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

Primary Purpose

Muscle; Atrophy, General

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Hephaistos unloading orthosis

About this trial

This is an interventional basic science trial for Muscle; Atrophy, General focused on measuring weight bearing, muscle unloading, bone loss, arterial adaptation, muscular adaptation

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts 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

Sites / Locations

German Aerospace Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Hephaistos unloading orthosis

Arm 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.

Outcomes

Primary Outcome Measures

Bone density as measured with pQCT

Change from baseline to 14 days after immobilization phase

Secondary Outcome Measures

Structural and functional parameters of arterial adaptation

Change in intima & media thickness.

Structural and functional parameters of arterial adaptation

Change in arterial diameter

Structural and functional parameters of arterial adaptation

Change in blood flow

Structural and functional parameters of arterial adaptation

Change in flow-mediated dilation

Full Information

NCT ID

NCT03086187

First Posted

July 31, 2012

Last Updated

March 15, 2017

Sponsor

DLR German Aerospace Center

1. Study Identification

Unique Protocol Identification Number

NCT03086187

Brief Title

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

Acronym

HEP

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

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

DLR German Aerospace Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: Primary objective: Assessment and evaluation of bone adaptation. Secondary objective: Assessment and evaluation of functional and structural muscular adaptations. Third objective: Assessment and evaluation of functional and structural vascular adaptations. Fourth objective: Assessment and evaluation if the present findings deviate from findings observed in established unloading models.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Muscle; Atrophy, General

Keywords

weight bearing, muscle unloading, bone loss, arterial adaptation, muscular adaptation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hephaistos unloading orthosis

Arm Type

Other

Arm 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.

Intervention Type

Device

Intervention Name(s)

Hephaistos unloading orthosis

Intervention Description

The Hephaistos unloading orthosis greatly reduces plantarflexor muscle torque and plantarflexor muscle activation during any gait activity.

Primary Outcome Measure Information:

Title

Bone density as measured with pQCT

Description

Change from baseline to 14 days after immobilization phase

Time Frame

At baseline and up to 12 months after the immobilization phase

Secondary Outcome Measure Information:

Title

Structural and functional parameters of arterial adaptation

Description

Change in intima & media thickness.

Time Frame

At baseline and up to 12 months after the immobilization phase

Title

Structural and functional parameters of arterial adaptation

Description

Change in arterial diameter

Time Frame

At baseline and up to 12 months after the immobilization phase

Title

Structural and functional parameters of arterial adaptation

Description

Change in blood flow

Time Frame

At baseline and up to 12 months after the immobilization phase

Title

Structural and functional parameters of arterial adaptation

Description

Change in flow-mediated dilation

Time Frame

At baseline and up to 12 months after the immobilization phase

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jörn Rittweger, Prof. Dr.

Organizational Affiliation

German Aerospace Center (DLR)

Official's Role

Study Director

Facility Information:

Facility Name

German Aerospace Center

City

Cologne

State/Province

North Rine Westphalia

ZIP/Postal Code

51147

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Links:

URL

http://www.dlr.de

Description

Webpage of the German Aerospace Center (DLR)

Learn more about this trial

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

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