after the immobilization phase	Change in flow-mediated dilation

Trial Locations

Locations (1)

German Aerospace Center; 🇩🇪 Cologne, North Rine Westphalia, Germany