The Effects of the Novel Unloading Device "HEPHAISTOS" on Bone, Muscles and Vessels

German Aerospace Center (DLR)

Status: Completed

Conditions: Muscle; Atrophy, General

Treatments: Device: Hephaistos unloading orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT03086187

HEP

Details and patient eligibility

About

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.

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 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

11 participants in 1 patient group

Hephaistos unloading orthosis

Other group

Description:

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.

Treatment:

Device: Hephaistos unloading orthosis