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

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

NCT03086187

Acronym

HEP

Enrollment

Registered

2017-03-22

Start date

2011-03-31

Completion date

2012-07-31

Last updated

2017-03-22

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

Conditions

Muscle; Atrophy, General

Keywords

weight bearing, muscle unloading, bone loss, arterial adaptation, muscular adaptation

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.

Interventions

DEVICEHephaistos unloading orthosis

The Hephaistos unloading orthosis greatly reduces plantarflexor muscle torque and plantarflexor muscle activation during any gait activity.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Structural and functional parameters of arterial adaptation	At baseline and up to 12 months after the immobilization phase	Change in intima & media thickness.

Countries

Germany

Outcome results

None listed

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