The Novel Unloading Device "HEPHAISTOS" and Its Effects Upon Bone, Muscle and Vasculature (HEP)

August 15, 2012 updated by: DLR German Aerospace Center

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany, 51147
        • German Aerospace Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Unilateral orthotic intervention
The HEPHAISTOS orthotic was worn unilaterally for 56days by 11 healthy male subjects.
Device: HEPHAISTOS
HEPHAISTOS unloading orthotic

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DLR German Aerospace Center

Investigators

  • Study Director: Joern Rittweger, Prof. Dr., DLR German Aerospace Center
  • Principal Investigator: Tobias Weber, DLR German Aerospace Center
  • Principal Investigator: Michel Ducos, DLR German Aerospace Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

April 3, 2012

First Submitted That Met QC Criteria

April 11, 2012

First Posted (ESTIMATE)

April 12, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 16, 2012

Last Update Submitted That Met QC Criteria

August 15, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DLR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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