The Effects of the Novel Unloading Device "HEPHAISTOS" on Bone, Muscles and Vessels
NCT ID: NCT03086187
Last Updated: 2017-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2011-03-31
2012-07-31
Brief Summary
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It greatly reduces calf muscle forces without reducing ground reaction forces.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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.
Hephaistos unloading orthosis
The Hephaistos unloading orthosis greatly reduces plantarflexor muscle torque and plantarflexor muscle activation during any gait activity.
Interventions
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Hephaistos unloading orthosis
The Hephaistos unloading orthosis greatly reduces plantarflexor muscle torque and plantarflexor muscle activation during any gait activity.
Eligibility Criteria
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Inclusion Criteria
* age: 20-45
* BMI: 20-30
Exclusion Criteria
* 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
20 Years
45 Years
MALE
Yes
Sponsors
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DLR German Aerospace Center
OTHER
Responsible Party
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Principal Investigators
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Jörn Rittweger, Prof. Dr.
Role: STUDY_DIRECTOR
German Aerospace Center (DLR)
Locations
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German Aerospace Center
Cologne, North Rine Westphalia, Germany
Countries
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Related Links
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Webpage of the German Aerospace Center (DLR)
Other Identifiers
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HEP
Identifier Type: -
Identifier Source: org_study_id
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