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

German Aerospace Center (DLR)

Status: Completed

Conditions: Bone Resorption

Treatments: Device: HEPHAISTOS

Study type: Interventional

Funder types: Other

Identifiers

NCT01576081

DLR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Unilateral orthotic intervention

Experimental group

Description:

The HEPHAISTOS orthotic was worn unilaterally for 56days by 11 healthy male subjects.

Treatment:

Device: HEPHAISTOS