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

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.

Study Overview

• Status: Completed
• Conditions: Muscle; Atrophy, General
• Intervention / Treatment: Device: Hephaistos unloading orthosis

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • North Rine Westphalia
    • Cologne, North Rine Westphalia, Germany, 51147
      • German Aerospace Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: Hephaistos unloading orthosis; The Hephaistos unloading orthosis greatly reduces plantarflexor muscle torque and plantarflexor muscle activation during any gait activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structural and functional parameters of arterial adaptation	Change in intima & media thickness.	At baseline and up to 12 months after the immobilization phase
Structural and functional parameters of arterial adaptation	Change in arterial diameter	At baseline and up to 12 months after the immobilization phase
Structural and functional parameters of arterial adaptation	Change in blood flow	At baseline and up to 12 months after the immobilization phase
Structural and functional parameters of arterial adaptation	Change in flow-mediated dilation	At baseline and up to 12 months after the immobilization phase

Collaborators and Investigators

• Sponsor: DLR German Aerospace Center
• Investigators: Study Director: Jörn Rittweger, Prof. Dr., German Aerospace Center (DLR)

Publications and helpful links

Helpful Links

• Webpage of the German Aerospace Center (DLR)

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: July 31, 2012
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (Actual): March 22, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2017
• Last Update Submitted That Met QC Criteria: March 15, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: bone loss; weight bearing; muscle unloading; arterial adaptation; muscular adaptation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy
• Other Study ID Numbers: HEP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided