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Completed

NCT Number: NCT03086187

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

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.

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Key information

Conditions

Muscle; Atrophy, General Atrophy Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

German Aerospace Center

Cologne, North Rine Westphalia, 51147, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hephaistos unloading orthosis

Device

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

Primary outcomes

  1. Bone density as measured with pQCT

    Time frame: At baseline and up to 12 months after the immobilization phase

    Change from baseline to 14 days after immobilization phase

Secondary outcomes

  1. Structural and functional parameters of arterial adaptation

    Time frame: At baseline and up to 12 months after the immobilization phase

    Change in intima & media thickness.

  2. Structural and functional parameters of arterial adaptation

    Time frame: At baseline and up to 12 months after the immobilization phase

    Change in arterial diameter

  3. Structural and functional parameters of arterial adaptation

    Time frame: At baseline and up to 12 months after the immobilization phase

    Change in blood flow

  4. Structural and functional parameters of arterial adaptation

    Time frame: At baseline and up to 12 months after the immobilization phase

    Change in flow-mediated dilation

Sponsors and collaborators

Lead sponsor

DLR German Aerospace Center

Other

Registry information

Official study 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

Acronym: HEP

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Mar 22, 2017
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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