The Effects of the Novel Unloading Device "HEPHAISTOS" on Bone, Muscles and Vessels
HEP
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
1 other identifier
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 31, 2012
CompletedFirst Posted
Study publicly available on registry
March 22, 2017
CompletedMarch 22, 2017
March 1, 2017
5 months
July 31, 2012
March 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Structural and functional parameters of arterial adaptation
At baseline and up to 12 months after the immobilization phase
Structural and functional parameters of arterial adaptation
At baseline and up to 12 months after the immobilization phase
Structural and functional parameters of arterial adaptation
At baseline and up to 12 months after the immobilization phase
Structural and functional parameters of arterial adaptation
At baseline and up to 12 months after the immobilization phase
Study Arms (1)
Hephaistos unloading orthosis
OTHERHephaistos 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.
Interventions
The Hephaistos unloading orthosis greatly reduces plantarflexor muscle torque and plantarflexor muscle activation during any gait activity.
Eligibility Criteria
You may qualify if:
- male
- age: 20-45
- BMI: 20-30
You may not qualify if:
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
German Aerospace Center
Cologne, North Rine Westphalia, 51147, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jörn Rittweger, Prof. Dr.
German Aerospace Center (DLR)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2012
First Posted
March 22, 2017
Study Start
March 1, 2011
Primary Completion
August 1, 2011
Study Completion
July 1, 2012
Last Updated
March 22, 2017
Record last verified: 2017-03