Clinical trial NCT03086187: The Effects of the Novel Unloading Device "HEPHAISTOS" on Bone, Muscles and Vessels
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle; Atrophy, General
Keywords: weight bearing
muscle unloading
bone loss
arterial adaptation
muscular adaptation
Lead sponsor: DLR German Aerospace Center
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 11
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bone density as measured with pQCT
timeFrame: At baseline and up to 12 months after the immobilization phase
Secondary outcomes:
measure: Structural and functional parameters of arterial adaptation
timeFrame: At baseline and up to 12 months after the immobilization phase
measure: Structural and functional parameters of arterial adaptation
timeFrame: At baseline and up to 12 months after the immobilization phase
measure: Structural and functional parameters of arterial adaptation
timeFrame: At baseline and up to 12 months after the immobilization phase
measure: Structural and functional parameters of arterial adaptation
timeFrame: At baseline and up to 12 months after the immobilization phase
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: German Aerospace Center
state: North Rine Westphalia
Study officials:
affiliation: German Aerospace Center (DLR)
name: Jörn Rittweger, Prof. Dr.
role: STUDY_DIRECTOR
References: